DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Eastern Cooperative Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anemia; Myelodysplastic Syndromes

Intervention: Erythropoietin (Biological); Filgrastim (Biological); Transfusion (Procedure)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Eastern Cooperative Oncology Group

Official(s) and/or principal investigator(s):
Kenneth B. Miller, MD, Study Chair, Affiliation: Beth Israel Deaconess Medical Center

Summary

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.

Clinical Details

Official title: Phase III Evaluation of EPO With or Without G-CSF Versus Supportive Therapy Alone in the Treatment of Myelodysplastic Syndromes

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

Primary outcome: Proportion of Patients Free of Transfusion at 4 Months

Secondary outcome:

Overall Survival

Quality of Life- Total Functional Assessment of Cancer Therapy - General (FACT-G) Score at 4 Months

Detailed description: OBJECTIVES:

- Compare the benefit of erythropoietin vs standard transfusion support in reducing

transfusion requirements in patients with myelodysplastic syndromes.

- Compare the clinical response, disease progression, and survival in patients treated

with these regimens.

- Compare the toxicity of these regimens in these patients.

- Evaluate whether adding filgrastim (G-CSF) or increasing the erythropoietin dose will

reduce the transfusion requirement in patients who do not respond to erythropoietin alone.

- To compare the benefit of erythropoietin versus supportive care alone on quality of

life (QOL) in persons with myelodysplastic syndromes. OUTLINE: This is a randomized, controlled, multicenter, cross-over study. Patients are stratified according to morphologic subtype (refractory anemia [RA] vs RA with ringed sideroblasts vs RA with excess blasts), transfusion requirement (yes vs no), prior erythropoietin treatment (yes vs no), and erythropoietin level (at least 200 mU/mL vs less than 200 mU/mL). Patients are randomized to one of two treatment arms.

- Arm I (standard transfusion support): Patients receive red cell and platelet

transfusions for symptoms or to maintain hematocrit level of 25% or above. Patients undergo bone marrow aspirate and biopsy at 4 months and then every year until development of acute leukemia or completion of study. Patients with progressive disease may cross over to arm II after at least 4 months on study and up to 1 year from the time of randomization. Patients who cross over receive erythropoietin alone.

- Arm II (Erythropoietin): Patients receive erythropoietin subcutaneously (SC) or

intravenously (IV) daily. Patients undergo bone marrow aspirate and biopsy as in arm I. Treatment continues daily for a maximum of 1 year. Patients with stable or progressive disease at day 120 receive filgrastim (G-CSF) SC daily or 3 days a week and erythropoietin SC daily for up to 6 months. Patients with no response to G-CSF and lower-dose erythropoietin may proceed to a higher dose of erythropoietin. Quality of life is assessed at baseline, every 4 months during study, and at study completion. Patients are followed every 4 months for 2 years, every 6 months for 3 years, and then annually for 5 years. ACTUAL ACCRUAL: A total of 118 patients were accrued for this study.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Exclusion Criteria:

- 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.

Locations and Contacts

CCOP - Colorado Cancer Research Program, Incorporated, Denver, Colorado 80224, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois 60611, United States

Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois 60611-4494, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois 61602, United States

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States

CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa 52403-1206, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309-1016, United States

MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana 70112, United States

Tufts - New England Medical Center, Boston, Massachusetts 02111, United States

CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan 48106, United States

CCOP - Kalamazoo, Kalamazoo, Michigan 49007-3731, United States

West Michigan Cancer Center, Kalamazoo, Michigan 49007, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota 55416, United States

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68106, United States

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada 89106, United States

Veterans Affairs Medical Center - East Orange, East Orange, New Jersey 07019, United States

CCOP - Northern New Jersey, Hackensack, New Jersey 07601, United States

Cancer Institute of New Jersey, New Brunswick, New Jersey 08903, United States

NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York 10016, United States

CCOP - Merit Care Hospital, Fargo, North Dakota 58122, United States

MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio 44109, United States

CCOP - Columbus, Columbus, Ohio 43206, United States

CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania 17822-2001, United States

CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota 57104, United States

CCOP - Scott and White Hospital, Temple, Texas 76508, United States

CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin 54307-3453, United States

CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin 54449, United States

Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin 53226-3596, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Related publications:

Dewald G, Hicks G, Higgins RR, et al.: Comparison of interphase fish and metaphase cytogenetics to study myelodysplasia: an Eastern Cooperative Oncology Group (ECOG) study. [Abstract] Blood 96 (11 Pt 1): A-635, 148a, 2000.

Starting date: December 1997
Last updated: November 13, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017