NCT02126553

Lenalidomide in Treating Patients With High Risk Acute Myeloid Leukemia in Remission

Phase II Study of Lenalidomide Maintenance in Patients With High Risk AML in Remission

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well lenalidomide works in treating patients with acute myeloid leukemia that have had a decrease in or disappearance of signs and symptoms of cancer, although cancer still may be in the body and may be likely to come back or spread. Biological therapies, such as lenalidomide, use substances made from living organisms that may kill cancer cells by blocking blood flow to the cancer and by stimulating white blood cells to kill the cancer cells.

Detailed description

PRIMARY OBJECTIVE: I. To assess relapse-free survival (RFS) of patients with acute myeloid leukemia (AML) treated with lenalidomide maintenance therapy after achieving remission. SECONDARY OBJECTIVES: I. To assess overall survival (OS) of patients with AML treated with lenalidomide maintenance. II. To assess event-free survival (EFS) of patients with AML treated with lenalidomide maintenance. III. To assess the duration of remission (CRd) of patients with AML treated with lenalidomide maintenance. IV. To assess toxicity and safety of lenalidomide maintenance in patients with AML. V. To assess the effects of lenalidomide maintenance on natural killer (NK) cell modulation and dynamics of minimal residual disease and their relationship to outcomes. OUTLINE: Patients receive lenalidomide orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6-12 months.

Conditions

• Alkylating Agent-Related Acute Myeloid Leukemia
• Secondary Acute Myeloid Leukemia

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Lenalidomide	Given PO

Timeline

• Start date: 2014-11-13
• Primary completion: 2021-11-30
• Completion: 2021-11-30
• First posted: 2014-04-30
• Last updated: 2022-11-14
• Results posted: 2022-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study