Revlimid in Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome
The goal of this clinical research study is to find out if Revlimid can help to control the disease in patients with relapsed/refractory acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS) with abnormalities in chromosome number 5. The safety of this treatment will also be studied.
Acute Myelogenous Leukemia
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Lenalidomide in Patients With Relapsed/Refractory Acute Myelogenous Leukemia or High-Risk Myelodysplastic Syndrome Associated With Chromosome 5 Abnormalities|
- Number of Participants With a Response (Complete Remissions (CR), Complete Remissions With Incomplete Platelet Recovery [CRp] and Partial Responses) [ Time Frame: Following three 28-day cycles evaluated for response ] [ Designated as safety issue: No ]Response for Acute Myeloid Leukemia (AML) according to 2003 International Working Group (IWG) criteria: CR required absolute neutrophil count (ANC) >1 * 10^9/L, platelet count ≥100 * 10^9/L, < 5% of blast cells in bone marrow. CRp: as above except platelet count <100 * 10^9/L. Partial remission: as CR except for presence of 5-25% marrow blasts and with a decrease of marrow blast at least 50%. Response for Myelodysplastic Syndrome (MDS) was defined based on the 2006 IWG criteria. All participants with MDS who achieved hematological CR, Partial Response (PR), marrow CR, and hematological improvement considered responders.
|Study Start Date:||January 2009|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
Revlimid is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. It is possible that it may help reduce or prevent the growth of cancer cells.
You will have a bone marrow aspiration performed before starting treatment (within 4 weeks) on this study and at about 12 weeks after starting treatment on this study. Your doctor may also decide to perform a bone marrow aspiration before 12 weeks to assess your response to treatment. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle.
If you are found to be eligible to take part in this study, you will take Revlimid once a day by mouth (with a full glass of water, at least 1 hour before or after a meal) for 21 days.
You will then have 7 days off of the study drug, which is considered a rest period. This entire period is considered 1 cycle of therapy (28 days). The number of treatment cycles you may have will depend on the response of your disease to treatment on this study. You will have blood drawn (about 3 tablespoons) to test for blood counts and chemistries before each treatment cycle. At the end of 3 cycles, your disease will be evaluated for response to the study treatment.
You will be required to return to M. D. Anderson once a month for the first 3 months on this study or as often as the study doctor thinks it is best.
After the first 3 months on this study, you may have blood drawn (about 3 tablespoons) for blood counts and chemistries at your regular doctor's office. The results of your blood tests will then be sent to the research nurse. Your side effects will be reviewed by a doctor or nurse by telephone (in addition to being reviewed in your study diary) before the start of each cycle of treatment. This phone call will last about 10 minutes each time.
You will be taken off this study if your disease gets worse or you experience any intolerable side effects. It is also possible that the study doctor may decide to take you off this study if your disease response is considered less than a complete response. You will have an end-of-study visit, if you are taken off this study for any reason. During the end-of-study visit, you will have blood drawn (about 3 tablespoons) for blood counts and chemistries. You will have an ECG. You may have a urine pregnancy test. You will also have a bone marrow aspiration performed.
This is an investigational study. Revlimid® (lenalidomide) is indicated for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Revlimid® is also approved in combination with dexamethasone for the treatment of patients with multiple myeloma that have received at least one prior therapy. In this case it will be considered investigational. Up to 30 patients will take part in this study. All will be enrolled at M. D. Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00360672
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Gautam Borthakur, MD||M.D. Anderson Cancer Center|