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
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the rate of dose limiting toxicities.
28 days
Yes
Matthew C Foster, MD
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
United States: Food and Drug Administration
LCCC 1111
NCT01578954
June 2012
January 2016
Name | Location |
---|---|
University of North Carolina at Chapel Hill - Lineberger Comprehensive Cancer Center | Chapel Hill, North Carolina 27599 |