Clofarabine Followed By Lenalidomide for High-Risk Myelodysplastic Syndromes and Acute Myeloid Leukemia
Status:
Completed
Trial end date:
2018-06-27
Target enrollment:
Participant gender:
Summary
Background:
- Several types of blood cancer are associated with poor outcomes including high-risk
myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute
myelogenous leukemia (AML). Many people with MDS, CMML, and AML are not candidates for
standard treatments. New types of treatment are needed for these cancers.
- Clofarabine and lenalidomide are anticancer drugs. The first damages cancer cells in the
body. The second can alter blood supply to abnormal cells or affect how the immune
system attacks these cells. These drugs have been previously tested as treatments for
MDS and leukemia. However, they have not been tried as a combination for MDS, CMML, and
AML. Researchers want to see if these drugs are safe and effective for these types of
cancer.
Objectives:
- To test the safety and effectiveness of clofarabine and lenalidomide for people with
high-risk MDS, CMML, and AML.
Eligibility:
- Individuals at least 18 years of age who have high-risk MDS, CMML, and AML.
- Participants must not be candidates for standard treatments.
Design:
- Participants will be screened with a physical exam and medical history. Blood and bone
marrow samples will be collected.
- Participants will have 5 days of treatment with clofarabine. It will be given through a
vein during an inpatient hospital stay. If there are no serious side effects after the
infusion, participants will continue treatment as outpatients.
- After 28 days, participants will have a bone marrow biopsy to check their response to
treatment.
- After the biopsy, participants will start lenalidomide treatment. Half of the
participants will take the drug for 28 days (one treatment cycle). The other half will
take it for 56 days (two cycles). More blood tests and biopsies will be used to monitor
treatment.
- If there are no serious side effects and the disease does not become worse, participants
may keep taking lenalidomide at lower doses for up to 12 more cycles.