NCT01578954

Lenalidomide as Consolidation and Maintenance in Adults >/= 60 Years of Age With AML Following Standard Induction

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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. 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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Lenalidomide	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

Timeline

• Start date: 2012-06-28
• Primary completion: 2016-05-18
• Completion: 2016-05-18
• First posted: 2012-04-17
• Last updated: 2022-01-27

Locations

1 site across 1 country: United States