A Multi-centre Study of MBVD in Elderly and/or Cardiopathic Patients Affected by Hodgkin's Lymphoma (HL) (HD0803)

August 3, 2016 updated by: Fondazione Italiana Linfomi ONLUS

A Phase II Multi-centre Study of MBVD in Elderly and/or Cardiopathic Patients Affected by Hodgkin's Lymphoma (HL)

The study has the purpose to evaluate in elderly and/or cardiopathic HL patients, the cardiologic toxicity of the MBVD regimen, where liposomal doxorubicin (Myocet®) is substituted for doxorubicin in the conventional ABVD regimen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

STUDY POPULATION Patients affected by Hodgkin's lymphoma, any stage, older than 69 years. Patients affected by Hodgkin's Lymphoma with concomitant cardiopaty, older than 18 years.

AIMS OF THE STUDY

  • To evaluate in elderly and/or cardiopathic HL patients, the cardiologic toxicity of the MBVD regimen, where liposomal doxorubicin (Myocet®) is substituted for doxorubicin in the conventional ABVD regimen
  • To compare in a pair-match retrospective analysis the results obtained with MBVD with those obtained in patients comparable for clinical variables and treated with ABVD or with the reduced intensity VEPEMB schedule.

STUDY DESIGN Multi-centre phase II study SAMPLE SIZE 50 patients

STUDY PROCEDURES

  • Histologic diagnosis of Hodgkin Lymphoma.

  • Early Staging evaluation including:

    • Blood tests
    • CT, PET and bone marrow biopsy.
    • Heart and lung function evaluation.
    • Geriatric assessment.
    • Quality of life evaluation.
  • 2 MBVD courses
  • Early restaging with PET scan (PET-2)

  • The subsequent treatment will be planned as follows:

    • Stage I and IIA patients will go on with 1 more course of MBVD (total of 3 courses) followed by involved field radiotherapy (30 Gy-36Gy).
    • Advanced stage (IIB-IV) patients will go on with 4 more courses of MBVD (total of 6 courses). Radiotherapy limited to bulky or non complete responder areas (30-36 Gy) is optional.

  • Final restaging including:

    • Blood tests
    • CT, PET
    • bone marrow biopsy if positive at baseline.
    • Heart and lung function evaluation.
    • Geriatric assessment.
    • Quality of life evaluation

Follow up procedures will include:

  1. a clinical and laboratory evaluation (with troponin, proBNP / BNP, cardiology visit, ECG and echocardiogram) every 6 months in the first 2 years, then annually.
  2. CT scans will be planned annually.
  3. Compilation of geriatric evaluation scales every 6 months in the first 2 years, then annually.

MBVD will be scheduled as follows (4 weeks):

Myocet 25 mg/mq i.v. day 1 and 15 Bleomycin 10 mg/mq i.v. day 1 and 15 Vinblastine 6 mg/mq i.v. day 1 and 15 Dacarbazine 375 mg/mq i.v. day 1 and 15 Supportive treatment with G-CSF and/or Erythropoietin will be planned according to international guide-lines.

Study Type

Interventional

Enrollment (Actual)

50

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
      • Alessandria, Italy, 15121
        • Azienda Ospedaliera SS. Antonio e Biagio e C. Arrigo
      • Aviano, Italy
        • Centro di riferimento Oncologico
      • Bari, Italy
        • IRCC Istituto Tumori
      • Bologna, Italy
        • Policlinico S. Orsola Malpighi
      • Brescia, Italy
        • Spedali Civili
      • Brindisi, Italy, 72100
        • Ospedale "A. Perrino"
      • Cagliari, Italy
        • Ospedale Businco
      • Lecce, Italy, 73100
        • Ematologia Ospedale Vito Fazzi
      • Meldola (FC), Italy
        • Area Vasta Romagna e IRST
      • Novara, Italy
        • Ospedale Maggiore della Carità
      • Palermo, Italy, 90146
        • Azienda Ospedaliera V.Cervello
      • Pavia, Italy
        • Fondazione Policlinico San Matteo
      • Piacenza, Italy, 29100
        • Ospedale Guglielmo da Saliceto
      • Ravenna, Italy
        • Osp. S. Maria delle Croci
      • Reggio Calabria, Italy, 89124
        • Azienda Ospedaliera "Bianchi Melacrino Morelli"
      • Reggio Emilia, Italy, 42100
        • Ematologia Azienda Ospedaliera Arcispedale "S. Maria Nuova"
      • Rimini, Italy, 47900
        • Divisione di Oncologia Ospedale civile degli Infermi
      • Roma, Italy
        • Ospedale S. Eugenio
      • Roma, Italy, 00144
        • U.O.C. Ematologia IRCCS Istituti Fisioterapici Ospitalieri
      • Roma, Italy
        • Università "La Sapienza"
      • Terni, Italy
        • Ospedale Santa Maria
      • Treviso, Italy, 31100
        • Struttura Complessa di Ematologia PO TREVISO
      • Udine, Italy
        • Azienda Ospedaliero - Universitaria di Udine
    • Lecce
      • Tricase, Lecce, Italy, 73039
        • Ospedale Cardinale Giovanni Panico
    • Macerata
      • Civitanova Marche, Macerata, Italy, 62012
        • A.S.U.R. Zona Territoriale n°8 - Ospedale di Civitanova Marche U.O. Medicina Interna ed Ematologia
    • Torino
      • Ivrea, Torino, Italy, 10015
        • SC Medicina trasfusionale ed Ematologia Ospedale civile di Ivrea

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed Hodgkin's lymphoma, except for nodular lymphocyte predominance subgroup.
  • Previously untreated
  • Age ≥ 70.
  • Age> 18 in presence of cardiopathy according to inclusion criteria…
  • Patients with HCV and HBV infection can be included. For patients HBV+ occult carriers (AntiHBc+, HbsAg-, AntiHBs+/-) Lamivudine prophylaxis is mandatory.
  • Life expectancy >3 months
  • Informed consent.
  • Staging with PET-CT.
  • Preliminary geriatric assessment (ADL, IADL, co-morbidity and frailness scores).

Exclusion Criteria:

  • Lymphocyte predominance subgroup
  • Age < 70 (no cardiopathy)
  • Age < 18 (with cardiopathy).
  • HIV infection.
  • Previous treatments for Hodgkin's lymphoma.
  • Other concomitant or previous malignancies, with the exception of basal cell skin tumors, adequately treated carcinoma in situ of the cervix and any cancer that has been in complete remission for > 5 years.
  • Renal failure (creatinine higher than twice the normal level) or liver disease (AST/ALT or bilirubin level higher than 2.5 times the normal level)
  • Other clinical situations that contraindicate, to the judgment of investigators, the administration of a mild-dose chemotherapy. Isolated comorbidities will be scored and recorded, but they are not, if isolated, a sufficient reason for exclusion.
  • Frail patients, defined according to comorbidity scale: patients with 1 grade 4 comorbidity, or >3 grade 3 comorbidities, are excluded. (see appendix.6)
  • Unresponsive sepsis
  • Dementia
  • Impossibility to subscribe the informed consent

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: MBVD (Myocet+BVD)

2 MBVD courses, after early restaging with PET scan (PET-2)

The subsequent treatment will be planned as follows:

  • -Stage I and IIA patients will go on with 1 more course of MBVD (total of 3 courses) followed by involved field radiotherapy (30 Gy-36 Gy).
  • -Advanced stage (IIB-IV) patients will go on with 4 more courses of MBVD (total of 6 courses). Radiotherapy limited to bulky or non complete responder areas (30 Gy) is optional.
Drug: MBVD (Myocet+BVD)

MBVD will be scheduled as follows:

Myocet 25 mg/mq i.v. day 1 and 15 Bleomycin 10 mg/mq i.v. day 1 and 15 Vinblastine 6 mg/mq i.v. day 1 and 15 Dacarbazine 375 mg/mq i.v. day 1 and 15

Other Names:
  • MBVD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response (CR) at the end of the chemotherapy program
Time Frame: 24 weeks
CR is defined according to the Cheson 2007 response criteria.
24 weeks
Cardiac Toxicity during the chemotherapy program measured by CTCAE v.3
Time Frame: 24 weeks
Evaluation of Cardiac Toxicity during the chemotherapy program measured by CTCAE v.3
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac toxicity of MBVD after two courses of MBVD measured by CTCAE v.3
Time Frame: 8 weeks
Evaluation of cardiac toxicity of MBVD in elderly and/or cardiopathic patients with Hodgkin's lymphoma after two courses of MBVD.
8 weeks
Progression Free Survival (PFS)
Time Frame: 24 months
PFS will be measured from the day of enrolment to the date of disease progression, relapse or death due to any cause
24 months
Relapse Free Survival (RFS) of patients entering complete remission
Time Frame: 24 months
RFS is defined only for patients who achieve CR, and is measured from the date of attaining the disease-free state until the date of relapse or death from any cause
24 months
Overall Survival (OS)
Time Frame: 24 months
OS will be measured from the day of enrolment to the date of relapse or death due to any cause
24 months
Change from the theoretical total amount of drug delivered in a one-week period (dose-intensity)
Time Frame: 24 weeks
Proportion of dose-intensity delivered to patients
24 weeks
Change in cardiac markers during and at the end of chemotherapy
Time Frame: 24 weeks
Evaluate Change in cardiac markers during and at the end of chemotherapy
24 weeks

Collaborators and Investigators

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

Sponsor

Fondazione Italiana Linfomi ONLUS

Collaborators

Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

Investigators

  • Study Director: Alessandro Levis, PhD, Azienda Ospedaliera SS Antonio, Biagio e Cesare Arrigo

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

November 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

June 22, 2011

First Submitted That Met QC Criteria

January 30, 2012

First Posted (Estimate)

February 1, 2012

Study Record Updates

Last Update Posted (Estimate)

August 4, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIL - HD0803
  • EudraCT Number 2009-013839-37

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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