MedTrace Logo

Combination of 5-azacitidine and Lenalidomide in Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML) Myelodysplastic Syndromes

NCT00923234 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2013-12-18

No results posted yet for this study

Summary

The hypothesis of this study is that 5-aza and lenalidomide act synergistically in MDS and AML patients with chromosomal abnormalities involving monosomy 5 or del5q. Therefore, this phase I study will investigate the maximum tolerated dose (MTD) of lenalidomide in combination with a fixed dose of 5-aza in this patient population.

Conditions

Interventions

DRUG

Azacitidine

75 mg/m² SC days 1-5 every 28 days for a maximum of 8 cycles

DRUG

Lenalidomide

10 - 25 mg PO days 6-19 every 28 days for a maximum of 8 cycles

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Technische Universität Dresden

    lead OTHER

Principal Investigators

  • Uwe Platzbecker, MD · Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Germany

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 NCT00923234 on ClinicalTrials.gov