Clinical Trial: Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia Who Have Undergone Stem Cell Transplant

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Phase I/II Study of Lenalidomide Maintenance After Autologous Stem Cell Transplant for Elderly Patients With Acute Myeloid Leukemia (AML)

Brief Summary: This phase I/II trial studies the side effects and best dose of lenalidomide and how well it works in treating older patients with acute myeloid leukemia who have undergone stem cell transplant. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine the safety and efficacy of maintenance lenalidomide post autologous peripheral blood stem cell transplantation (PBSCT) for elderly patients with acute myeloid leukemia (AML).

SECONDARY OBJECTIVES:

I. To define maximum tolerated dose (MTD) and establish therapeutic dose level (TDL) of lenalidomide given post autologous transplant for AML.

II. To determine the progression free survival for patients treated with this approach.

III. To determine the overall survival for patients treated with this approach. IV. To determine the role of residual AML stem cells on efficacy of lenalidomide maintenance after autologous PBSCT.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21. Courses repeat 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 6 months thereafter.


Sponsor: Albert Einstein College of Medicine, Inc.

Current Primary Outcome: Relapse free survival rate [ Time Frame: 2 years ]

The observed relapse free survival rate will be calculated along with its 95% confidence interval. A one sample test on proportion will be used to detect if the relapse free survival rate with lenalidomide is significantly higher than that without the treatment (relapse rate is expected to be > 95%).


Original Primary Outcome: Same as current

Current Secondary Outcome: Overall survival [ Time Frame: From transplant until death of any cause, assessed up to 4 years ]

Kaplan-Meier analysis will be conducted.


Original Secondary Outcome: Same as current

Information By: Albert Einstein College of Medicine, Inc.

Dates:
Date Received: January 15, 2014
Date Started: December 2013
Date Completion: January 2017
Last Updated: March 2, 2015
Last Verified: March 2015