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)

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.

Study Overview

• Status: Completed
• Conditions: Myelodysplastic Syndrome (MDS)
• Intervention / Treatment: Drug: Ezatiostat Hydrochloride

• Study Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hematologic Improvement-Erythroid (HI-E) rate	24 Weeks

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Telik
• Investigators: Study Director: Gail Brown, MD, Telik

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: June 13, 2008
• First Submitted That Met QC Criteria: June 13, 2008
• First Posted (Estimate): June 18, 2008

Study Record Updates

• Last Update Posted (Estimate): October 12, 2011
• Last Update Submitted That Met QC Criteria: October 10, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: MDS; Hematology; Myelodysplastic Syndrome; Glutathione; Low Risk MDS; Apoptosis; Differentiation; Intermediate-1 risk MDS; Int-1 risk MDS; Telintra; ezatiostat hydrochloride; ezatiostat; TLK199; Glutathione analog; Glutathione Transferase; Glutathione Transferase inhibitor; Glutathione Transferase P1-1 inhibitor; GSTp1-1 inhibitor; Enzyme inhibitor
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Syndrome; Myelodysplastic Syndromes; Preleukemia
• Other Study ID Numbers: TLK199.2101