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Dose-Ranging Study of Telintra® Tablets + Revlimid® in Patients With Non-Deletion (5q) Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

NCT01062152 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2013-06-06

No results posted yet for this study

Summary

This is an open label, multicenter Phase 1 dose escalation study evaluating five doses of ezatiostat in combination with lenalidomide in patients with non-del(5q) low to intermediate 1 risk MDS. The HI-E, HI-N, HI-P rates \[by International Working Group (IWG) 2006 criteria\] and safety of each treatment group will be evaluated to select the optimal dose of ezatiostat in combination with lenalidomide for future studies.

Conditions

Interventions

DRUG

Ezatiostat Hydrochloride

Starting dose 2000 mg orally in divided doses twice daily (1000 mg in AM \& 1000 mg in PM) x 21 days with one week off therapy in a 4-week cycle.

DRUG

Lenalidomide (Revlimid®)

10 mg orally per day in one AM dose x 21 days with one week off therapy in a 4-week cycle.

Sponsors & Collaborators

  • Telik

    lead INDUSTRY

Principal Investigators

  • Gail Brown, M.D. · Telik

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2012-11-30
Completion
2013-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01062152 on ClinicalTrials.gov