Phase III Randomized, Multi-center Study to Evaluate the Effect of R-mabHDI in Patients With Lymphocytic Predominant Hodgkin's Lymphoma
16 Years
65 Years
Both
Hodgkin's Lymphoma
Trial Information
Phase III Randomized, Multi-center Study to Evaluate the Effect of R-mabHDI in Patients With Lymphocytic Predominant Hodgkin's Lymphoma
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 .
A total of 1200 subjects will be recruited to the study from various centers. Enrollment
period will last for up to one and half year and treatment period is for six months.
Treatment will be considered a failure if the tumor size and signs of LPHD does not decrease
after 3 months.
Subjects having late stage HD, widespread HD or recurrent HD fulfilling the inclusion and
exclusion criteria will be recruited in this study. Females who are nursing babies or are
pregnant will be excluded from the study.
All subjects will receive the drugs according to the randomization process. The eligible
subjects will be randomly assigned to 1 of 2 "treatment" groups after screening. No matter
which group the subjects are assigned to, the doses of the drugs will be the standard doses
that are currently used to treat lymphoma.
Group 1: subjects assigned to group 1 will receive the ABVD combination intravenously for
about 1 hour on day 1 and 15 of every cycle (every 2 weeks). Each cycle is 4 weeks. ABVD
will to be given for 6 cycles.
The subjects will also receive R-mabHDI intravenously, separately for about 7 hours on
days 1,8,15 and 22 (once a week) of every cycle. Each cycle is 4 weeks. R-mabHDI will be
given for 2 cycles.
Group 2: subjects assigned to group 2 will receive the ABVD combination intravenously for
about 1 hour on day 1 and 15 of every cycle (every 2 weeks). Each cycle is 4 weeks. ABVD
will to be given for 6 cycles.
Subjects in group 2 will not receive R-mabHDI .
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The primary efficacy criterion is the response rates (RR) by Kaplan-Meier at 3,6,12, and 18 months.
Outcome Time Frame:
18 months
Safety Issue:
Yes
Principal Investigator
Ratna Grewal, MD.
Investigator Role:
Study Chair
Investigator Affiliation:
American Scitech International- eCRO
Authority:
United States: Institutional Review Board
Study ID:
ASI-HDIII 0109
NCT ID:
NCT00816959
Start Date:
July 2011
Completion Date:
April 2014
Related Keywords:
- Hodgkin's Lymphoma
- Lymphocytic Predominant Hodgkin's Lymphoma
- Late, widespread and recurrent LPHD
- Hodgkin Disease
- Lymphoma
Name | Location |
|---|---|
| MedCenter | East Brunswick, New Jersey 08816 |
