Phase 2 Study Comparing Two Dose Schedules of Telintra™ in Myelodysplastic Syndrome (MDS)
Phase 2 Randomized Study Comparing Two Dose Schedules of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) in Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
1 other identifier
interventional
86
1 country
36
Brief Summary
This is a randomized, open label, multicenter, Phase 2 study comparing two dose schedules of Telintra in patients with Low or Intermediate-1 risk MDS. Patients at least 18 years of age presenting with histologically confirmed Low to Intermediate-1 risk MDS with documented significant cytopenia for at least two months by the IWG criteria are eligible.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2008
Typical duration for phase_2
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 13, 2008
CompletedFirst Posted
Study publicly available on registry
June 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedOctober 12, 2011
August 1, 2011
3.2 years
June 13, 2008
October 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hematologic Improvement-Erythroid (HI-E) rate
24 Weeks
Secondary Outcomes (1)
Hematologic Improvement-Neutrophil (HI-N) rate, the Hematologic Improvement-Platelet (HI-P) rate, overall hematologic response rate, safety profile and Quality of Life assessments.
24 Weeks
Study Arms (2)
1
EXPERIMENTALDose Schedule 1: Two weeks treatment with Telintra 3000 mg per day in two divided doses followed by one week with no treatment per three week cycle.
2
EXPERIMENTALDose Schedule 2: Three weeks treatment with Telintra 2000 mg per day in two divided doses followed by one week with no treatment per four week cycle.
Interventions
Dose Schedule 1-3000 mg orally per day in two divided doses for two weeks followed by 1 week with no treatment per three week cycle. Dose Schedule 2-2000 mg orally per day in two divided doses for three weeks followed by 1 week with no treatment per four week cycle.
Eligibility Criteria
You may qualify if:
- Primary or de novo MDS
- Low or intermediate-1 MDS
- ECOG performance status 0 or 1
- Documented significant anemia with or without neutropenia and/or thrombocytopenia
- Adequate kidney and liver function
- Patients must have discontinued hematopoietic growth factors at least 3 weeks prior to study entry
You may not qualify if:
- Prior allogenic bone marrow transplant for MDS
- History of MDS IPSS score greater than 1.0
- Pregnant or lactating women
- Any severe concurrent disease, infection, or comorbidity that, in the judgement of the investigator, would make the patient inappropriate for study entry
- Oral steroids e.g. prednisone \>10 mg per day
- History of active hepatitis B or C
- Known history of HIV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Teliklead
Study Sites (36)
Arizona Cancer Center
Tucson, Arizona, 85724-5024, United States
Central Hematology Oncology Medical Group, Inc.
Alhambra, California, 91801, United States
St. Jude Heritage Healthcare
Fullerton, California, 92835, United States
Wilshire Oncology Medical Group, Inc.
La Verne, California, 91750, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
Clinical Trials and Research Associates, Inc.
Montebello, California, 90640, United States
North Valley Hematology/Oncology Medical Group
Northridge, California, 91325, United States
Bay Area Cancer Research Group
Pleasant Hill, California, 94523, United States
Desert Hematology Oncology Medical Group
Rancho Mirage, California, 92270, United States
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, 92077, United States
Sansum Clinic
Santa Barbara, California, 93105, United States
Santa Barbara Hematology Medical Group, Inc.
Santa Barbara, California, 93105, United States
Central Coast Medical Oncology Corporation
Santa Maria, California, 93454, United States
University of Colorado at Denver Health Sciences Center
Aurora, Colorado, 80445, United States
The Center for Hematology Oncology
Boca Raton, Florida, 33486, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33805, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Northeast Georgia Cancer Care, LLC
Athens, Georgia, 30607, United States
Suburban Hematology-Oncology Associates, P.C.
Lawrenceville, Georgia, 30045, United States
Joliet Oncology-Hematology Associates, Ltd.
Joliet, Illinois, 60435, United States
Loyola University Chicago
Maywood, Illinois, 60153, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Central Hematology Oncology Medical Group, Inc.
Terre Haute, Indiana, 47802, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89052, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
St. Vincent's Comprehensive Cancer Center
New York, New York, 10011, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Case Western Reserve University/University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Hematology & Medical Oncology
Cleveland, Ohio, 44195, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Cancer Care Associates
Oklahoma City, Oklahoma, 73112, United States
Cancer Care Associates
Tulsa, Oklahoma, 74136, United States
Kaiser Permanente
Portland, Oregon, 97227, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Cancer Care Centers of South Texas
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gail Brown, MD
Telik
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2008
First Posted
June 18, 2008
Study Start
May 1, 2008
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
October 12, 2011
Record last verified: 2011-08