Lenalidomide as Consolidation and Maintenance in Adults >/= 60 Years of Age With AML Following Standard Induction
The purpose of this research study is to test the safety of the study drug, lenalidomide, at different dose levels in people diagnosed with acute myeloid leukemia (AML) who have finished standard induction therapy and have had a partial or complete response to induction therapy. The investigators want to find out what effects (for example, side effects) the study drug, lenalidomide, has on people and their leukemia. The investigators also want to see if additional treatment (maintenance therapy) with lenalidomide will keep the leukemia from relapsing (coming back).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||LCCC 1111: An Open-Label Dose-Finding Study of Lenalidomide as Reinduction/ Consolidation Followed by Lenalidomide Maintenance Therapy for Adults ≥ 60 Years of Age With Acute Myeloid Leukemia (AML) in Partial or Complete Response Following Conventional Induction Therapy|
- Determine the rate of dose limiting toxicities. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Frequency of toxicity [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]Number of adverse events that occur during induction/consolidation.
- Duration of toxicity [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]Duration is measured by the length of time of a toxicity to resolve or return to baseline that occur during induction.
- Frequency of toxicity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Frequency will be measured as the number of individual toxicities that occur during maintenance.
- Response rates [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Response is based on the International Working Group to standardize response in AML.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Reinduction/Consolidation - dose escalation of lenalidomide: Level 1 - 25mg, Level 2 - 35mg, Level 3 - 50mg, PO, QD, 28 days.
Maintenance Lenalidomide - 10mg, PO, QD, continuous dosing, 12 months
Other Name: Revlimid
This study is a single-arm, open-label phase Ib clinical trial testing the hypothesis that the daily use of lenalidomide will be safe and tolerable as evidenced by the rate of dose-limiting toxicity (DLT) seen during one month of reinduction/consolidation in older (≥ 60 years of age) acute myeloid leukemia (AML) patients treated after one cycle of conventional, anthracycline-based induction. (Re-induction is the prescribed lenalidomide therapy given to patients who are in partial remission/response post induction while consolidation is the same prescribed lenalidomide therapy post induction given to patients who are in complete remission).
Dose escalation will take place within cohorts during the 28-day re-induction/ consolidation lenalidomide treatment at the University of North Carolina at Chapel Hill. After re-induction/consolidation, patients who harbor ≥ 5% peripheral blood or bone marrow myeloblasts will be removed from protocol therapy. Patients who have <5% peripheral blood or bone marrow myeloblasts after consolidation therapy will be allowed to continue to maintenance therapy: lenalidomide 10 mg/day continuously for up to 12 months. This trial will initially be restricted to UNC for enrollment.
Once dose escalation during re-induction/consolidation is complete, and all planned doses are tested for re-induction/consolidation, this trial may open to additional participating sites. Up to 26 patients will be enrolled.
This trial includes a Geriatric Assessment (GA) of each enrolled patient at baseline and serially across the trial. The investigators also plan to study natural killer (NK) cell phenotype and cytolytic function in patients at various intervals across the study (baseline, post re-induction/consolidation, and during maintenance.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578954
|Contact: Clinical Protocol Office||919-966-4432|
|United States, North Carolina|
|University of North Carolina at Chapel Hill - Lineberger Comprehensive Cancer Center||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Maureen Tynan, RN 919-843-7039 email@example.com|
|Principal Investigator: Matthew C Foster, MD|
|Principal Investigator:||Matthew C Foster, MD||UNC Lineberger Comprehensive Cancer Center|