Phase 2 Study Comparing Two Dose Schedules of Telintra™ in Myelodysplastic Syndrome (MDS) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Myelodysplastic Syndrome (MDS)	Drug: Ezatiostat Hydrochloride	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase 2 Randomized Study Comparing Two Dose Schedules of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) in Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

Resource links provided by NLM:

MedlinePlus related topics: Myelodysplastic Syndromes

Genetic and Rare Diseases Information Center resources: Myelodysplastic Syndromes

U.S. FDA Resources

Further study details as provided by Telik:

Primary Outcome Measures:

Hematologic Improvement-Erythroid (HI-E) rate [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hematologic Improvement-Neutrophil (HI-N) rate, the Hematologic Improvement-Platelet (HI-P) rate, overall hematologic response rate, safety profile and Quality of Life assessments. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]


Estimated Enrollment:	86
Study Start Date:	May 2008
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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.	Drug: Ezatiostat Hydrochloride 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. Other Names: Telintra ezatiostat tablets
Experimental: 2 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.	Drug: Ezatiostat Hydrochloride 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. Other Names: Telintra ezatiostat tablets

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700206

Hide Study Locations

Locations


United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724-5024
United States, California
Central Hematology Oncology Medical Group, Inc.
Alhambra, California, United States, 91801
St. Jude Heritage Healthcare
Fullerton, California, United States, 92835
Wilshire Oncology Medical Group, Inc.
La Verne, California, United States, 91750
UCLA Medical Center
Los Angeles, California, United States, 90095
Clinical Trials and Research Associates, Inc.
Montebello, California, United States, 90640
North Valley Hematology/Oncology Medical Group
Northridge, California, United States, 91325
Bay Area Cancer Research Group
Pleasant Hill, California, United States, 94523
Desert Hematology Oncology Medical Group
Rancho Mirage, California, United States, 92270
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, United States, 92077
Sansum Clinic
Santa Barbara, California, United States, 93105
Santa Barbara Hematology Medical Group, Inc.
Santa Barbara, California, United States, 93105
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
United States, Colorado
University of Colorado at Denver Health Sciences Center
Aurora, Colorado, United States, 80445
United States, Florida
The Center for Hematology Oncology
Boca Raton, Florida, United States, 33486
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33805
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Northeast Georgia Cancer Care, LLC
Athens, Georgia, United States, 30607
Suburban Hematology-Oncology Associates, P.C.
Lawrenceville, Georgia, United States, 30045
United States, Illinois
Joliet Oncology-Hematology Associates, Ltd.
Joliet, Illinois, United States, 60435
Loyola University Chicago
Maywood, Illinois, United States, 60153
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
United States, Indiana
Central Hematology Oncology Medical Group, Inc.
Terre Haute, Indiana, United States, 47802
United States, Maryland
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
United States, Nevada
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89052
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, New York
St. Vincent's Comprehensive Cancer Center
New York, New York, United States, 10011
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Ohio
Case Western Reserve University/University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Hematology & Medical Oncology
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Cancer Care Associates
Oklahoma City, Oklahoma, United States, 73112
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Cancer Care Associates
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Kaiser Permanente
Portland, Oregon, United States, 97227
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Telik

Investigators


Study Director:	Gail Brown, MD	Telik

More Information

No publications provided


Responsible Party:	Telik
ClinicalTrials.gov Identifier:	NCT00700206 History of Changes
Other Study ID Numbers:	TLK199.2101
Study First Received:	June 13, 2008
Last Updated:	October 10, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Telik:


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

Additional relevant MeSH terms:


Myelodysplastic Syndromes Preleukemia Bone Marrow Diseases	Hematologic Diseases Neoplasms Precancerous Conditions

ClinicalTrials.gov processed this record on March 03, 2015