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

Myelodysplastic Syndrome (MDS) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700206
• Other study ID #: TLK199.2101
• Status: Completed
• Phase: Phase 2
• First received: June 13, 2008
• Last updated: October 10, 2011
• Start date: May 2008
• Est. completion date: July 2011

Study information

• Verified date: August 2011
• Source: Telik
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myelodysplastic Syndrome (MDS)
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Central Hematology Oncology Medical Group, Inc.	Alhambra	California
United States	Northeast Georgia Cancer Care, LLC	Athens	Georgia
United States	University of Colorado at Denver Health Sciences Center	Aurora	Colorado
United States	Center for Cancer and Blood Disorders	Bethesda	Maryland
United States	The Center for Hematology Oncology	Boca Raton	Florida
United States	Case Western Reserve University/University Hospitals of Cleveland	Cleveland	Ohio
United States	Hematology & Medical Oncology	Cleveland	Ohio
United States	St. Jude Heritage Healthcare	Fullerton	California
United States	Comprehensive Cancer Centers of Nevada	Henderson	Nevada
United States	MD Anderson Cancer Center	Houston	Texas
United States	Joliet Oncology-Hematology Associates, Ltd.	Joliet	Illinois
United States	Wilshire Oncology Medical Group, Inc.	La Verne	California
United States	Lakeland Regional Cancer Center	Lakeland	Florida
United States	Suburban Hematology-Oncology Associates, P.C.	Lawrenceville	Georgia
United States	UCLA Medical Center	Los Angeles	California
United States	Loyola University Chicago	Maywood	Illinois
United States	Clinical Trials and Research Associates, Inc.	Montebello	California
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	St. Vincent's Comprehensive Cancer Center	New York	New York
United States	North Valley Hematology/Oncology Medical Group	Northridge	California
United States	Cancer Care Associates	Oklahoma City	Oklahoma
United States	The University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Bay Area Cancer Research Group	Pleasant Hill	California
United States	Kaiser Permanente	Portland	Oregon
United States	Desert Hematology Oncology Medical Group	Rancho Mirage	California
United States	Cancer Care Associates Medical Group, Inc.	Redondo Beach	California
United States	University of Rochester Medical Center	Rochester	New York
United States	Cancer Care Centers of South Texas	San Antonio	Texas
United States	Sansum Clinic	Santa Barbara	California
United States	Santa Barbara Hematology Medical Group, Inc.	Santa Barbara	California
United States	Central Coast Medical Oncology Corporation	Santa Maria	California
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	Moffitt Cancer Center	Tampa	Florida
United States	Central Hematology Oncology Medical Group, Inc.	Terre Haute	Indiana
United States	Arizona Cancer Center	Tucson	Arizona
United States	Cancer Care Associates	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Telik

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematologic Improvement-Erythroid (HI-E) rate		24 Weeks	No
Secondary	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	No