Erythropoietin (EPO)+/- Filgrastim (G-CSF) vs. Supportive Therapy Alone for Patients With Myelodysplastic Syndromes

Completed · Phase 3

Conditions studied: Anemia, Myelodysplastic Syndromes

In brief

RATIONALE: Erythropoietin and colony-stimulating factors such as filgrastim stimulate the production of blood cells. It is not yet known whether erythropoietin with or without filgrastim is more effective than standard blood transfusions in reducing the need for transfusions in patients who have anemia associated with myelodysplastic syndrome. PURPOSE: Randomized phase III trial to compare the effectiveness of erythropoietin with or without filgrastim with that of standard blood transfusions in reducing the need for transfusions in patients who have anemia associated with myelodysplastic syndrome.

Key facts

Study ID

NCT00003138

Run by

Eastern Cooperative Oncology Group

People needed

118

Starts

1998-03-04

Expected to finish

2014-05-01

Last updated by the study team

2023-06-29

Who can join

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

You may qualify if…

• At least 18 years of age
• Diagnosis of a myelodysplastic syndrome
• Refractory anemia (RA)
• RA with ringed sideroblasts
• RA with excess blasts (RAEB). RAEB patients must have a bone marrow blast count of less than 20% and less than 5% blast forms on peripheral blood
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 3
• Platelet count greater than 30,000/mm\^3 (without platelet transfusions)
• Hematocrit less than 30% (pretransfusion)
• Bilirubin less than 3 mg/dL
• Blood urea nitrogen (BUN) less than 40 mg/dL or Creatinine less than 2.0 mg/dL
• Prior epoetin alfa allowed provided dosage was less than 30,000 units per week for less than 1 month duration
• At least 1 month since prior erythropoietin
• At least 2 months since prior recombinant growth factor
• At least 2 months since prior chemotherapy for other malignancy or autoimmune disease
• At least 2 weeks since prior androgen or steroids for treatment of myelodysplastic syndromes

You may not qualify if…

• RAEB in transformation
• Chronic myelomonocytic leukemia
• Splenomegaly greater than 6 cm below the left costal margin or greater than 3 times normal size
• Uncontrolled hypertension
• Sensitivity to E. coli-derived proteins
• Sensitivity to epoetin alfa or any of its components (e.g., human albumin)
• Documented iron deficiency. If marrow iron stain is not available, the transferrin saturation must be greater than 20% or ferritin greater than 100 ng/dL
• Active infection or bleeding
• Other uncontrolled malignancy
• Pregnant or nursing. Fertile patients must use effective contraception.

Where it is running

• CCOP - Colorado Cancer Research Program, Incorporated — Denver, Colorado, United States
• Veterans Affairs Medical Center - Lakeside Chicago — Chicago, Illinois, United States
• Robert H. Lurie Comprehensive Cancer Center at Northwestern University — Chicago, Illinois, United States
• CCOP - Illinois Oncology Research Association — Peoria, Illinois, United States
• CCOP - Carle Cancer Center — Urbana, Illinois, United States
• CCOP - Cedar Rapids Oncology Project — Cedar Rapids, Iowa, United States
• CCOP - Iowa Oncology Research Association — Des Moines, Iowa, United States
• MBCCOP - LSU Health Sciences Center — New Orleans, Louisiana, United States
• Tufts - New England Medical Center — Boston, Massachusetts, United States
• CCOP - Michigan Cancer Research Consortium — Ann Arbor, Michigan, United States
• CCOP - Kalamazoo — Kalamazoo, Michigan, United States
• West Michigan Cancer Center — Kalamazoo, Michigan, United States
• CCOP - Metro-Minnesota — Saint Louis Park, Minnesota, United States
• CCOP - Missouri Valley Cancer Consortium — Omaha, Nebraska, United States
• CCOP - Southern Nevada Cancer Research Foundation — Las Vegas, Nevada, United States
• Veterans Affairs Medical Center - East Orange — East Orange, New Jersey, United States
• CCOP - Northern New Jersey — Hackensack, New Jersey, United States
• Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• NYU School of Medicine's Kaplan Comprehensive Cancer Center — New York, New York, United States
• CCOP - Merit Care Hospital — Fargo, North Dakota, United States
• MetroHealth's Cancer Care Center at MetroHealth Medical Center — Cleveland, Ohio, United States
• CCOP - Columbus — Columbus, Ohio, United States
• CCOP - Geisinger Clinic and Medical Center — Danville, Pennsylvania, United States
• CCOP - Sioux Community Cancer Consortium — Sioux Falls, South Dakota, United States
• CCOP - Scott and White Hospital — Temple, Texas, United States

Full record on ClinicalTrials.gov

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