MedTrace Logo

5-Azacytidine With Lenalidomide in Patients With High Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)

NCT01038635 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2017-02-10

Study results available
· View outcomes & findings →

Summary

The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of lenalidomide that can be given in combination with azacitidine to patients with MDS or AML.

The goal of Phase 2 of this study is to learn if the combination dose of azacitidine and lenalidomide found in Phase 1 can help to control MDS and/or AML.

The safety of this drug combination will be studied in both Phases.

Conditions

Interventions

DRUG

5-Azacytidine

75 mg/m\^2 IV daily x 5 days on days 1 to 5.

DRUG

Lenalidomide

Starting dose 10 mg orally daily x 5 days on days 6 to 10.

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Guillermo Garcia-Manero, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2015-11-30
Completion
2015-11-30

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 NCT01038635 on ClinicalTrials.gov