Lenalidomide Plus Chemotherapy for AML

Status: Recruiting
Phase: Phase 1
Diagnosis: Leukemia/MDS
NCT ID: NCT01681537 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-202

 

This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational combination of drugs. Phase I studies also try to define the appropriate dose of the investigational combination of drugs to use for further studies. "Investigational" means that the combination of drugs is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved this combination of drugs for AML. As part of this research study, you will take lenalidomide in combination with MEC. MEC are FDA approved chemotherapy drugs that are commonly used in the treatment of AML. Lenalidomide is approved by the FDA for patients with multiple myeloma, and some patients with myelodysplasia. Lenalidomide is considered investigational in this research study because it is not approved by the FDA for patients with AML. Lenalidomide is a drug that affects the immune system, called an immunomodulatory drug or IMID. This drug is successful in the treatment of patients with multiple myeloma and some patients with myelodysplasia, a pre-leukemic condition. Other research studies suggest that lenalidomide may also be effective in patients with AML. Since we know that many patients who receive MEC chemotherapy alone do not have a prolonged remission (time free from leukemia), we are studying the addition of lenalidomide to MEC. In this research study, we are looking for the highest dose of lenalidomide that can be given safely with MEC.

 

Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center

Overall PI:
Karen Ballen, MD, Massachusetts General Hospital

Site-responsible Investigators:
Richard Stone, MD, Dana-Farber Cancer Institute
Katarina Luptakova, MD, Beth Israel Deaconess Medical Center

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Ilene Galinsky, 617-632-3902, igalinsky@partners.org

Eligibility Criteria

Inclusion Criteria: - Primary refractory disease following at least one cycle of induction therapy or first relapse or higher - Must be registered into RevAssist program - Able and willing to adhere to study schedule and other protocol requirements Exclusion Criteria: - Pregnant or breastfeeding - Known hypersensitivity to thalidomide or lenalidomide - Known seropositive for HIV - Have had myocardial infarction within 6 months of enrollment or NYHA Class III or IV heart failure - Other serious medical conditions or psychiatric conditions - Major surgery within 28 days prior to treatment - Received investigational agent or cytotoxic chemotherapy (except hydroxyurea) within 2 weeks of study - Acute promyelocytic leukemia
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