Phase 2 Randomized Study Comparing Two Dose Schedules of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) in Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndrome (MDS)
Both
Myelodysplastic Syndrome (MDS)
Trial Information
Phase 2 Randomized Study Comparing Two Dose Schedules of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) in Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Hematologic Improvement-Erythroid (HI-E) rate
Outcome Time Frame:
24 Weeks
Safety Issue:
No
Principal Investigator
Gail Brown, MD
Investigator Role:
Study Director
Investigator Affiliation:
Telik
Authority:
United States: Food and Drug Administration
Study ID:
TLK199.2101
NCT ID:
NCT00700206
Start Date:
May 2008
Completion Date:
July 2011
Related Keywords:
- Myelodysplastic Syndrome (MDS)
- Hematology
- MDS
- Myelodysplastic Syndrome
- Low Risk MDS
- Intermediate-1 risk MDS
- Int-1 risk MDS
- Telintra
- ezatiostat hydrochloride
- ezatiostat
- TLK199
- Glutathione
- Glutathione analog
- Glutathione Transferase
- Glutathione Transferase inhibitor
- Glutathione Transferase P1-1 inhibitor
- GSTp1-1 inhibitor
- Apoptosis
- Differentiation
- Enzyme inhibitor
- Myelodysplastic Syndromes
- Preleukemia
Name | Location |
|---|---|
| Arizona Cancer Center | Tucson, Arizona 85724 |
| MD Anderson Cancer Center | Houston, Texas 77030-4096 |
| University of Rochester Medical Center | Rochester, New York 14642 |
| Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
| Southern Illinois University School of Medicine | Springfield, Illinois 62794-9658 |
| Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada 89109 |
| Wilshire Oncology Medical Group, Inc. | Rancho Cucamonga, California 91730 |
| St. Vincent's Comprehensive Cancer Center | New York, New York 10011 |
| Cancer Care Associates | Tulsa, Oklahoma 74136 |
| UCLA Medical Center | Los Angeles, California 90095-7059 |
| Lakeland Regional Cancer Center | Lakeland, Florida 33805 |
| Northeast Georgia Cancer Care, LLC | Athens, Georgia 30607 |
| North Valley Hematology/Oncology Medical Group | Northridge, California 91328 |
| Cancer Care Associates Medical Group, Inc. | Torrance, California 90505 |
| Moffitt Cancer Center | Tampa, Florida 33612 |
| Bay Area Cancer Research Group | Concord, California 94520 |
| Kaiser Permanente | Portland, Oregon 97227 |
| The University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
| Joliet Oncology-Hematology Associates, Ltd. | Flossmoor, Illinois 60422 |
| Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
| The Center for Hematology Oncology | Boca Raton, Florida 33486 |
| Clinical Trials and Research Associates, Inc. | Montebello, California 60460 |
| Central Hematology Oncology Medical Group, Inc. | Alhambra, California 91801 |
| Desert Hematology Oncology Medical Group | Rancho Mirage, California 92270 |
| Cancer Care Centers of South Texas | San Antonio, Texas 78229 |
| Central Coast Medical Oncology Corporation | Santa Maria, California 93454 |
| University of Colorado at Denver Health Sciences Center | Denver, Colorado 80045 |
| St. Jude Heritage Healthcare | Fullerton, California 92835 |
| Sansum Clinic | Santa Barbara, California 93105 |
| Santa Barbara Hematology Medical Group, Inc. | Santa Barbara, California 93105 |
| Suburban Hematology-Oncology Associates, P.C. | Lawrenceville, Georgia 30045 |
| Loyola University Chicago | Maywood, Illinois 60153 |
| Central Hematology Oncology Medical Group, Inc. | Terre Haute, Indiana 47802 |
| Hematology & Medical Oncology | Cleveland, Ohio 44195 |
| Case Western Reserve University/University Hospitals of Cleveland | Cleveland, Ohio 44106 |
