Status:
UNKNOWN
Study Evaluating the Effect of R-mabHDI in Lymphocytic Predominant Hodgkin's Lymphoma
Lead Sponsor:
American Scitech International
Collaborating Sponsors:
Eli Lilly and Company
Bristol-Myers Squibb
Conditions:
Hodgkin's Lymphoma
Eligibility:
All Genders
16-65 years
Phase:
PHASE3
Brief 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 hypoth...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2014
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00816959
Start Date
July 1 2011
End Date
April 1 2014
Last Update
July 20 2011
Active Locations (1)
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1
MedCenter
East Brunswick, New Jersey, United States, 08816