Clinical trial NCT00700206: Phase 2 Study Comparing Two Dose Schedules of Telintra™ in Myelodysplastic Syndrome (MDS)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myelodysplastic Syndrome (MDS)
Keywords: 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
Lead sponsor: Telik
Sponsor class: INDUSTRY
First posted: 2008-06-18
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Hematologic Improvement-Erythroid (HI-E) rate
timeFrame: 24 Weeks
Secondary outcomes:
measure: Hematologic Improvement-Neutrophil (HI-N) rate, the Hematologic Improvement-Platelet (HI-P) rate, overall hematologic response rate, safety profile and Quality of Life assessments.
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Alhambra
country: United States
facility: Central Hematology Oncology Medical Group, Inc.
state: California
city: Fullerton
country: United States
facility: St. Jude Heritage Healthcare
state: California
city: La Verne
country: United States
facility: Wilshire Oncology Medical Group, Inc.
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Montebello
country: United States
facility: Clinical Trials and Research Associates, Inc.
state: California
city: Northridge
country: United States
facility: North Valley Hematology/Oncology Medical Group
state: California
city: Pleasant Hill
country: United States
facility: Bay Area Cancer Research Group
state: California
city: Rancho Mirage
country: United States
facility: Desert Hematology Oncology Medical Group
state: California
city: Redondo Beach
country: United States
facility: Cancer Care Associates Medical Group, Inc.
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Hematology Medical Group, Inc.
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology Corporation
state: California
city: Aurora
country: United States
facility: University of Colorado at Denver Health Sciences Center
state: Colorado
city: Boca Raton
country: United States
facility: The Center for Hematology Oncology
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Cancer Center
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Athens
country: United States
facility: Northeast Georgia Cancer Care, LLC
state: Georgia
city: Lawrenceville
country: United States
facility: Suburban Hematology-Oncology Associates, P.C.
state: Georgia
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates, Ltd.
state: Illinois
city: Maywood
country: United States
facility: Loyola University Chicago
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Terre Haute
country: United States
facility: Central Hematology Oncology Medical Group, Inc.
state: Indiana
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
city: New York
country: United States
facility: St. Vincent's Comprehensive Cancer Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Cleveland
country: United States
facility: Case Western Reserve University/University Hospitals of Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Hematology & Medical Oncology
state: Ohio
city: Oklahoma City
country: United States
facility: The University of Oklahoma Health Sciences Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Cancer Care Associates
state: Oklahoma
city: Tulsa
country: United States
facility: Cancer Care Associates
state: Oklahoma
city: Portland
country: United States
facility: Kaiser Permanente
state: Oregon
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Centers of South Texas
state: Texas
Study officials:
affiliation: Telik
name: Gail Brown, MD
role: STUDY_DIRECTOR
References: