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

NCT01578954 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-01-27

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Matthew C Foster, MD · UNC Lineberger Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-28
Primary Completion
2016-05-18
Completion
2016-05-18

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01578954 on ClinicalTrials.gov