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

Hodgkin Lymphoma Clinical Trial

— HD0803  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01523847
• Other study ID #: IIL - HD0803
• Secondary ID: EudraCT Number 2
• Status: Completed
• Phase: Phase 2
• First received: June 22, 2011
• Last updated: August 3, 2016
• Start date: November 2010
• Est. completion date: October 2013

Study information

• Verified date: August 2016
• Source: Fondazione Italiana Linfomi ONLUS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Italiana Linfomi ONLUS	Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Response (CR) at the end of the chemotherapy program	CR is defined according to the Cheson 2007 response criteria.	24 weeks	No
Primary	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	Yes
Secondary	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.	8 weeks	Yes
Secondary	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	24 months	No
Secondary	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	24 months	No
Secondary	Overall Survival (OS)	OS will be measured from the day of enrolment to the date of relapse or death due to any cause	24 months	No
Secondary	Change from the theoretical total amount of drug delivered in a one-week period (dose-intensity)	Proportion of dose-intensity delivered to patients	24 weeks	No
Secondary	Change in cardiac markers during and at the end of chemotherapy	Evaluate Change in cardiac markers during and at the end of chemotherapy	24 weeks	Yes