Study Evaluating the Effect of R-mabHDI in Lymphocytic Predominant Hodgkin's Lymphoma

• Status: Unknown status
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Objective:

The primary objective of the study is to evaluate the effect of R-mabHDI in patients with late stage, widespread stage and recurrent Lymphocytic Predominant Hodgkin's Lymphoma.

The hypothesis is that the combination of R-mabHDI with the standard ABVD therapy in patients with late stage (Stage III and Stage IV) and recurrent stage Lymphocytic Predominant Hodgkin's Lymphoma will have a favorable outcome on the response and progress free survival. The study is also aimed at evaluating the safety of R-mabHDI .

The aim of the study is to test this hypothesis by evaluating the clinical outcome in 1200 patients receiving combination of R-mabHDI once a week for 8 weeks and ABVD therapy every other week for 12 treatments.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American Scitech International
• Collaborators: Bristol-Myers Squibb; Eli Lilly and Company; ImClone LLC
• Treatments: Bleomycin; Dacarbazine; Vinblastine

Criteria

Inclusion Criteria:

• Must sign the informed consent form

• Patients with proven diagnosis of Lymphocytic Predominant Hodgkin's Lymphoma in late stage HD, widespread HD and recurrent HD on histology.

• Patients of both gender

• Patients between ages of 16 and 65 years

• Patients must have bi-dimensionally measurable disease

• Patients with adequate bone marrow reserve (ANC>1500/mm3 ; Platelets> 50,000/ mm3)

• LVEF >/= 50% as measured by echocardiogram

• Serum creatinine < 2mg/dl

• Serum bilirubin < 2mg/dl; AST or ALT < 2x ULN

• International Prognostic Score of >2 (Patients must have > 2 of the following risk features: Male >/= 45 years of age, Stage IV, Albumin <4, WBC >/= 15, Lymphocytes < 8% or < 600, Hb < 10.5)

Exclusion Criteria:

• Classic Hodgkin's disease

• Known HIV infection

• Pregnant women and women of child bearing capacity, tests positive on a urine/blood pregnancy test, is lactating/nursing, has had three or more days of amenorrhea at the time of first dose of the treatment, is contemplating pregnancy in next six months or is not using an efficient contraceptive method.

• Severe pulmonary disease as judged by the Principal Investigator including COPD and asthma

• Acute infection requiring treatment with intravenous therapy

• Presence of CNS lymphoma

• Concomitant malignancies or previous malignancies within the last 5 years

• Active Hepatitis B or C infection

• Uncontrolled active infection

• Concurrent prednisone or systemic steroid therapy