Study of Lenalidomide in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
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|ClinicalTrials.gov Identifier: NCT01433965|
Recruitment Status : Active, not recruiting
First Posted : September 14, 2011
Last Update Posted : May 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Myelodysplastic Syndrome||Drug: Lenalidomide||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Maintenance Lenalidomide in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome Post Allogeneic Bone Marrow Transplantation|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||December 2020|
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.
- 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) ]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 ]Percentage of patients with relapse from all the patients who received the transplant.
- Disease-free survival [ Time Frame: One year ]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 ]The percentage of pathologically confirmed cases of acute and/or chronic Graft versus Host disease at one year post transplant
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433965
|United States, California|
|University of California Davis|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Mehrdad Abedi, MD||University of California, Davis|