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| Sponsors and Collaborators: |
American Scitech International ImClone LLC Bristol-Myers Squibb |
|---|---|
| Information provided by: | American Scitech International |
| ClinicalTrials.gov Identifier: | NCT00816959 |
Purpose
Objective:
The primary objective of the study is to evaluate the effect of Rituximab in patients with late stage, widespread stage and recurrent Lymphocytic Predominant Hodgkin's Lymphoma. The hypothesis is that the combination of Rituximab 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 Rituximab. The aim of the study is to test this hypothesis by evaluating the clinical outcome in 1200 patients receiving combination of Rituximab once a week for 8 weeks and ABVD therapy every other week for 12 treatments.
| Condition | Intervention | Phase |
|---|---|---|
|
Hodgkin's Lymphoma |
Drug: Rituximab and ABVD Drug: ABVD |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase III Randomized, Multi-center Study to Evaluate the Effect of Rituximab in Patients With Lymphocytic Predominant Hodgkin's Lymphoma |
| Estimated Enrollment: | 1200 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Arm I: Rituximab and ABVD: Active Comparator |
Drug: Rituximab and ABVD
The subjects will receive Rituximab intravenously, separately for about 7 hours on days 1,8,15 and 22 (once a week) of every cycle. Each cycle is 4 weeks. Rituximab will be given for 2 cycles. Also the subjects 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 be given for 6 cycles. |
| Arm II: ABVD: Active Comparator |
Drug: ABVD
The subjects 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 be given for 6 cycles.
|
The primary objective of the study is to evaluate the effect of Rituximab in Patients with late stage, widespread stage and recurrent Lymphocytic Predominant Hodgkin's Lymphoma. The hypothesis is that the combination of Rituximab 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 Rituximab. 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 Rituximab intravenously, separately for about 7 hours on days 1,8,15 and 22 (once a week) of every cycle. Each cycle is 4 weeks. Rituximab 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 Rituximab.
Eligibility| Ages Eligible for Study: | 16 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ratna Grewal, MD | 732-981-8686 | rgreywal@americanscitech.com |
| United States, New Jersey | |
| MedCenter | |
| East Brunswick, New Jersey, United States, 08816 | |
| Study Chair: | Ratna Grewal, MD. | American Scitech International- eCRO |
| Principal Investigator: | Sarath Babu, MD. | MedCenter Primary and Internal Medicine |
More Information
| Responsible Party: | American Scitech International ( Ratna Grewal MD. ) |
| Study ID Numbers: | ASI-HDIII 0109 |
| Study First Received: | January 5, 2009 |
| Last Updated: | August 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00816959 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Lymphocytic Predominant Hodgkin's Lymphoma Late, widespread and recurrent LPHD |
|
Immunoproliferative Disorders Dacarbazine Immunologic Factors Hodgkin Lymphoma, Adult Rituximab Hodgkin's Disease Vinblastine Bleomycin |
Recurrence Doxorubicin Lymphatic Diseases Antirheumatic Agents Lymphoproliferative Disorders Lymphoma Hodgkin Disease |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Immunologic Factors Antineoplastic Agents Rituximab Physiological Effects of Drugs Pharmacologic Actions |
Lymphatic Diseases Neoplasms Therapeutic Uses Lymphoproliferative Disorders Antirheumatic Agents Hodgkin Disease Lymphoma |
