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

Phase 2

Completed

• Conditions: Myelodysplastic Syndrome (MDS)
• Interventions: Drug: Ezatiostat Hydrochloride

• Registration Number: NCT00700206
• Lead Sponsor: Telik

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-13
• Study First Submitted QC: 2008-06-13
• Study First Posted: 2008-06-18
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2011-08
• Last Update Submitted: 2011-10-10
• Last Update Posted: 2011-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Ezatiostat Hydrochloride	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	Ezatiostat Hydrochloride	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.

Primary Outcome Measures

Name	Time	Method
Hematologic Improvement-Erythroid (HI-E) rate	24 Weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (34)

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

Central Hematology Oncology Medical Group, Inc.; 🇺🇸 Terre Haute, Indiana, United States

St. Jude Heritage Healthcare; 🇺🇸 Fullerton, California, United States

Wilshire Oncology Medical Group, Inc.; 🇺🇸 La Verne, California, United States

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Clinical Trials and Research Associates, Inc.; 🇺🇸 Montebello, California, United States

North Valley Hematology/Oncology Medical Group; 🇺🇸 Northridge, California, United States

Bay Area Cancer Research Group; 🇺🇸 Pleasant Hill, California, United States

Desert Hematology Oncology Medical Group; 🇺🇸 Rancho Mirage, California, United States

Cancer Care Associates Medical Group, Inc.; 🇺🇸 Redondo Beach, California, United States

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