Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-30 @ 5:28 AM
Study NCT ID:
NCT03365661
Status:
WITHDRAWN
Last Update Posted:
2018-11-09
First Post:
2017-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
QUILT-3.034: Non-Myeloablative TCRa/b Deplete Haplo HSCT With Post ALT-803 for AML
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582303', 'term': 'ALT-803'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sponsor halted study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-10-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-07', 'studyFirstSubmitDate': '2017-12-03', 'studyFirstSubmitQcDate': '2017-12-03', 'lastUpdatePostDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of disease response', 'timeFrame': 'Day 28', 'description': 'Rate of donor neutrophil engraftment in the absence of disease at Day +28. Neutrophil engraftment is defined as absolute neutrophil count (ANC) ≥ 5 X 10 8 /L.'}], 'secondaryOutcomes': [{'measure': 'Disease Free Survival (DFS)', 'timeFrame': '12 months', 'description': 'Incidence of disease free survival (DFS).'}, {'measure': 'Treatment Related Mortality (TRM)', 'timeFrame': '12 months', 'description': 'Incidence of treatment related mortality (TRM).'}, {'measure': 'Disease Relapse', 'timeFrame': '12 months', 'description': 'Incidence of disease relapse.'}, {'measure': 'Grade II-IV acute Graft versus Host Disease (aGVHD)', 'timeFrame': 'Day 100', 'description': 'Incidence of acute Graft versus Host Disease measured by the number of T-cells infused or NK cells engrafted causing GVHD syndrome.'}, {'measure': 'Serious Adverse Events from ALT-803 (Early Schedule)', 'timeFrame': '1 Year', 'description': 'Incidence of serious adverse events from ALT-803 will be measured for an initial 2 doses, given one week apart.'}, {'measure': 'Serious Adverse Events from ALT-803 (Late Schedule)', 'timeFrame': '1 Year', 'description': 'Incidence of serious adverse events from ALT-803 will be measured for 16 doses, given over 4 weeks.'}, {'measure': 'Chronic Graft versus Host Disease (cGVHD)', 'timeFrame': '1 year', 'description': 'Incidence of chronic Graft versus Host Disease will be measured by the number of T-cells infused or NK cells engrafted causing GVHD syndrome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AML', 'MDS'], 'conditions': ['High-Risk Acute Myeloid Leukemia', 'Treatment-Related Acute Myeloid Leukemia', 'Secondary Acute Myeloid Leukemia', 'Myelodysplastic Syndrome']}, 'descriptionModule': {'briefSummary': 'This is a phase II multi-institutional therapeutic study of a non-myeloablative T cell receptor (TCR) alpha/beta depleted haploidentical transplantation with post-transplant immune reconstitution using ALT-803 for the treatment of high-risk myeloid leukemia (AML), treatment-related/secondary AML, and myelodysplastic syndrome (MDS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 to ≤70 years\n* Meets one of the following disease and risk categories:\n\n * High-Risk Acute Myeloid Leukemia (AML) with predicted risk of relapse higher than 30%, which includes, but not limited to the following:\n\n * Patients in morphological remission (CR1 or beyond) with minimal residual disease as quantified either by flow cytometry, or by cytogenetics or molecular markers.\n * Patients with the following karyotypes in morphological CR or CRi: ELN-Intermediate I, Adverse, ELN-Intermediate-II. (18) (Examples include monosomal karyotype, complex karyotype, mutant p53, mutant RUNX1, mutant ASXL1, mutant FLT3-ITD, mutant DNMT3A, Inversion 3, T(6:9), KIT mutated core binding factor AML)\n * Treatment-Related AML and Secondary AML in morphological remission (CR1 or beyond) with minimal residual disease as quantified either by flow cytometry, or by cytogenetics or molecular markers\n * Myelodysplastic Syndrome (MDS) with \\< 5% blasts by morphology and meets at least one of the following:\n\n * Received intensive induction chemotherapy (i.e. 7+3 or MEC) OR\n * Progression after 4 cycles of hypomethylating agents\n * The donor and recipient must be HLA identical for at least one haplotype (using high resolution DNA based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1\n* Karnofsky performance status ≥ 60% (appendix IV)\n* Adequate organ function within 14 days of study registration (30 days for pulmonary and cardiac) defined as:\n\n * Hepatic: AST and ALT \\< 3 x upper limit of institutional normal\n * Renal: estimated glomerular filtration rate (GFR) ≥ 40 mL/min/1.73m2\n * Pulmonary: oxygen saturation ≥ 90% on room air with no symptomatic pulmonary disease. If symptomatic or prior known impairment DLCOcor ≥ 40%.\n * Cardiac: LVEF ≥ 40% by echocardiography, MUGA, or cardiac MRI, no uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities\n* Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to transplant (excluding preparative regimen pre-medications)\n* Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy\n* Voluntary written consent prior to the performance of any research related procedures\n\nExclusion Criteria:\n\n* Acute leukemias of ambiguous lineage\n* Allogeneic transplant for AML within the previous 6 months (no time limit for autologous transplant)\n* Active CNS disease - if a history of AML related CNS involvement, screening CSF analysis must be negative\n* Pregnant or breastfeeding - The agents used in this study include those that fall under Pregnancy Category D - have known teratogenic potential. Women of child bearing potential must have a negative pregnancy test at screening\n* Active autoimmune disease requiring systemic immunosuppressive therapy\n* History of severe asthma and currently on systemic chronic medications (mild asthma requiring inhaled steroids only is eligible)\n* New or progressive pulmonary infiltrates on screening chest x-ray or chest CT scan unless cleared for study by Pulmonary. Infiltrates attributed to infection must be stable/improving (with associated clinical improvement) after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections).\n* Uncontrolled bacterial, fungal or viral infections including HIV-1/2 or active hepatitis C/B - chronic asymptomatic viral hepatitis is allowed\n* Active concomitant second malignancy (i.e. has required treatment in the previous 6 months)\n* Known hypersensitivity to any of the study agents\n* Received any investigational drugs within the 14 days before 1st dose of fludarabine'}, 'identificationModule': {'nctId': 'NCT03365661', 'briefTitle': 'QUILT-3.034: Non-Myeloablative TCRa/b Deplete Haplo HSCT With Post ALT-803 for AML', 'organization': {'class': 'OTHER', 'fullName': 'Masonic Cancer Center, University of Minnesota'}, 'officialTitle': 'QUILT-3.034: Multi-Center Trial of Non-Myeloablative TCRa/b Deplete Haploidentical Hematopoietic Cell Transplantation With Post HCT ALT-803 in High-Risk Myeloid Diseases', 'orgStudyIdInfo': {'id': '2016LS057'}, 'secondaryIdInfos': [{'id': 'MT2016-06', 'type': 'OTHER', 'domain': 'Masonic Cancer Center, University of Minnesota'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ALT-803', 'interventionNames': ['Biological: ALT-803']}], 'interventions': [{'name': 'ALT-803', 'type': 'BIOLOGICAL', 'description': 'A reduced intensity conditioning starts on Day -6, (CY/FLU/TBI/TLI) followed by infusion of a TCRα/β-deplete haploidentical graft on Day 0. Two doses of ALT-803 are given initially (early) 1 week apart to facilitate NK cell expansion. ALT-803 maintenance (late) for immune reconstitution begins at Day 42 and consists of 4 weekly doses, followed by 4 weeks off. Up to four 8 week treatment courses are permitted. No post-transplant GVHD prophylaxis is administered unless the final donor cell product contains \\> 2 x 105 α/β T cells/kg recipient weight.', 'armGroupLabels': ['ALT-803']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Masonic Cancer Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Sarah Cooley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masonic Cancer Center, University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Minnesota', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}