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B-CD30 + Hodgkin Lymphoma International Multi-center Retrospective Study of Treatment Practices and Outcomes (B-HOLISTIC)

3 de junho de 2021 atualizado por: Takeda

An International, Multi-centre, Non-interventional Retrospective Study to Describe Treatment Pathways, Outcomes, and Resource Use in Patients With Classical Hodgkin Lymphoma (B-HOLISTIC)

The purpose of this study is to describe progression-free survival (PFS) in participants with relapsed or refractory classical Hodgkin lymphoma (RRHL), defined as the time from initiation of first treatment for RRHL to first documentation of relapse or disease progression, or death.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

This is a retrospective, non-interventional study of participants with newly-diagnosed cHL, or with RRHL. The study will review the medical records of participants to describe participant's demographics, disease characteristics, treatments received, outcomes, health resources used by the participants, and adverse events that are associated with treatments, and resources used for treatment.

The study will enroll approximately 50 to 100 participants in each group at each of the 13 participating countries. Based on the diagnosis of the disease, participants will be assigned to one of the following groups:

Group 1: cHL Group 2: RRHL

This multi-center trial will be conducted in Argentina, Australia, China, Colombia, Hong Kong, Mexico, Republic of Korea, Russia, Saudi Arabia, Singapore, South Africa, Taiwan, and Turkey. The data for Group 1 and Group 2 will be collected from date of cHL or RRHL diagnosis until the date of death (or the date when the participant was last known to be alive, whichever occurs first).

Tipo de estudo

Observacional

Inscrição (Real)

1770

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Participants diagnosed with high-risk stage IIb-IV cHL and/or with RRHL between 01 January 2010 and 31st December 2013 from the 13 participating countries.

Descrição

Inclusion Criteria:

  1. Participants newly diagnosed with high-risk stage IIb-IV cHL (for Group 1) or RRHL (for Group 2) between 01 January 2010 and 31 December 2013.
  2. Age greater than or equal to (>=) 18 years at diagnosis of cHL (Group 1) or RRHL (Group 2).
  3. Alive or deceased.
  4. Written informed consent is obtained for study data collection, where necessary, according to local regulations.

Exclusion Criteria:

  1. Participants for whom the minimum study dataset is not available from their hospital medical records.
  2. Participants who have participated in an interventional clinical trial at any stage of their cHL (Group 1) or RRHL (Group 2) management.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Modelos de observação: Coorte
  • Perspectivas de Tempo: Retrospectivo

Coortes e Intervenções

Grupo / Coorte
Group 1: cHL
Participants diagnosed with high-risk stage IIb-IV cHL, received frontline treatment with chemotherapy with or without radiotherapy between 01 January 2010 and 31 December 2013 from the 13 participating countries will be observed for various treatments received for cHL, associated adverse events and resources used from the date of cHL diagnosis until the date of first documented relapse or disease progression after frontline therapy. Participants will be continue to be observed for overall survival until the date of death or data collection, whichever occurs first.
Group 2: RRHL
Participants diagnosed with RRHL, between 01 January 2010 and 31 December 2013 from the 13 participating countries will be observed for various treatments received for RRHL, detailed data on treatment pathways, clinical outcomes, associated adverse events and resources used from the date of RRHL diagnosis until the date death or data collection, whichever occurs first. Participants will be continue to be observed for overall survival until the date of death or data collection, whichever occurs first.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Group 2, RRHL: Progression Free Survival (PFS)
Prazo: From initiation of first treatment until first documentation of relapse/PD/until date of death (or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
PFS was defined as time from initiation of frontline regimen to first documentation of relapse or disease progression or death, censored at date of most recent follow-up/contact. Progressive disease (PD) was defined as any new lesion or increase by >=50% of previously involved site from nadir, and was evaluated based on International Working Group (IWG) criteria (Cheson et al 2007). Median PFS was estimated using the Kaplan-Meier method.
From initiation of first treatment until first documentation of relapse/PD/until date of death (or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis
Prazo: Day 1 at cHL diagnosis
The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (lessspread) to IV (more spread). Additional sub staging variables include: A, asymptomatic; and B, presence of B symptoms (including fever, night sweats and weight loss of >=10 percent [%] of body weight over 6 months).
Day 1 at cHL diagnosis
Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis
Prazo: Day 1 at RRHL diagnosis
The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (lessspread) to IV (more spread). Additional sub staging variables include: A, asymptomatic; and B, presence of B symptoms (including fever, night sweats and weight loss of >=10 % of body weight over 6 months).
Day 1 at RRHL diagnosis
Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis
Prazo: At second, third, fourth, and fifth relapse (up to 9 years 10 months)
The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (less spread) to IV (more spread). Additional sub staging variables include: A, asymptomatic; and B, presence of B symptoms (including fever, night sweats and weight loss of >=10% of body weight over 6 months).
At second, third, fourth, and fifth relapse (up to 9 years 10 months)
Group 1, cHL: Number of Participants Based on Each International Prognostic Score (IPS) Category
Prazo: Day 1 at cHL diagnosis
IPS score was calculated based on following factors: age >=45 years, male sex, stage IV disease, albumin<4 gram per liter (g/L), white blood cell (WBC)>=15*10^9 per liter (/L), haemoglobin <10.5 g/L, and lymphocyte count<0.6*10^6/L or <8% of differential. One point was assigned for each of above factors. The sum of points allotted correlates with following risk groups: good risk (0-1 points)-5 year survival of 89-90%; fair risk (2 to 3 points)-5 year survival of 78-81%; poor risk (4-7 points)-5 year survival of 56-61%. Total score range is 0 to 7, lower scores indicate higher survival rate.
Day 1 at cHL diagnosis
Group 1, cHL: Number of Participants With B Symptoms at Diagnosis
Prazo: Day 1 at cHL diagnosis
The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (less spread) to IV (more spread). If the following symptoms (B-symptoms) are present, a "B" classification is added to the stage: fever, night sweats and weight loss of >=10% of body weight over 6 months. B-symptoms indicate the presence of systemic symptoms. The presence or absence of B-symptoms has prognostic significance and is reflected in the staging of these lymphomas.
Day 1 at cHL diagnosis
Group 2, RRHL: Number of Participants With B Symptoms at Diagnosis
Prazo: Day 1 at RRHL diagnosis
The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (less spread) to IV (more spread). If the following symptoms (B-symptoms) are present, a "B" classification is added to the stage: fever, night sweats and weight loss of >=10% of body weight over 6 months. B-symptoms indicate the presence of systemic symptoms. The presence or absence of B-symptoms has prognostic significance and is reflected in the staging of these lymphomas.
Day 1 at RRHL diagnosis
Group 2, RRHL: Number of Participants Categorized Based on Prior Therapies for Hodgkin Lymphoma (HL) at Each Line of Treatment
Prazo: Day 1 at RRHL diagnosis
Number of participants were categorized based on prior therapies for HL at each line of treatment.
Day 1 at RRHL diagnosis
Group 2, RRHL: Median Number of Previous Treatment Regimens (Chemotherapies) Received
Prazo: Day 1 at RRHL diagnosis
Day 1 at RRHL diagnosis
Group 1, cHL: Number of Participants Categorized Based on Frontline Treatment Regimens
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Therapy regimens were numbered as 1: Doxorubicin (Doxo) + Bleomycin (bleo) + Vinblastine (Vinbl) + Decarbazine (Dacar) (ABVD); 3: Doxo + Vinbl + Mechlorethamine + Etoposide (Eto) + Vincristilne (Vinc) + Bleo + Prednisone (Pred) (Stanford V); 6: Cyclophophamide (Cyclo) + Vinc + Procarbazine (Procarb) + Pred (C-MOPP); 7: Dexamethasone + Cytarabine + Cisplatin (DHAP); 8: Eto + Methylprednisolone + Cytarabine + Cisplatin (ESHAP); 10: Ifosfamide+ Carboplatin + Eto (ICE); 11: Ifosfamide + Gemcitabine +Vinorelbine + Pred (IGEV); 17: Rituximab; 18: Brentuximab vedotin; 4: Bleo + Eto + Doxo + Cyclo + Vinc + Procarb + Pred (BEACOPP); 14: Cycl + Doxo + Vinc + Pred (CHOP); 15: Cycl + Vinc + Pred (CVP); 2: ABVD + Doxo + Bleo + Vinbl + Dacar then Bleo + Eto + Doxo + Cycl + Vinc + Procarb+ Pred ( Escalated BEACOPP); 24: Other.
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 1, cHL: Median Number of Treatment Cycles Associated With Each Frontline Treatment Regimen
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Therapy regimens were numbered as 1: ABVD; 3: Stanford V; 6: C-MOPP; 7: DHAP; 8: ESHAP; 10: ICE; 11: IGEV; 17: Rituximab; 18: Brentuximab vedotin; 4: BEACOPP; 14: CHOP; 15: CVP; 2: ABVD + Escalated BEACOPP; 24: Other.
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 1, cHL: Number of Participants Who Received Treatments for HL After Completion of Frontline Therapy (Before Relapse)
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Therapy regimens were numbered as 1: ABVD; 6: C-MOPP; 7: DHAP; 8: ESHAP; 10: ICE; 11: IGEV; 12: Carmustine + Cytarabine + Etoposide + Melphalan (Mini-BEAM); 13: Etoposide + Ifosfamide + Mesna + Mitoxantrone (MINE); 18: Brentuximab vedotin; 16: Gemcitabine + Vinoreilbine + Pegylated liposomal doxorubicin (GVD); 4: BEACOPP; 14: CHOP; 24: Other.
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 1, cHL: Number of Participants Categorized Based on RT Treatment Given as Pre-planned Frontline Treatment and RT Treatment Given for Residual Fluorodeoxyglucose (FDG)-Avid Disease
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Assessment was done for RT's whether used for pre-planned frontline treatment or for residual Fluorodeoxyglucose (FDG)-avid disease.
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Percentage of Participants Categorized Based on ASCT Eligibility Assessment
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Median Number of Treatment Cycles Associated With Relapse/ Refractory Treatment Regimen for ASCT
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Therapy regimens were numbered as 1: ABVD; 6: C-MOPP; 8: ESHAP; 11: IGEV; 12: Mini-BEAM; 18: Brentuximab vedotin; 22: Nivolumab; 24: Other.
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Reasons for Not Undergoing ASCT Despite Being ASCT Eligible
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Reasons for ASCT-eligible participants for not undergoing ASCT included participant refusal, inability to mobilize stem cells, loss of response to chemotherapy, cumulative toxicities, comorbid conditions, others, and unknown.
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Non-ASCT Participants Based on Reasons for ASCT Ineligibility
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Reasons for ASCT ineligibility included advanced age, comorbid conditions, chemoresistant disease, cumulative toxicities, and others.
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Therapy regimens were numbered as 1: ABVD; 2: ABVD followed by Escalated BEACOPP; 3: Stanford V; 4: BEACOPP; 6: Cyclophosphamide C-MOPP; 7: DHAP; 8: ESHAP; 9: GCD; 10: ICE; 11: IGEV; 12: Mini-BEAM; 13: MINE; 14: CHOP; 15: CVP; 16: GVD; 17: Rituximab; 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab; 23: Pembrolizumab; 24: Other. More than one line of treatment or therapy was selected for each participant.
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Percentage of Non-ASCT Participants for Whom Treatment is Palliative
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Percentage of Non-ASCT Participants Receiving Positron Emission Tomography (PET) or Computed Tomography (CT) at Each Line of Treatment Pathway
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Percentage of Non-ASCT Participants Receiving RT at Each Line of Treatment Pathway
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Median Frequency of PET or PET-CT Scan Assessment for Non-ASCT Participants
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants
Prazo: From initiation of first treatment until first documentation of relapse/PD/until date of death( or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Therapy regimens were numbered as 1: ABVD; 3: Stanford V; 6: C-MOPP; 7: DHAP; 11: IGEV; 19: Bendamustine; 4: BEACOPP; 13: MINE; 14: CHOP; 24: Other; 8: ESHAP; 9: Gemcitabine + Carboplatin + Dexamethasone (GCD); 10: ICE; 17: Rituximab; 18: Brentuximab vedotin; 15: CVP; 2: ABVD followed by Escalated BEACOPP; 22: Nivolumab; 16: GVD; 21: Lenalidomide; 24: Other.
From initiation of first treatment until first documentation of relapse/PD/until date of death( or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Duration of Each Line of Treatment in Non-ASCT Participants
Prazo: From initiation of first treatment until first documentation of relapse/PD/until date of death( or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initiation of first treatment until first documentation of relapse/PD/until date of death( or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Therapy regimens were numbered as 1: ABVD; 3: Stanford V; 6: C-MOPP; 7: DHAP; 11: IGEV; 4: BEACOPP; 14: CHOP; 15: CVP; 2: ABVD followed by Escalated BEACOPP; 24: Other; 8: ESHAP; 9: GCD; 10: ICE; 13: MINE; 17: Rituximab; 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab. More than one line of treatment or therapy was selected for each participant
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Time From Relapse (After Frontline Treatment) to First Treatment Post-relapse in Non-ASCT Participants
Prazo: From relapse after frontline treatment to first treatment post-relapse or until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From relapse after frontline treatment to first treatment post-relapse or until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Time to Initiation of Each Subsequent Treatment, From Relapse and Completion of Previous Treatment in Non-ASCT Participants
Prazo: From both relapse and from completion of previous treatment to initiation of each subsequent treatment (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From both relapse and from completion of previous treatment to initiation of each subsequent treatment (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site Received at Frontline
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site at Relapse/ Refractory
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Total Dose of Radiotherapies in Non-ASCT Participants
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of PET or CT Scan Assessments
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Therapy regimens were numbered as 8: ESHAP; 10: ICE; 11: IGEV; 12: Mini-BEAM; 18: Brentuximab vedotin; 19: Bendamustine; 16: GVD; 24: Other. Conditioning regimens are BEAM (Carmustine + Etoposide + Cytarabine + Melphalan), CBV (cyclophosphamide + Carmustine + vp16) BeEAM (bendamustine) and Gemcitabine/Busulfan/Melphalan.
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Participants Categorized Based on With Known Risk Factors for Relapse Post ASCT in Participants Undergoing ASCT
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Known risk factors for relapse after ASCT included time to first relapse less than or equal to (<=) 3 months, stage IV disease at relapse, bulky disease >=5 centimeter (cm) at relapse, extranodal disease, inadequate response to salvage chemotherapy (partial remission [PR] or PET positivity), performance status (eastern Cooperative oncology group [ECOG]) >=1. The ECOG assessment used a 3-point scale, including scores of 0 (fully active/able to carry on all pre-disease activities without restriction), 1 (restricted in physically strenuous activity but ambulatory/able to carry out light or sedentary work), or 2 (ambulatory for more than 50% of waking hours and capable of all self care but unable to carry out any work activities).
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Therapy regimens were numbered as 1: ABVD; 6: C-MOPP; 7: DHAP; 8: ESHAP; 9: GCD; 10: ICE; 11: IGEV; 12: Mini-BEAM; 13: Eto + Ifosfamide + Mesna + Mitoxantrone (MINE); 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab; 16: GVD; 4: BEACOPP; 14: CHOP; 2: ABVD + Escalated BEACOPP; 24: Other.
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Percentage of Participants Receiving Consolidation Therapy Post-ASCT in Participants Undergoing ASCT
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Median Duration of Treatment for Consolidation Therapies Used in Participants Undergoing ASCT
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Participants Categorized Based on Source of ASCT Procedures in Participants Undergoing ASCT
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Median Time From Relapse (After End of Frontline Treatment) to ASCT in Participants Undergoing ASCT
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: CD34+ Count Administered in Participants Undergoing ASCT
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Time From ASCT to First Relapse in Participants Who Relapse After ASCT
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Therapy regimens were numbered as 1: ABVD; 7: DHAP; 10: ICE; 11: IGEV; 4: BEACOPP; 2: ABVD followed by Escalated BEACOPP; 8: ESHAP; 12: Mini-BEAM; 13: MINE; 18: Brentuximab vedotin; 22: Nivolumab; 23: Pembrolizumab; 16: GVD, 9: GCD; 24: other; 19: Bendamustine; 14: CHOP; 17: Rituximab.
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Percentage of Participants Who Relapse After ASCT Categorized Based on Palliative Therapy Regimens
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Therapy regimens were numbered as 9: GVD; 10: ICE; 11: IGEV; 12: Mini-BEAM; 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab.
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Therapy regimens were numbered as 1: ABVD; 7: DHAP; 10: ICE; 11: IGEV; 4: BEACOPP; 2: ABVD followed by Escalated BEACOPP; 8: ESHAP; 12: Mini-BEAM; 13: MINE; 18: Brentuximab vedotin; 9: GCD; 22: Nivolumab; 23: Pembrolizumab; 16: GVD.
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Duration of Each Line of Treatment for Participants Who Relapse After ASCT
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Time From ASCT to First Treatment After Relapse in Participants Who Relapse After ASCT
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Time to Initiation of Each Subsequent Treatment, From ASCT and From Completion of Previous Treatment in Participants Who Relapse From ASCT
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Percentage of Participants Who Received PET-CT Scan, CT Scan and Radiotherapy at Each Stage of the Treatment Pathway in Participants Who Relapse After ASCT
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Data for PET-CT scan and CT scans were assessed for baseline, frontline and relapse/or refractory, and radiotherapy was assessed for frontline and relapse/refractory, as planned.
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Mean Frequency of PET or PET-CT Scan Assessments for Participants Who Relapse After ASCT
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Data for PET-CT scan and CT scans were assessed for baseline, frontline and relapse or refractory, as planned.
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Participants With Types of Radiotherapies Received at Frontline and at Relapse/Refractory in Participants Who Relapse After ASCT
Prazo: From initial diagnosis and until death or date of data collected, whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis and until death or date of data collected, whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Participants Categorized Based on Anatomical Site of Radiotherapies in Participants Who Relapse After ASCT at Frontline and at Relapse/Refractory
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Participants Categorized Based on Intent of Treatment of Radiotherapies in Participants Who Relapse After ASCT
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Total Dose of Radiotherapies Received at Frontline and Relapse/Refractory in Participants Who Relapse After ASCT
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Percentage of Participants Undergoing Subsequent ASCTs and Allogeneic Stem Cell Transplantation (Allo-SCT)
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Group 2, RRHL: Median Number of ASCTs for Each Participant Who Relapse After ASCT
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 1, cHL: Median PFS
Prazo: From initiation of frontline regimen to first documentation of relapse/PD/until date of death (or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
PFS was defined as time from initiation of frontline regimen to first documentation of relapse or disease progression or death, censored at date of most recent follow-up/contact. PD was defined as any new lesion or increase by >= 50% of previously involved site from nadir, and was evaluated based on IWG criteria (Cheson et al 2007). Median PFS was estimated using the Kaplan-Meier method.
From initiation of frontline regimen to first documentation of relapse/PD/until date of death (or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 1, cHL: Number of Participants Based on Best Clinical Response Post Completion of Frontline Treatment
Prazo: From post completion of frontline treatment until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Best clinical response as complete remission (CR), partial remission (PR), stable disease (SD), or PD was evaluated based on IWG criteria (Cheson et al 2007). CR was the disappearance of all evidence of disease. PR was the regression of measurable disease and no new sites. SD was defined by failure to achieve CR, PR, or PD. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir.
From post completion of frontline treatment until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment
Prazo: From post completion of frontline treatment until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Best clinical response as CR, PR, SD, or PD was evaluated based on IWG criteria (Cheson et al 2007). CR was the disappearance of all evidence of disease. PR was the regression of measurable disease and no new sites. SD was defined by failure to achieve CR, PR, or PD. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir.
From post completion of frontline treatment until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Mean Duration of Best Response
Prazo: From CR or PR until first documentation of relapse or disease progression or until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Duration of best response was defined as the time from when the criteria for response (CR or PR) were met to first documentation of relapse or disease progression, and was evaluated based on IWG criteria (Cheson et al 2007). CR was the disappearance of all evidence of disease. PR was the regression of measurable disease and no new sites. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir.
From CR or PR until first documentation of relapse or disease progression or until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Median Overall Survival (OS)
Prazo: From initial diagnosis until the date of death (or date when the participant was alive) (Group 1); From first relapse after frontline therapy to death (Group 2) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Median OS was defined as the time from diagnosis of cHL to death(Group 1)/ time from first relapse after frontline therapy to death (Group 2), censored at date of most recent follow-up/contact.
From initial diagnosis until the date of death (or date when the participant was alive) (Group 1); From first relapse after frontline therapy to death (Group 2) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 1, cHL: Overall Survival Rate After Diagnosis at 1 and 5 Years
Prazo: At 1 year and 5 years after diagnosis (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Percentage of participants who were alive at 1 and 5 years after diagnosis in cHL participants are reported. 5 year overall survival data were reported only for participants who had >5 year observation periods.
At 1 year and 5 years after diagnosis (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Overall Survival Rate at 1 and 5 Years
Prazo: At 1 year and 5 years after relapse (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Percentage of participants who were alive at 1 and 5 years after diagnosis in RRHL participants are reported. 5 year overall survival data were reported only for participants who had >5 year observation periods.
At 1 year and 5 years after relapse (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 1, cHL: Number of Participants Who Had Inpatient Hospital Admissions, Emergency Room Visits, and Outpatient Visits by Healthcare Professionals Related to HL
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 1, cHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 1, cHL: Mean Overall Length of Stay and Length of Stay by Unit/Ward for Inpatient Hospital Admissions Related to HL
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Length of stay by unit or ward included general, high dependency/intermediate, intensive care unit, bone marrow transplant unit, and emergency visits.
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 1, cHL: Number of Participants Categorized Based on Episodes of RT Received, Type of Scan or Procedure, and Who Received Granulocyte-colony Stimulating Factor (G-CSF) or High-cost Medicines and Pegylated G-CSF Related to HL
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 1, cHL: Mean Number of Courses of Treatment With G-CSF/Pegylated G-CSF or Other High-cost Medicines Related to HL Treatment
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Participants Who Had Inpatient Hospital Admissions, Emergency Room Visits, and Outpatient Visits by Healthcare Professional Related to HL for Salvage Therapy and ASCT
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Each participant had more than one category presented for salvage therapy and ASCT.
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL for Salvage Therapy and ASCT
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Each participant had more than one category presented for salvage therapy and ASCT.
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Mean Overall Length of Stay and Length of Stay by Unit/Ward for Inpatient Hospital Admissions Related to HL for Salvage Therapy and ASCT
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Length of stay by unit or ward included general, high dependency/intermediate, intensive care unit, bone marrow transplant unit, and emergency visits. Each participant had more than one category presented for salvage therapy and ASCT.
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Number of Participants Categorized Based on Episodes of RT, Type of Scan or Procedure, and Who Received G-CSF or High-cost Medicines Related to HL for Salvage Therapy and ASCT
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Each participant had more than one category presented for salvage therapy and ASCT. Scan procedures included chest x-ray, magnetic resonance imaging, needle biopsy, bone scan, bone marrow aspiration, flow cytometry, and other scan procedures.
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Group 2, RRHL: Group 2, RRHL: Mean Number of Courses of Treatment With G-CSF/Pegylated G-CSF or Other High-cost Medicines Related to HL Treatment for Salvage Therapy and ASCT
Prazo: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Takeda

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

21 de novembro de 2017

Conclusão Primária (Real)

31 de outubro de 2019

Conclusão do estudo (Real)

31 de outubro de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

27 de outubro de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de outubro de 2017

Primeira postagem (Real)

31 de outubro de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

25 de junho de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de junho de 2021

Última verificação

1 de junho de 2021

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CHL-5001

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Sim

Descrição do plano IPD

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Critérios de acesso de compartilhamento IPD

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Tipo de informação de suporte de compartilhamento de IPD

  • Protocolo de estudo
  • Plano de Análise Estatística (SAP)
  • Termo de Consentimento Livre e Esclarecido (TCLE)
  • Relatório de Estudo Clínico (CSR)

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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