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Idarubicin + Cytarabine and Lenalidomide in Patients With Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML)

NCT00831766 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2020-12-22

Study results available
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Summary

The purpose of this study is to:

* Test the safety of the research study drug, lenalidomide, when given with Idarubicin and Cytarabine
* See how many respond to combination treatment with lenalidomide, Idarubicin and Cytarabine
* See how long people respond to this combination therapy
* See how long people live after being treated with this combination of drugs

Conditions

Interventions

DRUG

Idarubicin

Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.

DRUG

Cytarabine

Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.

DRUG

Lenalidomide (Revlimid®)

Lenalidomide as outlined in Phase I and Phase II Treatment Arms.

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Jeffrey Lancet, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-25
Primary Completion
2015-02-17
Completion
2020-11-16

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 NCT00831766 on ClinicalTrials.gov