Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic Anemia

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Supportive care Completed 5 to 60 NCI RPCI-RPC-0201 NCT00053157

Objectives

1. Determine the efficacy of sargramostim (GM-CSF) to mobilize CD34+ hematopoietic stem cells in donors and to reduce graft-vs-host disease in patients after allogeneic stem cell transplantation (SCT) for hematologic malignancy or aplastic anemia.
2. Determine the safety of GM-CSF after allogeneic SCT transplantation in these patients.

Entry Criteria

Disease Characteristics:

• Diagnosis of a malignant hematologic disease, including:
  • Acute or chronic leukemia
  • Myelodysplastic syndromes
  • Myeloproliferative disorder
  • Hodgkin's lymphoma
  • Non-Hodgkin's lymphoma

  OR




• Aplastic anemia



• Planned transplantation on an RPCI IRB-approved allogeneic stem cell transplantation protocol



• HLA-matched (6/6) related donor available

Prior/Concurrent Therapy:

Biologic therapy

• See Disease Characteristics
• No prior allogeneic stem cell transplantation

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Patient Characteristics:

Age

• 5 to 60

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients and donors must use effective contraception
• No known allergy to GM-CSF
• No prior of adverse reaction to any yeast recombinant molecule

Expected Enrollment

A total of 10 patients and 10 donors will be accrued for this study.

Outline

This is a pilot study.

• Donors: Donors receive sargramostim (GM-CSF) subcutaneously (SC) once daily on days 1-6. Donors undergo stem cell harvest on day 7.

  Donors may undergo up to 3 apheresis procedures to reach the target stem cell dose and may receive additional GM-CSF prior to each collection.




• Patients: Patients receive conditioning therapy as per transplantation protocol RP98-15. Patients undergo allogeneic stem cell transplantation on day 0. Patients then receive GM-CSF SC once daily beginning on day 7 and continuing until blood counts recover.

Patients are followed weekly until day 100 and then at days 180 and 360.

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

Philip McCarthy, MD, Protocol chair		Ph: 716-845-4074; 800-685-6825 Email: philip.mccarthy@roswellpark.org

Registry Information
Official Title		Use Of Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) To Mobilize Donor Peripheral Blood Stem Cells Along With GM-CSF Administration Post Allogeneic Transplant - A Pilot Study
Trial Start Date		2002-06-18
Registered in ClinicalTrials.gov		NCT00053157
Date Submitted to PDQ		2002-11-26
Information Last Verified		2004-11-30
NCI Grant/Contract Number		P30-CA16056

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