Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-06 @ 1:48 PM
Study NCT ID:
NCT00534118
Status:
COMPLETED
Last Update Posted:
2020-08-26
First Post:
2007-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Donor Lymphocyte Infusion in Treating Patients With Recurrent or Persistent Hematologic Cancer After Donor Stem Cell Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D015465', 'term': 'Leukemia, Myeloid, Accelerated Phase'}, {'id': 'D015466', 'term': 'Leukemia, Myeloid, Chronic-Phase'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D016400', 'term': 'Lymphoma, Large-Cell, Immunoblastic'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D008258', 'term': 'Waldenstrom Macroglobulinemia'}, {'id': 'D054739', 'term': 'Dendritic Cell Sarcoma, Interdigitating'}, {'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}, {'id': 'D009182', 'term': 'Mycosis Fungoides'}, {'id': 'D012751', 'term': 'Sezary Syndrome'}], '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': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'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': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D015620', 'term': 'Histiocytic Disorders, Malignant'}, {'id': 'D015614', 'term': 'Histiocytosis'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'theresa.hahn@roswellpark.org', 'phone': '716-845-2300', 'title': 'Theresa Hahn', 'organization': 'Roswell Park Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'All cause mortality includes individual participants who experienced death due to any cause before 3 years after first DLI and is the only SAE/AE captured per protocol', 'description': 'All cause mortality includes individual participants who experienced death due to any cause before 3 years after first DLI', 'eventGroups': [{'id': 'EG000', 'title': 'Multiple DLI', 'description': 'Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 10, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Single DLI', 'description': 'accruals where the patient received only one donor lymphocyte infusion', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 7, 'seriousNumAffected': 7}], 'seriousEvents': [{'term': 'All cause mortality by 3 years after first DLI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Complete Remission Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multiple DLI', 'description': 'Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions'}, {'id': 'OG001', 'title': 'Single DLI', 'description': 'accruals where the patient received only one donor lymphocyte infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '100 days post DLI', 'description': 'continued or induced complete remission after DLI', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Each accrual is evaluable independently, some patients in both the Multiple and Single DLI are accrued more than once; total unique patients in multiple DLI is 15 and in single DLI is 12'}, {'type': 'PRIMARY', 'title': 'Duration of Complete Response in Months (Maximum 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multiple DLI - Complete Responders', 'description': 'Duration of time patients who achieved a complete remission by day +100 after DLI maintained that remission'}, {'id': 'OG001', 'title': 'Single DLI - Complete Responders', 'description': 'Duration of time patients who achieved a complete remission by day +100 after DLI maintained that remission'}], 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '12'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 year post DLI', 'description': 'For participants who achieve a complete remission after DLI, the duration of time until 1) relapse or 2) death in remission or 3) subsequent DLI or 4) last followup (at 1 year after DLI)', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Accruals which achieved a continued or induced complete remission at Day +100 after DLI, patients are censored at death in remission or at time of subsequent DLI'}, {'type': 'SECONDARY', 'title': 'Acute Graft-versus-host Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multiple DLI', 'description': 'Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions'}, {'id': 'OG001', 'title': 'Single DLI', 'description': 'accruals where the patient received only one donor lymphocyte infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '100 days post DLI', 'description': 'development of grade III-IV acute graft-versus-host disease (GVHD) per Glucksberg criteria', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Each accrual is evaluable for acute GVHD grade III-IV'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Multiple DLI', 'description': 'Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions'}, {'id': 'FG001', 'title': 'Single DLI', 'description': 'accruals where the patient received only one donor lymphocyte infusion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Multiple DLI', 'description': 'Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions'}, {'id': 'BG001', 'title': 'Single DLI', 'description': 'Accruals where the patient received only one donor lymphocyte infusion'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000', 'lowerLimit': '16', 'upperLimit': '66'}, {'value': '53.5', 'groupId': 'BG001', 'lowerLimit': '9', 'upperLimit': '68'}, {'value': '51', 'groupId': 'BG002', 'lowerLimit': '9', 'upperLimit': '68'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Disease', 'classes': [{'categories': [{'title': 'Acute Myeloid Leukemia', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Myelodysplastic Syndrome', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Non Hodgkin Leukemia', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Acute Lymphoblastic Leukemia', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Chronic Myeloid Leukemia', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Hodgkin Lymphoma', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Prolymphocytic Leukemia', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants can be accrued more than once; Accruals are based on the number of times the participant had a treatment (DLI) cycle that was evaluable (ie. \\>8 weeks between infusions per the protocol). DLIs which were given \\<8 weeks apart counted as one accrual.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-07', 'size': 4328657, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-07-29T13:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-21', 'studyFirstSubmitDate': '2007-09-20', 'resultsFirstSubmitDate': '2020-07-29', 'studyFirstSubmitQcDate': '2007-09-20', 'lastUpdatePostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-21', 'studyFirstPostDateStruct': {'date': '2007-09-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Remission Rate', 'timeFrame': '100 days post DLI', 'description': 'continued or induced complete remission after DLI'}, {'measure': 'Duration of Complete Response in Months (Maximum 12)', 'timeFrame': '1 year post DLI', 'description': 'For participants who achieve a complete remission after DLI, the duration of time until 1) relapse or 2) death in remission or 3) subsequent DLI or 4) last followup (at 1 year after DLI)'}], 'secondaryOutcomes': [{'measure': 'Acute Graft-versus-host Disease', 'timeFrame': '100 days post DLI', 'description': 'development of grade III-IV acute graft-versus-host disease (GVHD) per Glucksberg criteria'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['accelerated phase chronic myelogenous leukemia', 'chronic phase chronic myelogenous leukemia', 'relapsing chronic myelogenous leukemia', 'childhood chronic myelogenous leukemia', 'previously treated myelodysplastic syndromes', 'recurrent adult acute lymphoblastic leukemia', 'recurrent childhood acute lymphoblastic leukemia', 'adult acute myeloid leukemia with 11q23 (MLL) abnormalities', 'adult acute myeloid leukemia with inv(16)(p13;q22)', 'adult acute myeloid leukemia with t(15;17)(q22;q12)', 'adult acute myeloid leukemia with t(16;16)(p13;q22)', 'adult acute myeloid leukemia with t(8;21)(q22;q22)', 'recurrent adult acute myeloid leukemia', 'recurrent childhood acute myeloid leukemia', 'stage I multiple myeloma', 'stage II multiple myeloma', 'stage III multiple myeloma', 'refractory multiple myeloma', 'recurrent adult Hodgkin lymphoma', 'recurrent/refractory childhood Hodgkin lymphoma', 'recurrent adult Burkitt lymphoma', 'recurrent adult diffuse large cell lymphoma', 'recurrent adult diffuse mixed cell lymphoma', 'recurrent adult diffuse small cleaved cell lymphoma', 'recurrent adult immunoblastic large cell lymphoma', 'recurrent adult lymphoblastic lymphoma', 'recurrent grade 1 follicular lymphoma', 'recurrent grade 2 follicular lymphoma', 'recurrent grade 3 follicular lymphoma', 'recurrent mantle cell lymphoma', 'recurrent marginal zone lymphoma', 'recurrent small lymphocytic lymphoma', 'recurrent adult grade III lymphomatoid granulomatosis', 'Waldenstrom macroglobulinemia', 'recurrent childhood grade III lymphomatoid granulomatosis', 'recurrent childhood large cell lymphoma', 'recurrent childhood lymphoblastic lymphoma', 'childhood diffuse large cell lymphoma', 'childhood immunoblastic large cell lymphoma', 'recurrent childhood small noncleaved cell lymphoma', 'de novo myelodysplastic syndromes', 'secondary acute myeloid leukemia', 'secondary myelodysplastic syndromes', 'splenic marginal zone lymphoma', 'extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue', 'nodal marginal zone B-cell lymphoma', 'recurrent cutaneous T-cell non-Hodgkin lymphoma', 'recurrent mycosis fungoides/Sezary syndrome', 'cutaneous B-cell non-Hodgkin lymphoma'], 'conditions': ['Leukemia', 'Lymphoma', 'Multiple Myeloma and Plasma Cell Neoplasm', 'Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Giving an infusion of donor lymphocytes may be able to kill cancer cells in patients with hematologic cancer that has come back after a donor stem cell transplant.\n\nPURPOSE: This clinical trial is studying how well donor lymphocyte infusion works in treating patients with recurrent or persistent hematologic cancer after donor stem cell transplant.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine if the complete response rate exceeds 10% in patients with recurrent or persistent hematologic malignancies treated with donor lymphocyte infusion.\n\nSecondary\n\n* Estimate the complete response rate in these patients.\n* Assess the toxicity of donor lymphocyte infusion in these patients.\n\nOUTLINE: Patients receive up to four donor lymphocyte infusions at least 1 month apart in the absence of disease progression, unacceptable toxicity, or uncontrolled graft-versus-host disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '76 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Has undergone allogeneic stem cell transplantation (ASCT) for hematologic malignancy at least 30 days ago\n\n * No failure to engraft following transplant\n * No active acute or chronic graft-versus-host disease (GVHD)\n\n * Minimal GVHD allowed\n* Persistent or relapsed disease after ASCT, including 1 of the following:\n\n * Chronic myelogenous leukemia (CML), meeting any of the following criteria:\n\n * Molecular relapse (may be treated with imatinib mesylate after transplant), as defined by any of the following:\n\n * ASCT was non-T-cell depleted, a negative bcr/abl was documented by PCR post-transplant, and bcr/abl is now detectable by 2 consecutive PCR determinations \\> 30 days apart\n * ASCT was non-T-cell depleted and bcr/abl is detectable by PCR at any time after day 180 post-transplant\n * Cytogenetic relapse after 3-6 months of imatinib mesylate\n * Relapsed chronic phase, accelerated phase, or blastic phase CML after 3-6 months of imatinib mesylate\n\n * Must currently be in chronic phase or accelerated phase CML only\n * Patients with blastic phase CML must attain a second chronic phase\n * Acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndromes, meeting any of the following criteria:\n\n * Molecular relapse, as evidenced by \\< 5% blasts in the bone marrow and the patient's leukemia-specific molecular abnormality detectable by PCR\n * Cytogenetic relapse, as evidenced by \\< 5% blasts in the bone marrow and the patient's leukemia-specific chromosome abnormality detectable by standard cytogenetics at any time after day 60 post-transplant\n * Hematologic relapse, as evidenced by \\> 20% blasts in bone marrow or soft tissue recurrence\n\n * Must be treated with chemotherapy after transplant, but before study donor lymphocyte infusion (DLI)\n * Multiple myeloma\n\n * Relapsed disease or recurrence of M-protein after thalidomide or other salvage treatment\n\n * Prior post-transplant documentation of disappearance of M-protein by immunofixation\n * Residual or progressive disease\n * Rising M-protein level at any time post-transplant (measured at 3-month intervals)\n * Original M-protein detectable at 6 months post-transplant\n * Immune protein electrophoresis (IPEP) is required to show that M-component is the same on day 60 post-transplant as pre-transplant\n * Residual (\\> 5%) plasma cells in bone marrow\n * Relapsed non-Hodgkin lymphoma or Hodgkin lymphoma\n\n * Relapse or progression of disease must be evidenced within 3 months prior to donor lymphocyte infusion by physical exam, radiographic studies, or molecular studies\n\n * Tumor should be re-biopsied to determine histology\n * If Epstein-Barr virus (EBV) lymphoma is suspected, peripheral blood must be assayed for EBV genome (i.e., EBV DNA testing by PCR) within the past 30 days\n * EBV infection with associated pancytopenia\n\n * Persistent or refractory pancytopenia with EBV genome detected by PCR in the peripheral blood\n\n * Refractory pancytopenia is defined as pancytopenia that is poorly responsive to growth factors and/or transfusions\n * EBV lymphoproliferative disorder\n\n * Clonal lymphadenopathy that is refractory to standard therapy with acyclovir and immunoglobulin (DLI may be given with rituximab)\n* Not a candidate for repeat ASCT\n\n * Chimerism status is not required for determining eligibility for DLI\n* Patients eligible for allogeneic ASCT, but for whom DLI is offered as the first option, should have full donor chimerism at relapse or after therapy for relapsed disease\n* Patients with relapsed underlying disease after transplant who achieved remission after chemotherapy are allowed\n* No CNS recurrence that is not cleared by standard chemotherapy\n\n * CNS remission status must be maintained for 2 weeks\n* Original hematopoietic progenitor stem cell donor must be available for cell donation\n\n * No syngeneic donors\n\nPATIENT CHARACTERISTICS:\n\n* Karnofsky performance status 60-100%\n* Life expectancy ≥ 8 weeks\n* Creatinine \\< 3 mg/dL\n* ABO/Rh and CMV IgG/IgM status known\n* No HIV1 and HIV2 antibody\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 3 months (males) or 6 months (females) after completion of study treatment\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics"}, 'identificationModule': {'nctId': 'NCT00534118', 'briefTitle': 'Donor Lymphocyte Infusion in Treating Patients With Recurrent or Persistent Hematologic Cancer After Donor Stem Cell Transplant', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'Cellular Infusions in Patients With Recurrent or Persistent Hematologic Malignancies After Allogeneic Stem Cell Transplant', 'orgStudyIdInfo': {'id': 'CDR0000564827'}, 'secondaryIdInfos': [{'id': 'RPCI-I-00703'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Infusion', 'description': 'Patients receive up to four donor lymphocyte infusions at least 1 month apart in the absence of disease progression, unacceptable toxicity, or uncontrolled graft-versus-host disease', 'interventionNames': ['Biological: donor lymphocytes']}], 'interventions': [{'name': 'donor lymphocytes', 'type': 'BIOLOGICAL', 'description': 'Given IV', 'armGroupLabels': ['Infusion']}]}, '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': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Roswell Park Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}