Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier:
NCT01523847
First received: June 22, 2011
Last updated: November 14, 2013
Last verified: November 2013

June 22, 2011
November 14, 2013
November 2010
October 2013   (final data collection date for primary outcome measure)
  • Complete Response (CR) at the end of the chemotherapy program [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    CR is defined according to the Cheson 2007 response criteria.
  • Cardiac Toxicity during the chemotherapy program measured by CTCAE v.3 [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Evaluation of Cardiac Toxicity during the chemotherapy program measured by CTCAE v.3
Same as current
Complete list of historical versions of study NCT01523847 on ClinicalTrials.gov Archive Site
  • Cardiac toxicity of MBVD after two courses of MBVD measured by CTCAE v.3 [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Evaluation of cardiac toxicity of MBVD in elderly and/or cardiopathic patients with Hodgkin's lymphoma after two courses of MBVD.
  • Progression Free Survival (PFS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    PFS will be measured from the day of enrolment to the date of disease progression, relapse or death due to any cause
  • Relapse Free Survival (RFS) of patients entering complete remission [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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
  • Overall Survival (OS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    OS will be measured from the day of enrolment to the date of relapse or death due to any cause
  • Change from the theoretical total amount of drug delivered in a one-week period (dose-intensity) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Proportion of dose-intensity delivered to patients
  • Change in cardiac markers during and at the end of chemotherapy [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Evaluate Change in cardiac markers during and at the end of chemotherapy
Same as current
Not Provided
Not Provided
 
A Multi-centre Study of MBVD in Elderly and/or Cardiopathic Patients Affected by Hodgkin's Lymphoma (HL)
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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hodgkin Lymphoma
Drug: MBVD

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

Experimental: Arm1: MBVD

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.
Intervention: Drug: MBVD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01523847
IIL - HD0803, EudraCT Number 2009-013839-37
No
Fondazione Italiana Linfomi ONLUS
Fondazione Italiana Linfomi ONLUS
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Study Director: Alessandro Levis, PhD Azienda Ospedaliera SS Antonio, Biagio e Cesare Arrigo
Fondazione Italiana Linfomi ONLUS
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP