Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-30 @ 6:05 PM
Study NCT ID:
NCT00002832
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decitabine and Peripheral Stem Cell Transplantation in Treating Patients Who Have Relapsed Following Bone Marrow Transplantation for Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D015465', 'term': 'Leukemia, Myeloid, Accelerated Phase'}, {'id': 'D001752', 'term': 'Blast Crisis'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002471', 'term': 'Cell Transformation, Neoplastic'}, {'id': 'D063646', 'term': 'Carcinogenesis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D000077209', 'term': 'Decitabine'}, {'id': 'D033581', 'term': 'Stem Cell Transplantation'}, {'id': 'D036102', 'term': 'Peripheral Blood Stem Cell Transplantation'}], 'ancestors': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D018380', 'term': 'Hematopoietic Stem Cell Transplantation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1995-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2002-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-27', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-07-28', 'lastUpdatePostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD) Decitabine', 'timeFrame': 'Weekly for 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Decitabine', 'Dacogen', 'Filgrastim', 'G-CSF', 'Neupogen', 'Cyclosporine', 'Sandimmune', 'CYA', 'Cyclosporin A', 'Peripheral blood stem cells', 'PBSC', 'Allogeneic bone marrow transplantation', 'recurrent childhood acute lymphoblastic leukemia', 'recurrent childhood acute myeloid leukemia', 'recurrent adult acute myeloid leukemia', 'recurrent adult acute lymphoblastic leukemia', 'accelerated phase chronic myelogenous leukemia', 'blastic phase chronic myelogenous leukemia', 'previously treated myelodysplastic syndromes', 'childhood myelodysplastic syndromes'], 'conditions': ['Leukemia', 'Myelodysplastic Syndromes']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'UT MD Anderson Cancer Center website'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Peripheral stem cell transplantation may be an effective treatment for leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia that has relapsed following bone marrow transplantation.\n\nPURPOSE: Phase I/II trial to study the effectiveness of decitabine and peripheral stem cell transplantation in treating patients who have leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia that has relapsed after bone marrow transplantation.', 'detailedDescription': 'OBJECTIVES: I. Determine the maximum tolerated dose of decitabine in patients with relapse post allogenic bone marrow transplant. II. Determine the toxicity of decitabine combined with filgrastim (G-CSF) primed allogeneic peripheral blood stem cells in patients who relapsed within 1 year after allogeneic bone marrow transplantation. III. Determine the effectiveness in reinducing remission in these patients.\n\nOUTLINE: Patients receive decitabine IV for 6 hours every 12 hr for 5 days. Peripheral blood stem cells (PBSC) are administered 5 days after last dose of decitabine. Donors receive filgrastim subcutaneously (SQ) daily every 12 hours starting 2-4 days prior to first PBSC collection. If insufficient number of cells are collected, bone marrow can be harvested for supplementation. Donor cells should be collected prior to decitabine infusion. Patients receive filgrastim SQ administered daily starting 1 day after PBSC infusion until blood counts recover. For GVHD prophylaxis, patients receive cyclosporine IV daily on day -2, then orally once dose is tolerable. Dose of decitabine is escalated in cohorts of 3-6 patients. If dose limiting toxicity occurs in 2 of 6 patients at a given dose level, then that dose is declared the maximum tolerated dose. Patients are followed weekly. If none of the first 5 patients survive in remission for more than 100 days, the study will be terminated.\n\nPROJECTED ACCRUAL: At least 15 patients will be accrued for this study over 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Acute leukemia, myelodysplastic syndromes or chronic myelogenous leukemia (CML) in accelerated phase or blast crisis and relapsed within 1 year after allogeneic bone marrow transplantation Must not be candidates for second course of high dose chemoradiotherapy\n\nPATIENT CHARACTERISTICS: Age: 60 and under Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 3 mg/dL Renal: Creatinine less than 2 mg/dL Cardiovascular: Greater than 40% ejection fraction per MUGA scan or ECHO Other: Not pregnant No serious intercurrent illness No active CNS disease Must be ineligible for protocols of higher priority No active acute graft vs host disease (GVHD) greater than grade 2 or extensive chronic GVHD No active uncontrolled infection Original marrow donor must undergo filgrastim primed peripheral blood stem cell collection\n\nPRIOR CONCURRENT THERAPY: See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00002832', 'briefTitle': 'Decitabine and Peripheral Stem Cell Transplantation in Treating Patients Who Have Relapsed Following Bone Marrow Transplantation for Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Phase I/II Trial of Decitabine and Allogeneic Peripheral Blood Stem Cells Transplantation for Treatment of Relapse Post Allogeneic Bone Marrow Transplantation', 'orgStudyIdInfo': {'id': 'DM94-077'}, 'secondaryIdInfos': [{'id': 'P30CA016672', 'link': 'https://reporter.nih.gov/quickSearch/P30CA016672', 'type': 'NIH'}, {'id': 'MDA-DM-94077', 'type': 'OTHER', 'domain': 'UT MD Anderson Cancer Center'}, {'id': 'NCI-G96-1000'}, {'id': 'CDR0000065034', 'type': 'REGISTRY', 'domain': 'NCI PDQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Decitabine + Stem Cell Transplantation', 'interventionNames': ['Biological: Filgrastim', 'Drug: Cyclosporine', 'Drug: Decitabine', 'Procedure: Allogeneic Bone Marrow Transplantation', 'Procedure: Peripheral Blood Stem Cell Transplantation']}], 'interventions': [{'name': 'Filgrastim', 'type': 'BIOLOGICAL', 'otherNames': ['C-CSF', 'Neupogen'], 'description': 'Subcutaneously (SQ) daily every 12 hours starting 2-4 days prior to first PBSC collection then daily starting 1 day after PBSC infusion until blood counts recover.', 'armGroupLabels': ['Decitabine + Stem Cell Transplantation']}, {'name': 'Cyclosporine', 'type': 'DRUG', 'otherNames': ['Sandimmune', 'CYA', 'Cyclosporin A'], 'description': 'IV daily on day -2, then orally once dose is tolerable, dose may be escalated.', 'armGroupLabels': ['Decitabine + Stem Cell Transplantation']}, {'name': 'Decitabine', 'type': 'DRUG', 'otherNames': ['Dacogen'], 'description': 'IV for 6 hours every 12 hr for 5 days.', 'armGroupLabels': ['Decitabine + Stem Cell Transplantation']}, {'name': 'Allogeneic Bone Marrow Transplantation', 'type': 'PROCEDURE', 'otherNames': ['ASCT', 'Stem Cell Transplantation'], 'description': 'Stem cell infusion on Day 0.', 'armGroupLabels': ['Decitabine + Stem Cell Transplantation']}, {'name': 'Peripheral Blood Stem Cell Transplantation', 'type': 'PROCEDURE', 'otherNames': ['PBSC'], 'description': 'Peripheral blood stem cells (PBSC) are administered 5 days after last dose of decitabine.', 'armGroupLabels': ['Decitabine + Stem Cell Transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas - MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Sergio Giralt, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}