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Azacitidine and Lenalidomide for Relapsed and Refractory Patients With Acute Myeloid Leukemia

NCT01743859 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2019-10-08

Study results available
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Summary

The primary objective of this study is to determine the complete remission/complete remission with incomplete recovery of blood counts (CR/CRi) rate for relapsed and refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) patients.

Conditions

Interventions

DRUG

Azacitidine

Enrolled patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone.

DRUG

Lenalidomide

Beginning on day 8, patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28.

OTHER

Off Therapy

2 weeks off therapy, then begin sequence again for 12 weeks.

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Daniel Pollyea, MD · University of Colorado, Denver

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-06
Primary Completion
2016-04-27
Completion
2016-08-03

Countries

  • United States

Study Locations

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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 NCT01743859 on ClinicalTrials.gov