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

Phase 2
18 Years
Open (Enrolling)
Hodgkin Lymphoma

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Trial Information

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

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+ and occult
carriers (AntiHBc+, HbsAg-, AntiHBs+/-) Lamivudine prophilaxis 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 bilirubine 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 co-morbidities will be scored
and recorded, but they are not, if isolated, a sufficient reason for exclusion.

- Frail patients, defined accordino 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

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Description:

CR is defined according to the Cheson 2007 response criteria.

Outcome Time Frame:

24 weeks

Safety Issue:


Principal Investigator

Alessandro Levis, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Azienda Ospedaliera SS Antonio, Biagio e Cesare Arrigo


Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Study ID:

IIL - HD0803



Start Date:

November 2010

Completion Date:

August 2015

Related Keywords:

  • Hodgkin Lymphoma
  • Hodgkin Lymphoma
  • Cardiophatic
  • elderly
  • Myocet
  • Hodgkin Disease
  • Lymphoma