Dose-Ranging Study of Telintra® Tablets + Revlimid® in Patients With Non-Deletion (5q) Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
Phase 1 Dose-Ranging Study of Ezatiostat Hydrochloride (Telintra®, TLK199 Tablets)in Combination With Lenalidomide (Revlimid®)in Patients With Non-Deletion(5q) Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
1 other identifier
interventional
19
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2009
Typical duration for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 2, 2010
CompletedFirst Posted
Study publicly available on registry
February 4, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedJune 6, 2013
June 1, 2013
3 years
February 2, 2010
June 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To establish the maximum tolerated dose (MTD) of ezatiostat in combination with lenalidomide
2 years
To determine the safety of ezatiostat in combination with lenalidomide
2 years
Secondary Outcomes (4)
To determine the efficacy of ezatiosate in combination wiht lenalidomide in patients with non-del(5q) low to intermediate-1 risk of MDS
2 years
Hematologic Improvement-Erythroid (HI-E) rate
2 years
Hematologic Improvement-Neutrophil (HI-N) rate
2 years
Hematologic Improvement-Platelet (HI-P) rate
2 years
Study Arms (1)
Revlimid® in Combination with Telintra ®
EXPERIMENTALLenalidomide (Revlimid®) followed by Telintra® until MDS progression or lack of efficacy.
Interventions
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.
10 mg orally per day in one AM dose x 21 days with one week off therapy in a 4-week cycle.
Eligibility Criteria
You may qualify if:
- Histologic diagnosis of primary or de novo MDS using WHO classification
- 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)
You may not qualify if:
- Known hypersensitivity to Telintra™ (intravenous or oral)
- 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) \[e.g., azacitadine, decitabine, etc.\]
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Teliklead
Study Sites (9)
Mayo Clinic
Phoenix, Arizona, 85054, United States
Loyola University Chicago Cardinal Benardin Cancer Center
Maywood, Illinois, 60153, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Columbia University Medical Center
New York, New York, 10032, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
MDAnderson
Houston, Texas, 77030, United States
Cancer Care Centers of South Texas
San Antonio, Texas, 78229, United States
Related Publications (1)
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.
PMID: 22546242DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gail Brown, M.D.
Telik
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2010
First Posted
February 4, 2010
Study Start
November 1, 2009
Primary Completion
November 1, 2012
Study Completion
March 1, 2013
Last Updated
June 6, 2013
Record last verified: 2013-06