Study of Lenalidomide in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
The purpose of this study is to determine whether lenalidomide can stop the growth of leukemia stem cells and can be used to prevent the return of leukemia cells after a transplant.
Acute Myeloid Leukemia
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of Maintenance Lenalidomide in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome Post Allogeneic Bone Marrow Transplantation|
- Maximum-tolerated dose as assessed by NCI CTCAE, Version 4.0 and Graft versus Host Disease Staging [ Time Frame: 4 week cycle; the expected time frame is 24 weeks (or 6 cycles) ] [ Designated as safety issue: Yes ]All patients will be followed closely and evaluated for toxicity. For grade III-IV non hematological toxicity or grade IV hematological toxicity associated with lenalidomide will be held until the toxicity resolves and then will be started at a lower dose; Patients who develop grade II to IV GVHD on study will stop lenalidomide
- Disease relapse [ Time Frame: One year ] [ Designated as safety issue: Yes ]Percentage of patients with relapse from all the patients who received the transplant.
- Disease-free survival [ Time Frame: One year ] [ Designated as safety issue: No ]Percentage of patients who are alive and remain in remission at one year after infusion of stem cells
- Incidence of Graft versus Host disease [ Time Frame: One year ] [ Designated as safety issue: Yes ]The percentage of pathologically confirmed cases of acute and/or chronic Graft versus Host disease at one year post transplant
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: Phase I Dose Escalation
Subjects are given a single dose of the drug while they are observed and tested for a period of time. If they do not exhibit any adverse side effects the dose is escalated, and a new group of subjects is then given a higher dose.
Lenalidomide will be taken orally once a day for 21 days continuously in 28 day cycles. The dose of the lenalidomide administered to each patient will be based on the group that the patient is enrolled. The dose cycles will be 21 days of a 28 day cycle.
The purpose of this study is determine whether lenalidomide can directly inhibit leukemic stem cells in vivo and can be used to prevent the relapse of leukemia stem cells after transplant. A concern with any post transplant intervention is the possibility of multiple drug interactions, potential for graft versus host disease exacerbation and/or induction of cytopenia. Therefore, the smallest doses of lenalidomide (5 mg) that has been used in this setting will be utilized as dose level 1. Starting six months post-transplant, patients will begin on a daily dose of lenalidomide. Dependent on the cohort, patients will receive 5 to 20 mg of lenalidomide post transplant. The maximum tolerated dose (MTD) will be determined by the incidence of grade III-IV toxicities of all organs and grade II-IV GVHD. Duration of treatment is six months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433965
|Contact: Mehrdad Abedi, MDfirstname.lastname@example.org|
|United States, California|
|University of California Davis||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Corinne Turrell 916-734-3089|
|Principal Investigator: Mehrdad Abedi, MD|
|Principal Investigator:||Mehrdad Abedi, MD||University of California, Davis|