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

Information source: Roswell Park Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Myeloproliferative Disorders; Graft Versus Host Disease; Leukemia; Lymphoma; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms

Intervention: sargramostim (Biological)

Phase: N/A

Status: Completed

Sponsored by: Roswell Park Cancer Institute

Official(s) and/or principal investigator(s):
Philip L. McCarthy, MD, Study Chair, Affiliation: Roswell Park Cancer Institute

Summary

RATIONALE: Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy or radiation therapy. Giving sargramostim to the stem cell donor and the patient may reduce the chance of developing graft-versus-host disease following stem cell transplantation. PURPOSE: Clinical trial to study the effectiveness of sargramostim in decreasing graft-versus-host disease in patients who are undergoing donor stem cell transplantation for hematologic cancer or aplastic anemia.

Clinical Details

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

Study design: Primary Purpose: Supportive Care

Detailed description: OBJECTIVES:

- 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.

- Determine the safety of GM-CSF after allogeneic SCT transplantation in these patients.

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

Eligibility

Minimum age: 5 Years. Maximum age: 60 Years. Gender(s): Both.

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

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

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

Locations and Contacts

Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States
Additional Information

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

Starting date: June 2002
Last updated: January 30, 2013

Page last updated: August 23, 2015

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