Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2026-01-28 @ 12:56 PM
Study NCT ID:
NCT03272633
Status:
TERMINATED
Last Update Posted:
2023-06-26
First Post:
2017-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'C538045', 'term': 'Chromosome 17 deletion'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'id': 'D018365', 'term': 'Neoplasm, Residual'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'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': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'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': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'strairrk@cinj.rutgers.edu', 'phone': '732-235-4523', 'title': 'Roger K. Strair, MD', 'organization': 'Cancer Institute of New Jersey Rutgers'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 8 weeks after last protocol treatment', 'description': 'no data was collected. Adverse Events Description text only refers to the Cohort II No participants were enrolled in Cohort I, so no adverse events were monitored/assessed for Cohort I', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort I (Initial IHC Within 42 Days)', 'description': 'Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Receive IHC\n\nIrradiated Allogeneic Cells: Correlative studies', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort II (Initial IHC Within 70 Days or After Relapse)', 'description': 'Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Receive IHC\n\nIrradiated Allogeneic Cells: Correlative studies', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolism and nutrition disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervous system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Musculoskeletal and connective tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Received Irradiated Haploidentical Cells (IHC) With Disease Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I (Initial IHC Within 42 Days)', 'description': 'Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Receive IHC\n\nIrradiated Allogeneic Cells: Correlative studies'}, {'id': 'OG001', 'title': 'Cohort II (Initial IHC Within 70 Days or After Relapse)', 'description': 'Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Receive IHC\n\nIrradiated Allogeneic Cells: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 8 weeks after last protocol treatment', 'description': 'Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'no data was collected. Refers to the Cohort 1 Arm'}, {'type': 'PRIMARY', 'title': 'the Number of Participants With Toxicities Associated With Administration of Irradiated Haploidentical Cells (IHC) Evaluated According to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I (Initial IHC Within 42 Days)', 'description': 'Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Receive IHC\n\nIrradiated Allogeneic Cells: Correlative studies'}, {'id': 'OG001', 'title': 'Cohort II (Initial IHC Within 70 Days or After Relapse)', 'description': 'Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Receive IHC\n\nIrradiated Allogeneic Cells: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 weeks of completion of therapy', 'description': 'The anticipated/projected IHC-associated toxicities of greatest concern include: short-term toxicities- constitutional/systemic adverse events including fevers, hypotension, pulmonary infiltrates; long-term toxicities: autoimmune effects, graft-versus-host disease (GVHD), graft rejection. Toxicity will be measured by occurrence of any experimental treatment-related adverse events (AE) up to 12 weeks of completion of therapy. The CTCAE version 4.0 will be utilized for the description and grading of the AE. All symptoms, signs, or diseases assessed as experimental treatment-related will be captu', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'no data was collected. Refers to the Cohort 1 Arm'}, {'type': 'SECONDARY', 'title': 'Induction of Host T Cells Reactive With Tumor Associated Epitopes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I (Initial IHC Within 42 Days)', 'description': 'Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Receive IHC\n\nIrradiated Allogeneic Cells: Correlative studies'}, {'id': 'OG001', 'title': 'Cohort II (Initial IHC Within 70 Days or After Relapse)', 'description': 'Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Receive IHC\n\nIrradiated Allogeneic Cells: Correlative studies'}], 'timeFrame': 'Up to 8 weeks after last protocol treatment', 'description': 'It will be determined if treatment with the irradiated cells induces an immune response targeting tumor associated epitopes.', 'reportingStatus': 'POSTED', 'populationDescription': 'no data was collected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort I (Initial IHC Within 42 Days)', 'description': 'Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Receive IHC\n\nIrradiated Allogeneic Cells: Correlative studies'}, {'id': 'FG001', 'title': 'Cohort II (Initial IHC Within 70 Days or After Relapse)', 'description': 'Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Receive IHC\n\nIrradiated Allogeneic Cells: Correlative studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort I (Initial IHC Within 42 Days)', 'description': 'Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Receive IHC\n\nIrradiated Allogeneic Cells: Correlative studies'}, {'id': 'BG001', 'title': 'Cohort II (Initial IHC Within 70 Days or After Relapse)', 'description': 'Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Receive IHC\n\nIrradiated Allogeneic Cells: Correlative studies'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', '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': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'No participants qualified for cohort I'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-23', 'size': 11605725, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-28T17:04', 'hasProtocol': True}, {'date': '2021-04-23', 'size': 1281809, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-02-22T14:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Lack of enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-23', 'studyFirstSubmitDate': '2017-08-24', 'resultsFirstSubmitDate': '2023-03-20', 'studyFirstSubmitQcDate': '2017-09-01', 'lastUpdatePostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-23', 'studyFirstPostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Received Irradiated Haploidentical Cells (IHC) With Disease Response', 'timeFrame': 'Up to 8 weeks after last protocol treatment', 'description': 'Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR'}, {'measure': 'the Number of Participants With Toxicities Associated With Administration of Irradiated Haploidentical Cells (IHC) Evaluated According to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0', 'timeFrame': 'Up to 12 weeks of completion of therapy', 'description': 'The anticipated/projected IHC-associated toxicities of greatest concern include: short-term toxicities- constitutional/systemic adverse events including fevers, hypotension, pulmonary infiltrates; long-term toxicities: autoimmune effects, graft-versus-host disease (GVHD), graft rejection. Toxicity will be measured by occurrence of any experimental treatment-related adverse events (AE) up to 12 weeks of completion of therapy. The CTCAE version 4.0 will be utilized for the description and grading of the AE. All symptoms, signs, or diseases assessed as experimental treatment-related will be captu'}], 'secondaryOutcomes': [{'measure': 'Induction of Host T Cells Reactive With Tumor Associated Epitopes', 'timeFrame': 'Up to 8 weeks after last protocol treatment', 'description': 'It will be determined if treatment with the irradiated cells induces an immune response targeting tumor associated epitopes.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Lymphoblastic Leukemia', 'Acute Myeloid Leukemia in Remission', 'Hematopoietic Cell Transplantation Recipient', 'JAK2 Gene Mutation', 'Loss of Chromosome 17p', 'Mantle Cell Lymphoma', 'Minimal Residual Disease', 'Myelodysplastic Syndrome', 'Non-Hodgkin Lymphoma', 'Plasma Cell Myeloma', 'RAS Family Gene Mutation', 'Recurrent Diffuse Large B-Cell Lymphoma', 'Recurrent Hematologic Malignancy', 'Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma', 'Refractory Diffuse Large B-Cell Lymphoma', 'Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma', 'Therapy-Related Acute Myeloid Leukemia', 'Therapy-Related Myelodysplastic Syndrome', 'TP53 Gene Mutation']}, 'descriptionModule': {'briefSummary': "This pilot clinical trial studies the side effects of irradiated donor cells following stem cell transplant in controlling cancer in patients with hematologic malignancies. Transfusion of irradiated donor cells (immune cells) from relatives may cause the patient's cancer to decrease in size and may help control cancer in patients receiving a stem cell transplant.", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the toxicity associated with the administration of irradiated haploidentical cells (IHC) to patients with high-risk hematologic malignancies.\n\nSECONDARY OBJECTIVES:\n\nI. To determine if there is evidence of disease response associated with IHC.\n\nTERTIARY OBJECTIVES:\n\nI. To determine if treatment with the irradiated cells induces an immune response targeting tumor associated epitopes.\n\nOUTLINE: Patients are assigned to 1 of 2 cohorts.\n\nCOHORT I: Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous hematopoietic stem cell transplantation (HSCT), patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.\n\nCOHORT II: Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.\n\nAfter completion of study treatment, patients will be followed up within 8 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with disease (stage) eligible per cohort\n* COHORT 1: patients undergoing high dose chemotherapy with autologous stem cell rescue and ?high-risk? disease as defined below:\n\n * Diffuse large cell lymphoma or peripheral T cell lymphoma (including specified World Health Organization \\[WHO\\] subtypes) not in computed tomography (CT)-positron emission tomography (PET) complete remission at time of high dose therapy\n * Diffuse large cell lymphoma with ?double hit? or ?double expressor? features\n * Diffuse large cell lymphoma or peripheral T cell lymphoma (including WHO specified subtypes) refractory to standard induction therapy OR relapsing within 1 year of treatment OR in greater that second complete remission (CR)\n * Mantle cell lymphoma not in CR1\n * Multiple myeloma with ONE (or more) of the following high risk features:\n\n * Less than very good partial remission at time of high dose therapy\n * High Revised-International Staging System (R-ISS) (stage III ? 2 microglobulin \\>= 5.5 plus lactate dehydrogenase \\[LDH\\] \\> upper limit of normal \\[ULN\\] and/or del17p, t(4;14), t(14;16)) at time of diagnosis\n * Cytogenetics or fluorescent in situ hybridization (FISH) del17p\n* COHORT 2: patients with high risk disease having undergone an allogeneic hematopoietic stem cell transplant from a 10/10 human leukocyte antigen (HLA) matched donor with one of the following disease subtypes:\n\n * Acute myeloid leukemia (AML) in CR1 with high risk features (European Leukemia Network \\[ELN\\]) at presentation\n\n * Diagnostic sample with either t(6;9), t(9;22), 11q23, inv 3, -5, -7, del17p, complex cytogenetics, NPMwt-flt3ITD+, OR p53 mutation (mut); patients whose samples have mutations in RUNX1 or ASXL1 are also eligible (unless the patient has favorable cytogenetics)\n * AML in CR1 with measurable minimal residual disease (MRD) by molecular (e.g., myeloid mutation profile, polymerase chain reaction \\[PCR\\] for NPM1, core-binding factor \\[CBF\\], mixed lineage leukemia \\[MLL\\]) or flow cytometry\n * AML not in CR1 (including patients with morphologic CR but with incomplete recovery, CRi)\n * Myelodysplastic syndrome (MDS) with complex cytogenetics, 17p deletion or p53 mutation, or JAK2 or RAS mutation\n * Treatment-related MDS or AML\n * Acute lymphoblastic leukemia (ALL) not in CR1\n * ALL with MRD\n * Any hematologic malignancy relapsed or with persistent disease after allogeneic hematopoietic stem cell transplant\n * Multiple myeloma\n * Non-Hodgkin lymphoma (NHL) with chemoresistant disease at time of transplant\n * Any patient undergoing allogeneic hematopoietic stem cell transplant and an anticipated rate of relapse \\> 80% based upon published data and for which there is consensus amongst the Hematologic Malignancies Tumor Study Group that enrollment is appropriate\n* Availability of a genetic child, genetic parent or sibling as a potential HLA haploidentical donor\n* Meets standard eligibility requirements for high dose chemotherapy with autologous stem cell rescue (COHORT 1) or allogeneic hematopoietic stem cell transplant (COHORT 2) and has signed consent for those procedures\n* DONOR: Donor must be related to patient and be partially (\\>= 3/6 antigen) HLA-matched\n* DONOR: Donor must meet all Robert Wood Johnson (RWJ) Blood Services requirements for hematopoietic stem cell donation including:\n\n * Age \\>= 18 years old;\n * Normal hemogram (white blood cells \\[WBC\\] 4.0-10.0 x 10\\^3/mm\\^3; platelet count 150,000 to 440,000/mm\\^3 ; hemoglobin/hematocrit; 12.5-18 g/dl, 38 to 54%\n * Not pregnant or lactating;\n * Not human immunodeficiency virus (HIV)-1, HIV-2, hepatitis C virus (HCV), hepatitis B core or human T-cell lymphotropic virus (HTLV)-I/II seropositive; hepatitis B surface antigen (HB S ag) (-); meet other infectious disease screening criteria utilized by RWJ Blood Services;\n * No uncontrolled infections, other medical or psychological/social conditions, or medications that might increase the likelihood of patient or donor adverse effects or poor outcomes;\n * Meet other blood bank criteria for blood product donation (as determined by RWJ Blood Center screening history and laboratory studies)\n\nExclusion Criteria:\n\n* Non-English speaking person\n* Patients undergoing haploidentical allogeneic hematopoietic stem cell transplants are not eligible; patients undergoing \\< 10/10 HLA allele matched allogeneic transplant are not eligible\n* Pregnant women\n* DONOR: Non-English speaking person\n* DONOR: Pregnant women'}, 'identificationModule': {'nctId': 'NCT03272633', 'briefTitle': 'Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Post-Transplant Use of Irradiated Haplo-Allogeneic Cells', 'orgStudyIdInfo': {'id': '011702'}, 'secondaryIdInfos': [{'id': 'NCI-2017-01537', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'Pro20170000537'}, {'id': '011702', 'type': 'OTHER', 'domain': 'Rutgers Cancer Institute of New Jersey'}, {'id': 'P30CA072720', 'link': 'https://reporter.nih.gov/quickSearch/P30CA072720', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort I (initial IHC within 42 days)', 'description': 'Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.', 'interventionNames': ['Procedure: Allogeneic Hematopoietic Stem Cell Transplantation', 'Biological: Irradiated Allogeneic Cells']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort II (initial IHC within 70 days or after relapse)', 'description': 'Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.', 'interventionNames': ['Procedure: Allogeneic Hematopoietic Stem Cell Transplantation', 'Biological: Irradiated Allogeneic Cells']}], 'interventions': [{'name': 'Allogeneic Hematopoietic Stem Cell Transplantation', 'type': 'PROCEDURE', 'otherNames': ['Allogeneic Hematopoietic Cell Transplantation', 'allogeneic stem cell transplantation', 'HSC', 'HSCT'], 'description': 'Receive IHC', 'armGroupLabels': ['Cohort I (initial IHC within 42 days)', 'Cohort II (initial IHC within 70 days or after relapse)']}, {'name': 'Irradiated Allogeneic Cells', 'type': 'BIOLOGICAL', 'description': 'Correlative studies', 'armGroupLabels': ['Cohort I (initial IHC within 42 days)', 'Cohort II (initial IHC within 70 days or after relapse)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}], 'overallOfficials': [{'name': 'Roger Strair', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers Cancer Institute of New Jersey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine, RWJMS', 'investigatorFullName': 'Roger Strair, MD, PhD', 'investigatorAffiliation': 'Rutgers Cancer Institute of New Jersey'}}}}