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

NCT ID: NCT01523847

Last Updated: 2016-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-10-31

Brief Summary

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.

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.

Conditions

Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MBVD (Myocet+BVD)

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

MBVD

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed Hodgkin's lymphoma, except for nodular lymphocyte predominance subgroup.
• Previously untreated
• Age ≥ 70.
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: collaborator

Fondazione Italiana Linfomi - ETS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alessandro Levis, PhD

Role: STUDY_DIRECTOR

Azienda Ospedaliera SS Antonio, Biagio e Cesare Arrigo

Locations

Azienda Ospedaliera SS. Antonio e Biagio e C. Arrigo

Alessandria, Alessandria, Italy

Ospedale "A. Perrino"

Brindisi, Brindisi, Italy

Ematologia Ospedale Vito Fazzi

Lecce, Lecce, Italy

Ospedale Cardinale Giovanni Panico

Tricase, Lecce, Italy

A.S.U.R. Zona Territoriale n°8 - Ospedale di Civitanova Marche U.O. Medicina Interna ed Ematologia

Civitanova Marche, Macerata, Italy

Azienda Ospedaliera V.Cervello

Palermo, Palermo, Italy

Ospedale Guglielmo da Saliceto

Piacenza, Piacenza, Italy

Azienda Ospedaliera "Bianchi Melacrino Morelli"

Reggio Calabria, Reggio Calabria, Italy

Ematologia Azienda Ospedaliera Arcispedale "S. Maria Nuova"

Reggio Emilia, Reggio Emilia, Italy

Divisione di Oncologia Ospedale civile degli Infermi

Rimini, Rimini, Italy

U.O.C. Ematologia IRCCS Istituti Fisioterapici Ospitalieri

Roma, Roma, Italy

SC Medicina trasfusionale ed Ematologia Ospedale civile di Ivrea

Ivrea, Torino, Italy

Struttura Complessa di Ematologia PO TREVISO

Treviso, Treviso, Italy

Centro di riferimento Oncologico

Aviano, , Italy

IRCC Istituto Tumori

Bari, , Italy

Policlinico S. Orsola Malpighi

Bologna, , Italy

Spedali Civili

Brescia, , Italy

Ospedale Businco

Cagliari, , Italy

Area Vasta Romagna e IRST

Meldola (FC), , Italy

Ospedale Maggiore della Carità

Novara, , Italy

Fondazione Policlinico San Matteo

Pavia, , Italy

Osp. S. Maria delle Croci

Ravenna, , Italy

Ospedale S. Eugenio

Roma, , Italy

Università "La Sapienza"

Roma, , Italy

Ospedale Santa Maria

Terni, , Italy

Azienda Ospedaliero - Universitaria di Udine

Udine, , Italy

Countries

Italy

Other Identifiers

EudraCT Number 2009-013839-37

Identifier Type: -

Identifier Source: secondary_id

IIL - HD0803

Identifier Type: -

Identifier Source: org_study_id