A Trial of Lenalidomide & Azacitidine in Low Risk Myelodysplastic Syndromes

Stopped early · Phase 2

Conditions studied: MDS

In brief

This phase II study will evaluate the safety and efficacy of combining two active agents;Revlimid® (lenalidomide) and low dose Vidaza® (azacitidine) for the treatment of patients with low to intermediate-1 MDS excluding patients with 5 q deletion. The rationale for adding Vidaza® (azacitidine) after 3 months of revlimid monotherapy is that combination therapy will result in higher response rates, and potentially longer response duration than that achieved with either agent. STUDY OBJECTIVES: Primary: To determine the safety and tolerability of the combination of Revlimid® (lenalidomide) and low dose Vidaza® (azacitidine) in patients with low - intermediate-1 risk MDS non 5 q deletion who have not responded after 3 months of Revlimid® (lenalidomide) monotherapy Secondary: To determine the response rate in patients with low - intermediate-1 risk MDS non 5 q deletion receiving Revlimid® (lenalidomide) in combination with low dose Vidaza® (azacitidine), as defined by the IWG 2006 Revised Response Criteria

Key facts

Study ID

NCT01379274

Run by

Rush University Medical Center

People needed

2

Starts

2011-01-01

Expected to finish

2013-11-01

Last updated by the study team

2020-11-19

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• Pregnant or breast feeding females. Lactating females must agree not to breast feed while taking Revlimid® (lenalidomide).
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
• Use of any other experimental drug or therapy within 28 days of baseline.
• Known hypersensitivity to lenalidomide, azacitidine, or mannitol.
• Any prior use of Vidaza® (azacitidine).
• Prior use of Revlimid® (lenalidomide) for more than 84 days (three 28 day cycles).
• Concurrent use of other anti-cancer agents or treatments.
• Known positive for HIV or infectious hepatitis, type B or C.

Where it is running

• Rush University Medical Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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