Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-01-02 @ 10:08 AM
Study NCT ID:
NCT00053157
Status:
COMPLETED
Last Update Posted:
2022-10-05
First Post:
2003-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D054437', 'term': 'Myelodysplastic-Myeloproliferative Diseases'}, {'id': 'D015465', 'term': 'Leukemia, Myeloid, Accelerated Phase'}, {'id': 'D015466', 'term': 'Leukemia, Myeloid, Chronic-Phase'}, {'id': 'D055728', 'term': 'Primary Myelofibrosis'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D054739', 'term': 'Dendritic Cell Sarcoma, Interdigitating'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D016400', 'term': 'Lymphoma, Large-Cell, Immunoblastic'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'C580364', 'term': 'Pdgfra-Associated Chronic Eosinophilic Leukemia'}, {'id': 'D015467', 'term': 'Leukemia, Neutrophilic, Chronic'}, {'id': 'D054438', 'term': 'Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative'}, {'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D015620', 'term': 'Histiocytic Disorders, Malignant'}, {'id': 'D015614', 'term': 'Histiocytosis'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C081222', 'term': 'sargramostim'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'SUPPORTIVE_CARE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'lastUpdateSubmitDate': '2022-10-03', 'studyFirstSubmitDate': '2003-01-27', 'studyFirstSubmitQcDate': '2003-01-27', 'lastUpdatePostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-08', 'type': 'ACTUAL'}}, 'conditionsModule': {'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'], 'conditions': ['Chronic Myeloproliferative Disorders', 'Graft Versus Host Disease', 'Leukemia', 'Lymphoma', 'Myelodysplastic Syndromes', 'Myelodysplastic/Myeloproliferative Neoplasms']}, 'descriptionModule': {'briefSummary': "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.\n\nPURPOSE: 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.", 'detailedDescription': 'OBJECTIVES:\n\n* 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.\n* Determine the safety of GM-CSF after allogeneic SCT transplantation in these patients.\n\nOUTLINE: This is a pilot study.\n\n* Donors: Donors receive sargramostim (GM-CSF) subcutaneously (SC) once daily on days 1-6. Donors undergo stem cell harvest on day 7.\n\nDonors may undergo up to 3 apheresis procedures to reach the target stem cell dose and may receive additional GM-CSF prior to each collection.\n\n* 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.\n\nPatients are followed weekly until day 100 and then at days 180 and 360.\n\nPROJECTED ACCRUAL: A total of 10 patients and 10 donors will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Diagnosis of a malignant hematologic disease, including:\n\n * Acute or chronic leukemia\n * Myelodysplastic syndromes\n * Myeloproliferative disorder\n * Hodgkin's lymphoma\n * Non-Hodgkin's lymphoma OR\n* Aplastic anemia\n* Planned transplantation on an RPCI IRB-approved allogeneic stem cell transplantation protocol\n* HLA-matched (6/6) related donor available\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 5 to 60\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients and donors must use effective contraception\n* No known allergy to GM-CSF\n* No prior of adverse reaction to any yeast recombinant molecule\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* See Disease Characteristics\n* No prior allogeneic stem cell transplantation\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified"}, 'identificationModule': {'nctId': 'NCT00053157', 'briefTitle': 'Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic Anemia', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'RPC 02-01'}, 'secondaryIdInfos': [{'id': 'RPCI-RPC-0201'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'sargramostim', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263-0001', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Philip L. McCarthy, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Roswell Park Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}}}}