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| Sponsor: | Eastern Cooperative Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00843882 |
Purpose
RATIONALE: Lenalidomide may stop the growth of myelodysplastic syndrome by blocking blood flow to the cell. Colony stimulating factors, such as epoetin alfa, may increase the number of immune cells found in bone marrow or peripheral blood. It is not yet known whether lenalidomide is more effective with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia.
PURPOSE: This randomized phase III trial is studying lenalidomide to see how well it works with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Anemia Leukemia Myelodysplastic Syndromes |
Biological: epoetin alfa Drug: lenalidomide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment With Lenalidomide (Revlimid®) Alone and in Combination With Epoetin Alfa (Procrit®) in Subjects With Low- or Intermediate-1 Risk MDS and Symptomatic Anemia |
| Estimated Enrollment: | 236 |
| Study Start Date: | January 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I
Patients receive oral lenalidomide once daily on days 1-21.
|
Drug: lenalidomide
Given orally
|
|
Experimental: Arm II
Patients receive oral lenalidomide once daily on days 1-21 and epoetin alfa subcutaneously once weekly.
|
Biological: epoetin alfa
Given subcutaneously
Drug: lenalidomide
Given orally
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to erythropoietin level (≤ 500 mU/mL vs > 500 mU/mL) and prior erythropoietic growth factor (yes vs no). Patients are randomized to 1 of 2 treatment arms. Patients with del 5q31.1 karyotype are assigned to treatment arm I.
In both arms, treatment repeats every 28 days for 4 courses. Patients who achieve a major erythroid response (MER) may continue treatment beyond 4 courses in the absence of disease progression, disease conversion to acute myeloid leukemia, or unacceptable toxicity. Patients in arm I who fail to achieve MER or who achieve MER but relapse after 16 weeks of treatment with lenalidomide may crossover and receive treatment in arm II.
After completion of study treatment, patients are followed for 6 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Documented diagnosis of 1 of the following:
Myelodysplastic syndromes (MDS) lasting ≥ 3 months according to WHO criteria
International prognostic scoring system (IPSS) category of low- or intermediate-1-risk MDS as determined by cytogenetic analysis
Patients with cytogenetic failure and < 10% marrow blasts are eligible
Must have failed treatment with an erythropoietic growth factor OR have a low probability of response to rhu-erythropoietin, as defined by the following:
PATIENT CHARACTERISTICS:
No documented iron deficiency
PRIOR CONCURRENT THERAPY:
At least 28 days since prior non-transfusion therapy, including all types of growth factors, for MDS
Contacts and Locations
Show 308 Study Locations| Study Chair: | Alan F. List, MD | H. Lee Moffitt Cancer Center and Research Institute |
More Information
| Responsible Party: | Robert L. Comis, ECOG Group Chair's Office |
| ClinicalTrials.gov Identifier: | NCT00843882 History of Changes |
| Other Study ID Numbers: | CDR0000634119, ECOG-E2905 |
| Study First Received: | February 12, 2009 |
| Last Updated: | April 7, 2011 |
| Health Authority: | Unspecified |
|
de novo myelodysplastic syndromes previously treated myelodysplastic syndromes chronic myelomonocytic leukemia anemia |
|
Anemia Leukemia Myelodysplastic Syndromes Preleukemia Hematologic Diseases Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Precancerous Conditions Epoetin Alfa Lenalidomide Thalidomide Hematinics Hematologic Agents |
Therapeutic Uses Pharmacologic Actions Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |