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

Completed · Phase 2

Conditions studied: Myelodysplastic Syndrome (MDS)

In brief

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.

Key facts

Study ID

NCT00700206

Run by

Telik

People needed

86

Starts

2008-05-01

Expected to finish

2011-07-01

Last updated by the study team

2011-10-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Cancer Center — Tucson, Arizona, United States
• Central Hematology Oncology Medical Group, Inc. — Alhambra, California, 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
• 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
• University of Colorado at Denver Health Sciences Center — Aurora, Colorado, United States
• The Center for Hematology Oncology — Boca Raton, Florida, United States
• Lakeland Regional Cancer Center — Lakeland, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Northeast Georgia Cancer Care, LLC — Athens, Georgia, United States
• Suburban Hematology-Oncology Associates, P.C. — Lawrenceville, Georgia, United States
• Joliet Oncology-Hematology Associates, Ltd. — Joliet, Illinois, United States
• Loyola University Chicago — Maywood, Illinois, United States
• Southern Illinois University School of Medicine — Springfield, Illinois, United States
• Central Hematology Oncology Medical Group, Inc. — Terre Haute, Indiana, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• Comprehensive Cancer Centers of Nevada — Henderson, Nevada, United States

Full record on ClinicalTrials.gov

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