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

Fondazione Italiana Linfomi - ETS50 enrolled

Overview

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 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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hodgkin Lymphoma

Interventions

MBVD (Myocet+BVD)DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (26)

Azienda Ospedaliera SS. Antonio e Biagio e C. Arrigo

Alessandria, Alessandria, Italy

Outcomes

Primary Outcomes

Complete Response (CR) at the end of the chemotherapy program

CR is defined according to the Cheson 2007 response criteria.

Time frame: 24 weeks

Cardiac Toxicity during the chemotherapy program measured by CTCAE v.3

Evaluation of Cardiac Toxicity during the chemotherapy program measured by CTCAE v.3

Time frame: 24 weeks

Secondary Outcomes

Cardiac toxicity of MBVD after two courses of MBVD measured by CTCAE v.3

Evaluation of cardiac toxicity of MBVD in elderly and/or cardiopathic patients with Hodgkin's lymphoma after two courses of MBVD.

Time frame: 8 weeks

Progression Free Survival (PFS)

PFS will be measured from the day of enrolment to the date of disease progression, relapse or death due to any cause

Time frame: 24 months

Relapse Free Survival (RFS) of patients entering complete remission

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

Time frame: 24 months

Overall Survival (OS)

OS will be measured from the day of enrolment to the date of relapse or death due to any cause

Time frame: 24 months

Change from the theoretical total amount of drug delivered in a one-week period (dose-intensity)

Proportion of dose-intensity delivered to patients

Time frame: 24 weeks

Data from ClinicalTrials.gov

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