Dose-dense ABVD First Line Therapy in Early Stage Unfavorable Hodgkin's Lymphoma

February 8, 2018 updated by: Fondazione Italiana Linfomi ONLUS

Dose-dense ABVD as First Line Therapy in Early Stage Unfavorable Hodgkin's Lymphoma: a Phase II, Prospective, Multi-center Study

Prospective, multicenter, Phase II trial designed to assess whether intensification of ABVD (dd-ABVD) is feasible and can improve the outcome of patients with early stage Hodgkin Lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dose-density has been shown to be an important factor for complete remission rate and longterm survival in lymphomas.

The aims of this study were to find out whether intensification of ABVD (dd-ABVD) is feasible and can improve the outcome of patients with early stage Hodgkin Lymphoma. In view of emerging data on the role of early PET in defining prognosis in Hodgkin Lymphoma patients, the percentage of FDG-PET (fluorodeoxyglucose positron emission tomography) negativity after two cycle was chosen as the parameter to evaluate dd-ABVD activity.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Arezzo, Italy
        • UO Ematologia Ospedale San Donato
      • Bari, Italy
        • UO Ematologia con trapianto AOU Policlinico Consorziale
      • Biella, Italy
        • SOS Ematologia Divisione Medicina Interna Ospedale degli Infermi
      • Cagliari, Italy
        • Ematologia e CTMO Ospedale Businco
      • Catania, Italy
        • UOC Oncoematologia Garibaldi Nesima
      • Cosenza, Italy
        • UOC Ematologia Azienda Ospedaliera Cosenza
      • Firenze, Italy
        • Unità Funzionale di Ematologia AOU Careggi
      • Genova, Italy
        • Ematologia- AOU San Martino IRCCS - IST
      • Ivrea, Italy
        • SC Medicina Trasfusionale ed Ematologia SS Ematologia ASLTO4
      • Lecce, Italy
        • UO Ematologia PO Vito Fazzi
      • Meldola, Italy
        • IRST Meldola
      • Messina, Italy
        • SC Ematologia AO Riuniti Papardo Piemonte
      • Milano, Italy
        • UO Oncoematologia AO San Carlo Borromeo Unità Semplice di Trapianto Midollo
      • Modena, Italy
        • Centro Oncoematologico Policlinico
      • Napoli, Italy
        • Unità Complessa di Ematologia AO di Rilievo Nazionale A. Cardarelli
      • Novara, Italy
        • SCDU Ematologia Università Piemonte Orientale
      • Palermo, Italy
        • Oncoematologia e TMO Dopartimento Oncologia La Maddalena
      • Parma, Italy
        • UO Complessa di Ematologia Ospedale di Parma
      • Pavia, Italy
        • Clinica Ematologica Fondazione IRCCS Policlinico San Matteo
      • Pescara, Italy
        • Ematologia Ospedale Santo Spirito
      • Ravenna, Italy
        • UO Ematologia Ospedale Santa Maria delle Croci
      • Reggio Emilia, Italy
        • SC Ematologia Azienda Ospedaliera Arcispedale Santa Maria Nuova
      • Rimini, Italy
        • UO Oncoematologia AUSL Rimini Ospedale Infermi
      • Roma, Italy
        • Ematologia Università La Sapienza
      • Roma, Italy
        • Ematologia e Trapianto Istituto Regina Elena IFO
      • Roma, Italy
        • Ematologia Ospedale Sant'Andrea
      • Salerno, Italy
        • Ematologia e Trapianti AO San Giovanni di Dio e Ruggi D'Aragona
      • Siena, Italy
        • Azienda Ospedaliera Università Senese Clinica Ematologica Policlinico Le Scotte
      • Terni, Italy
        • Oncoematologia Università Perugia sede Terni
      • Torino, Italy
        • SC Ematologia AO Città della Salute e della Scienza
      • Udine, Italy
        • Clinica Ematologica AO S. Maria della Misericordia
      • Varese, Italy
        • UOC Ematologia Ospedale di Circolo
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy
        • UO Ematologia Casa Sollievo della Sofferenza
    • Milano
      • Rozzano, Milano, Italy
        • Dipartimento di Oncologia Medica ed Ematologia Istituto Clinico Humanitas
    • Palermo
      • Cefalù, Palermo, Italy
        • Oncologia HSR Giglio
    • Pordenone
      • Aviano, Pordenone, Italy
        • Oncologia Medica A Centro di Riferimento Oncologico
    • Salerno
      • Pagani, Salerno, Italy
        • U.O. Oncoematologia Ospedale "Andrea Tortora"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-70 years
  • Histologically confirmed Hodgkin Lymphoma stage I, II unfavorable according to EORTC (European Organisation for Research and Treatment of Cancer) criteria, with exclusion of stage II B bulky.
  • Previously untreated
  • ECOG (Eastern Cooperative Oncology Group) performance status 0 - 2
  • Staging with FDG-PET (fluorodeoxyglucose positron emission tomography)
  • Written informed consent
  • Adequate liver and renal function (total serum bilirubin < 2.5 x ULN, AST/SGOT and/or ALT/SGPT ≤ 2.5 x upper limit of normal (ULN) or ≤ 5.0 x ULN if the transaminase elevation is due to disease involvement, serum creatinine < 2.5 x ULN)

Exclusion Criteria:

  • Concomitant cardiac, pulmonary, neurologic, psychiatric or metabolic severe disease.
  • Uncontrolled diabetes mellitus (with fasting glucose levels above 200mg/dl)
  • Other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast or other cancer from which the patient has been disease-free for ≥ 3 years
  • Patients with a known history of HIV seropositivity
  • Active HCV infection (PCR + ; AST> 1.5-2x UN)
  • Woman who is pregnant or breast feeding. Fertile patients not willing to use effective contraception during the study and 3 months after the end of treatment. Women of childbearing potential (WOCBP) are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months.
  • Negative pregnancy test at baseline is required (serum β HCG).
  • Male patient whose sexual partner(s) are WOCBP who are not willing to use a effective contraception during the study and 3 months after the end of treatment
  • Nodular lymphocyte prevalence histological subtype

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dose dense ABVD
1 arm for all patients (dose dense ABVD on day 1 and 8 every 21 days)
Drug: dose dense ABVD

dose dense ABVD will be administered intravenously on day 1 and 8 every 21 days Chemotherapy regimen

  • Doxorubicin 25 mg/m2 i.v. day 1 and 8
  • Bleomycin 10 mg/m2 i.v. day 1 and 8
  • Vinblastine 6 mg/m2 i.v. day 1 and 8
  • Dacarbazine 375 mg/m2 i.v. day 1 and 8

Granulocyte colony-stimulating factor (G-CSF): days 9 to 14

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: After 4 dd-ABVD cycles (12 weeks after starting treatment)
Proportion of patient with a dose intensity reduction (lower than 85% of planned dose)
After 4 dd-ABVD cycles (12 weeks after starting treatment)
Activity
Time Frame: After 2 dd-ABVD cycles (6 week after starting treatment)
Percentage of FDG PET negativity after 2 dd-ABVD cycles will be considered as primary endpoints.
After 2 dd-ABVD cycles (6 week after starting treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall accuracy of each interim PET interpretation criteria after a minimum follow-up of three years
Time Frame: After 3 years of follow-up
Concordance between pet results and patients prognosis
After 3 years of follow-up
PFS
Time Frame: 2 years from the activation of therapy in the last patient enrolled onto the study.
Progression free survival estimate (prognosis outcome)
2 years from the activation of therapy in the last patient enrolled onto the study.
OS
Time Frame: 2 years from the activation of therapy in the last patient enrolled onto the study.
Overall survival estimate (prognosis outcome)
2 years from the activation of therapy in the last patient enrolled onto the study.
Toxicity
Time Frame: 2 years from the activation of therapy in the last patient enrolled onto the study.
Proportion of early and late toxicities (G3/4 acute toxicities, secondary malignancies, cardiovascular and pulmonary events, infertility)
2 years from the activation of therapy in the last patient enrolled onto the study.
Predictive Value of each interim PET interpretation criteria after a minimum follow-up of three years
Time Frame: After 3 years of follow-up
Concordance between pet results and patients prognosis
After 3 years of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Italiana Linfomi ONLUS

Investigators

  • Principal Investigator: Armando Santoro, M.D., Humanitas Cancer Center - Department of Medical Oncology and Haematology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

April 29, 2017

Study Registration Dates

First Submitted

March 7, 2014

First Submitted That Met QC Criteria

September 19, 2014

First Posted (Estimate)

September 25, 2014

Study Record Updates

Last Update Posted (Actual)

February 9, 2018

Last Update Submitted That Met QC Criteria

February 8, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIL - DDABVD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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