Phase I Study of Lenalidomide in Patients With Acute Leukemia
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|ClinicalTrials.gov Identifier: NCT01615042|
Recruitment Status : Terminated (Lack of enrollment)
First Posted : June 8, 2012
Last Update Posted : January 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Leukemia||Drug: Lenalidomide||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of High Dose Lenalidomide in Patients With Refractory/Relapsed Acute Leukemia as a Bridge to Bone Marrow Transplant|
|Actual Study Start Date :||August 2012|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||May 2017|
Experimental: Dose Escalation/High Dose Lenalidomide
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.
Oral capsule, daily, 50mg-100mg, one cycle (21 days)
Other Name: Revlimid
- Maximum Tolerated Dose (measured by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0) [ Time Frame: One Cycle (21 days) ]
All patients who receive the study drug will be followed closely and evaluated for toxicity.
Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE
- Rates of complete response (CR) and complete response without platelet recovery (CRi) [ Time Frame: One Cycle (21 days) ]Patients will be assessed for the efficacy (CR or CRi) if they have received at least 7 continuous days of study drug.
- Pharmacokinetics of high-dose lenalidomide cell activity. [ Time Frame: At 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dose on day 1, as well as before morning dosing on days 8, 15, and 21 during the clinical therapy ]Plasma concentrations of lenalidomide will be studied
- Define the effects of lenalidomide on T and Natural Killer (NK) cell activity. [ Time Frame: Baseline and at two weeks after therapy ]Blood samples will be drawn and will be tested for NK cell and T cell activity.
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): NCT01615042
|United States, California|
|University of California Comprehensive Cancer Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Mehrdad Abedi, MD||University of California, Davis|