Dose-Ranging Study of Telintra® Tablets + Revlimid® in Patients With Non-Deletion (5q) Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
NCT ID: NCT01062152
Last Updated: 2013-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
19 participants
INTERVENTIONAL
2009-11-30
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Revlimid® in Combination with Telintra ®
Lenalidomide (Revlimid®) followed by Telintra® until MDS progression or lack of efficacy.
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.
Lenalidomide (Revlimid®)
10 mg orally per day in one AM dose x 21 days with one week off therapy in a 4-week cycle.
Interventions
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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.
Lenalidomide (Revlimid®)
10 mg orally per day in one AM dose x 21 days with one week off therapy in a 4-week cycle.
Eligibility Criteria
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Inclusion Criteria
* Non-del(5q) low or Intermediate-1risk MDS
* ECOG performance status of 0-1
* Documented significant cytopenia for at least 2 months
* Must have discontinued growth factors (EPO, G-CSF, GM-CSF) for at least 21 days prior to study entry
* All study participants must be registered into the mandatory RevAssist® program and be willing and able to comply with the requirements of RevAssist®
* Females of childbearing potential should have two negative serum pregnancy tests with a sensitivity of at least 50 mIU/mL. The first test should be performed within 10-14 days, and the second test within 24 hours of prescribing lenalidomide (prescriptions must be filled within seven days)
Exclusion Criteria
* Known prior therapy with or hypersensitivity to thalidomide or lenalidomide
* Prior allogenic bone marrow transplant for MDS
* History or prior malignancy
* Except for treated carcinoma of uterine cervix, basal cell or squamous cell skin cancer, or other cancers (e.g. breast, prostate) for which patient has been disease-free for at least 3 years.
* MDS evolving from:
* A pre-existing myeloproliferative disorder
* An autoimmune disease
* Secondary to prior treatment with radiation or chemotherapy
* History of MDS IPSS score\>1.0
* Pregnant or lactating women
* Leptomeningeal or leukemic meningitis
* Prior treatment with DNA methyltransferase inhibitors (DMTI) \[e.g., azacitadine, decitabine, etc.\]
18 Years
ALL
No
Sponsors
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Telik
INDUSTRY
Responsible Party
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Principal Investigators
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Gail Brown, M.D.
Role: STUDY_DIRECTOR
Telik
Locations
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Mayo Clinic
Phoenix, Arizona, United States
Loyola University Chicago Cardinal Benardin Cancer Center
Maywood, Illinois, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Columbia University Medical Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
MDAnderson
Houston, Texas, United States
Cancer Care Centers of South Texas
San Antonio, Texas, United States
Countries
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References
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Raza A, Galili N, Mulford D, Smith SE, Brown GL, Steensma DP, Lyons RM, Boccia R, Sekeres MA, Garcia-Manero G, Mesa RA. Phase 1 dose-ranging study of ezatiostat hydrochloride in combination with lenalidomide in patients with non-deletion (5q) low to intermediate-1 risk myelodysplastic syndrome (MDS). J Hematol Oncol. 2012 Apr 30;5:18. doi: 10.1186/1756-8722-5-18.
Other Identifiers
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TLK199.1104
Identifier Type: -
Identifier Source: org_study_id
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