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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

Primary Purpose

Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

sargramostim

About this trial

This is an interventional supportive care trial for Chronic Myeloproliferative Disorders focused on measuring graft versus host disease, accelerated phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, primary myelofibrosis, childhood acute myeloid leukemia/other myeloid malignancies, childhood acute promyelocytic leukemia (M3), recurrent childhood acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia, recurrent childhood large cell lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent childhood small noncleaved cell lymphoma, recurrent/refractory childhood Hodgkin lymphoma, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, meningeal chronic myelogenous leukemia, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult diffuse small cleaved cell lymphoma, noncontiguous stage II adult Burkitt lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, noncontiguous stage II mantle cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult acute lymphoblastic leukemia, recurrent adult acute myeloid leukemia, recurrent adult Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, relapsing chronic myelogenous leukemia, secondary acute myeloid leukemia, refractory chronic lymphocytic leukemia, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult Burkitt lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III mantle cell lymphoma, stage III chronic lymphocytic leukemia, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult Burkitt lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV mantle cell lymphoma, stage IV chronic lymphocytic leukemia, untreated adult acute lymphoblastic leukemia, untreated adult acute myeloid leukemia, untreated childhood acute lymphoblastic leukemia, untreated childhood acute myeloid leukemia and other myeloid malignancies, childhood chronic myelogenous leukemia, chronic eosinophilic leukemia, chronic neutrophilic leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, myelodysplastic/myeloproliferative neoplasm, unclassifiable, noncontiguous stage II small lymphocytic lymphoma, noncontiguous stage II marginal zone lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage III marginal zone lymphoma, stage IV small lymphocytic lymphoma, stage IV marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(15;17)(q22;q12), childhood myelodysplastic syndromes

Eligibility Criteria

5 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Roswell Park Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00053157

First Posted

January 27, 2003

Last Updated

October 3, 2022

Sponsor

Roswell Park Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT00053157

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

June 2002 (undefined)

Primary Completion Date

August 2004 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Roswell Park Cancer Institute

4. Oversight

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia, Lymphoma, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

Keywords

graft versus host disease, accelerated phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, primary myelofibrosis, childhood acute myeloid leukemia/other myeloid malignancies, childhood acute promyelocytic leukemia (M3), recurrent childhood acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia, recurrent childhood large cell lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent childhood small noncleaved cell lymphoma, recurrent/refractory childhood Hodgkin lymphoma, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, meningeal chronic myelogenous leukemia, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult diffuse small cleaved cell lymphoma, noncontiguous stage II adult Burkitt lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, noncontiguous stage II mantle cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult acute lymphoblastic leukemia, recurrent adult acute myeloid leukemia, recurrent adult Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, relapsing chronic myelogenous leukemia, secondary acute myeloid leukemia, refractory chronic lymphocytic leukemia, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult Burkitt lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III mantle cell lymphoma, stage III chronic lymphocytic leukemia, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult Burkitt lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV mantle cell lymphoma, stage IV chronic lymphocytic leukemia, untreated adult acute lymphoblastic leukemia, untreated adult acute myeloid leukemia, untreated childhood acute lymphoblastic leukemia, untreated childhood acute myeloid leukemia and other myeloid malignancies, childhood chronic myelogenous leukemia, chronic eosinophilic leukemia, chronic neutrophilic leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, myelodysplastic/myeloproliferative neoplasm, unclassifiable, noncontiguous stage II small lymphocytic lymphoma, noncontiguous stage II marginal zone lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage III marginal zone lymphoma, stage IV small lymphocytic lymphoma, stage IV marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(15;17)(q22;q12), childhood myelodysplastic syndromes

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

sargramostim

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philip L. McCarthy, MD

Organizational Affiliation

Roswell Park Cancer Institute

Official's Role

Study Chair

Facility Information:

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263-0001

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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