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Biological Therapy in Treating Patients With Myelodysplastic Syndrome | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Biological Therapy in Treating Patients With Myelodysplastic Syndrome

Therapy of Myelodysplastic Syndrome (MDS) With Antithymocyte Globulin (ATG) and TNFR:Fc

NCT00005853•Fred Hutchinson Cancer Center

Summary

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of biological therapy in treating patients who have myelodysplastic syndrome.

Detailed Description

OBJECTIVES: * Determine the frequency of hematologic responses in patients with myelodysplastic syndrome treated with anti-thymocyte globulin and tumor necrosis factor receptor IgG chimera. * Correlate phenotypic, cytogenetic, and functional disease characteristics with treatment responses in these patients. * Determine the safety of this treatment regimen in this patient population. OUTLINE: Patients receive anti-thymocyte globulin IV over 8 hours daily for 4 days followed by tumor necrosis factor receptor IgG chimera subcutaneously twice weekly for 16 weeks. Patients are followed at 8, 16, and 20 weeks. PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•DISEASE CHARACTERISTICS:
•Diagnosis of myelodysplastic syndrome with no greater than 20% marrow blasts with:
•* Single or multilineage cytopenia (neutrophils less than 2,000/mm\^3 and/or platelet count less than 100,000/mm\^3 and/or reticulocyte count less than 18,000/mm\^3) OR
•* Transfusion requirement of at least 2 units packed red blood cells per month and one of the following:
•* Suitable marrow donor unavailable
•* Ineligible for a transplantation protocol
•* Unwilling to proceed with transplantation
•No chronic myelomonocytic leukemia
•PATIENT CHARACTERISTICS:
•Age:
+31 more criteria

Locations (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Key Dates

Start Date

December 1, 1999

Primary Completion Date

August 1, 2005

Completion Date

August 1, 2005

Last Updated

April 2, 2010

Conditions

LeukemiaMyelodysplastic Syndromes

Interventions

anti-thymocyte globulin

BIOLOGICAL

etanercept

BIOLOGICAL

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Biological Therapy in Treating Patients With Myelodysplastic Syndrome

Inclusion Criteria

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