Clofarabine Followed By Lenalidomide for High-Risk Myelodysplastic Syndromes and Acute Myeloid Leukemia

Completed · Phase 1

Conditions studied: Myeldysplastic Syndrome (MDS), Chronic Myelomonocytic Leukemia, Bone Marrow Diseases, Neutropenia, Acute Myeloid Leukemia (AML)

In brief

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.

Key facts

Study ID

NCT01629082

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

4

Starts

2012-06-06

Expected to finish

2018-06-27

Last updated by the study team

2019-12-17

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Prior Allogeneic Stem Cell Transplant
• Diagnosis of acute promyelocytic leukemia
• Diagnosis of atypical chronic myeloid leukemia BCR-ABL1 negative, juvenile myelomonocytic leukemia, yelodysplastic/myeloproliferative neoplasm unclassifiable)
• Prior therapy with clofarabine at any dose
• Prior therapy with lenalidomide at doses greater than or equal to 25 milligrams daily
• Clinically significant active infection not responding adequately to therapy
• HIV Positive
• Uncontrolled concurrent hepatic, renal, cardiac, pulmonary, neurologic, infectious, or metabolic disease of such severity, which in the opinion of the PI, would preclude the subjects s ability to tolerate protocol therapy
• Ejection fraction less than 40% by Echocardiogram or MUGA
• Calculated creatinine clearance less 60 milliliters per minute
• Serum bilirubin greater than 1.5 times upper limit of normal
• Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) greater than 3 times upper limit normal
• Decreased oxygen saturation at rest (e.g. pulse oximeter less than 88% or PaO2 less than or equal to 55 millimeters of mercury)
• Patients with any condition that prevents their ability to swallow and retain lenalidomide tablets
• Severe psychiatric illness or complex social situations that would limit the patient s ability to tolerate and/or comply with study requirements
• Current pregnancy or breastfeeding

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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