Phase II Study of Lenalidomide in Patients With Relapsed/Refractory Acute Myelogenous Leukemia or High-Risk Myelodysplastic Syndrome Associated With Chromosome 5 Abnormalities
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with anesthetic, and a small amount of bone marrow is withdrawn through a large needle.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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rates (complete remissions (CR), complete remissions with incomplete platelet recovery [CRp] and partial responses)
Response for 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 MDS was defined based on the 2006 IWG criteria. All participants with MDS who achieved hematological CR, PR, marrow CR, and hematological improvement considered responders.
Following three 28-day cycles evaluated for response
Gautam Borthakur, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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