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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Dose 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 | Experimental | Dose 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezatiostat Hydrochloride | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hematologic Improvement-Erythroid (HI-E) rate | 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail Brown, MD | Telik | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Cancer Center | Tucson | Arizona | 85724-5024 | United States | ||
| Central Hematology Oncology Medical Group, Inc. |
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|
|
| 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 |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C096329 | gamma-Glu-S-BzCys-PhGly diethyl ester |
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