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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Celgene Corporation |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00899431 |
Purpose
The goal of this clinical research study is to learn if lenalidomide, when given with a stem cell transplant and chemotherapy (bendamustine, fludarabine, and rituximab), can help to control CLL. The safety of this treatment combination will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Lymphocytic Leukemia |
Drug: Lenalidomide Drug: Fludarabine Drug: Rituximab Drug: Thymoglobulin Procedure: Stem Cell Transplantation Drug: Bendamustine Drug: Allopurinol |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Nonmyeloablative Stem Cell Transplantation With or Without Lenalidomide for Chronic Lymphocytic Leukemia (RV-CLL-PI-0294) |
| Estimated Enrollment: | 80 |
| Study Start Date: | May 2009 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group 1: Lenalidomide
Chemotherapy, Plus Lenalidomide
|
Drug: Lenalidomide
Starting dose 5 mg by mouth every other day; increase to 5 mg/d daily in 4-5 weeks for 6 - 12 months
Other Names:
Drug: Fludarabine
30 mg/m^2 intravenously daily on days -5, -4, -3.
Other Names:
Drug: Rituximab
375 mg/m2 intravenously on day -13, and 1000 mg/m^2 on days -6, +1 and +8.
Other Name: Rituxan
Drug: Thymoglobulin
1.0 mg/kg intravenously over 4 hours (day -2 and -1).
Other Names:
Procedure: Stem Cell Transplantation
On Day 0, donor blood stem cells collected will be transplanted over 30-45 minutes.
Other Names:
Drug: Bendamustine
130 mg/m2/day by vein daily on day -5, -4, -3 (following Fludarabine).
Other Names:
Drug: Allopurinol
300 mg by mouth daily beginning at the start of lenalidomide therapy and continuing for 3 months.
Other Names:
|
|
Active Comparator: Group 2: No Lenalidomide
Chemotherapy Treatment, No Lenalidomide.
|
Drug: Fludarabine
30 mg/m^2 intravenously daily on days -5, -4, -3.
Other Names:
Drug: Rituximab
375 mg/m2 intravenously on day -13, and 1000 mg/m^2 on days -6, +1 and +8.
Other Name: Rituxan
Drug: Thymoglobulin
1.0 mg/kg intravenously over 4 hours (day -2 and -1).
Other Names:
Procedure: Stem Cell Transplantation
On Day 0, donor blood stem cells collected will be transplanted over 30-45 minutes.
Other Names:
Drug: Bendamustine
130 mg/m2/day by vein daily on day -5, -4, -3 (following Fludarabine).
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Issa F. Khouri, MD, BS | 713-792-8750 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Issa F. Khouri, MD, BS | |
| Study Chair: | Issa F. Khouri, MD, BS | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00899431 History of Changes |
| Other Study ID Numbers: | 2007-0871 |
| Study First Received: | May 8, 2009 |
| Last Updated: | May 1, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Nonmyeloablative Stem Cell Transplantation Chronic Lymphocytic Leukemia CLL Immunomanipulation Fludarabine |
Lenalidomide Rituximab Thymoglobulin Stem Cell Transplantation |
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Allopurinol Fludarabine monophosphate Rituximab Antilymphocyte Serum Thalidomide |
Bendamustine Fludarabine Lenalidomide Nitrogen Mustard Compounds Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Gout Suppressants Antirheumatic Agents Therapeutic Uses Free Radical Scavengers Antioxidants Antimetabolites Protective Agents Physiological Effects of Drugs |