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

NCT01523847 | Completed Phase 2

• 2 other identifiers: IIL - HD0803EudraCT Number 2009-013839-37
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 26

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.

Conditions

Hodgkin Lymphoma

Keywords

Hodgkin Lymphoma; Cardiopathic; elderly; Myocet

Outcome Measures

Primary Outcomes (2)

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

  CR is defined according to the Cheson 2007 response criteria.

  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

  24 weeks

Secondary Outcomes (6)

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

  8 weeks

• Progression Free Survival (PFS)

  24 months

• Relapse Free Survival (RFS) of patients entering complete remission

  24 months

• Overall Survival (OS)

  24 months

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

  24 weeks

Study Arms (1)

MBVD (Myocet+BVD)

EXPERIMENTAL

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)

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

Also known as: MBVD

MBVD (Myocet+BVD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Fondazione Italiana Linfomi - ETS: lead
• Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte: collaborator

Study Sites (26)

Azienda Ospedaliera SS. Antonio e Biagio e C. Arrigo

Alessandria, Alessandria, 15121, Italy

Location

Ospedale "A. Perrino"

Brindisi, Brindisi, 72100, Italy

Location

Ematologia Ospedale Vito Fazzi

Lecce, Lecce, 73100, Italy

Location

Ospedale Cardinale Giovanni Panico

Tricase, Lecce, 73039, Italy

Location

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

Civitanova Marche, Macerata, 62012, Italy

Location

Azienda Ospedaliera V.Cervello

Palermo, Palermo, 90146, Italy

Location

Ospedale Guglielmo da Saliceto

Piacenza, Piacenza, 29100, Italy

Location

Azienda Ospedaliera "Bianchi Melacrino Morelli"

Reggio Calabria, Reggio Calabria, 89124, Italy

Location

Ematologia Azienda Ospedaliera Arcispedale "S. Maria Nuova"

Reggio Emilia, Reggio Emilia, 42100, Italy

Location

Divisione di Oncologia Ospedale civile degli Infermi

Rimini, Rimini, 47900, Italy

Location

U.O.C. Ematologia IRCCS Istituti Fisioterapici Ospitalieri

Roma, Roma, 00144, Italy

Location

SC Medicina trasfusionale ed Ematologia Ospedale civile di Ivrea

Ivrea, Torino, 10015, Italy

Location

Struttura Complessa di Ematologia PO TREVISO

Treviso, Treviso, 31100, Italy

Location

Centro di riferimento Oncologico

Aviano, Italy

Location

IRCC Istituto Tumori

Bari, Italy

Location

Policlinico S. Orsola Malpighi

Bologna, Italy

Location

Spedali Civili

Brescia, Italy

Location

Ospedale Businco

Cagliari, Italy

Location

Area Vasta Romagna e IRST

Meldola (FC), Italy

Location

Ospedale Maggiore della Carità

Novara, Italy

Location

Fondazione Policlinico San Matteo

Pavia, Italy

Location

Osp. S. Maria delle Croci

Ravenna, Italy

Location

Ospedale S. Eugenio

Roma, Italy

Location

Università "La Sapienza"

Roma, Italy

Location

Ospedale Santa Maria

Terni, Italy

Location

Azienda Ospedaliero - Universitaria di Udine

Udine, Italy

Location

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Alessandro Levis, PhD

  Azienda Ospedaliera SS Antonio, Biagio e Cesare Arrigo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: February 1, 2012
• Study Start: November 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: August 4, 2016

Record last verified: 2016-08

Locations

IT (26)