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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 chronic lymphocytic leukemia (CLL). The safety of this treatment combination will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Lymphocytic Leukemia |
Drug: Lenalidomide Drug: Fludarabine Drug: Cyclophosphamide Drug: Rituximab Drug: Thymoglobulin Procedure: Stem Cell Transplantation Drug: Bendamustine Drug: Allopurinol |
Phase II |
| 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: Cyclophosphamide
750 mg/m^2 will be given intravenously daily on day -5, -4, -3 (following Fludarabine).
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:
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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: Cyclophosphamide
750 mg/m^2 will be given intravenously daily on day -5, -4, -3 (following Fludarabine).
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: | November 23, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Nonmyeloablative Stem Cell Transplantation Chronic Lymphocytic Leukemia CLL Immunomanipulation Cyclophosphamide |
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 Cyclophosphamide Antilymphocyte Serum |
Thalidomide Nitrogen Mustard Compounds Bendamustine Fludarabine Lenalidomide Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Gout Suppressants Antirheumatic Agents Therapeutic Uses Free Radical Scavengers Antioxidants Antimetabolites Protective Agents |