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Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy

StatusActive, Not Recruiting
PhasePhase 2
Started2019-01-02
View on ClinicalTrials.gov ↗

Amendment history

2025-12-15
Study Status, Study Design, Arms and Interventions, Outcome Measures, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events v19
Study arms1→2
Secondary endpoints11 entries, revised
Number of Days Alive Without Hospitalization Rates
2025-10-31
Completed→Active, Not Recruiting Study Status v18
Trial statusCompleted→Active, Not Recruiting
Completion date2023-12-01→2026-12-01
2025-10-27
Active, Not Recruiting→Completed Study Status v17
Trial statusActive, Not Recruiting→Completed
Completion dateestimated 2025-06-28→confirmed 2023-12-01
2024-08-19
Study Status v16
Completion date2024-06-28→2025-06-28
2024-03-15
Study Status, Adverse Events v15
Re-verified, no change to tracked fields
Show 14 earlier versions
2024-01-26
Study Status, Outcome Measures, Document Section, Outcome Measures (Results) v14
Results first postednot stated→2024-01-30
Primary endpoints1 entry, revised
Percentage of Participants With Neutrophil RecoveryRecover
2023-12-27
Study Status, Study Design, Arms and Interventions, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v13
Study arms2→1
2023-07-06
Study Status v12
Primary completion dateestimated 2023-03-31→confirmed 2020-06-23
Completion date2023-04-28→2024-06-28
2022-11-02
Study Status v11
Primary completion date2023-07→2023-03-31
Completion date2023-08→2023-04-28
2021-08-13
Study Status v10
Re-verified, no change to tracked fields
2020-08-12
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v9
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 40→confirmed 22
Study sitesdetails revised at 1 of 1 site
2020-05-14
Study Status v8
Re-verified, no change to tracked fields
2019-05-14
Study Status, Eligibility v7
Eligibility criteriarevised
[...] f 5 of 8 HLA alleles at high resolution A, B, C, DRB1 typing; ;searches will be performed according to the current Magenta [...]
2019-05-02
Study Status, Eligibility v6
Eligibility criteria+23 characters
[...] ent weight. HLA matching is initially based on a minimum of 45 of 68 HLA-A andalleles B (at low or intermediate resolution by molecular typing) and DRB1 (at high resolution byA, molecularB, C, DRB1 typing) ;searches will be performed according to the current Magenta Cord Blood Search Algorithm. Eligible Diseases: Acute myelogenous leukemia (AML) in mor [...]
2019-01-25
Study Status, Eligibility v5
Eligibility criteria+13 characters
[...] ilogram recipient weight. HLA matching is initially based on a minimum of 4 of 6 HLA-A and B (at low or intermediate resolution by mo [...]
2019-01-02
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2023-06→2023-07
Completion date2023-07→2023-08
Start dateestimated 2018-12→confirmed 2019-01-02
2018-11-08
Study Status v3
Primary completion date2023-04→2023-06
Completion date2023-05→2023-07
Start date2018-10→2018-12
2018-10-11
Study Status, Arms and Interventions v2
Re-verified, no change to tracked fields
2018-10-01
Study Identification, Study Status, Eligibility v1
Primary completion date2023-03→2023-04
Completion date2023-04→2023-05
Start date2018-09→2018-10
Eligibility criteria+196 characters
Age, Unit Cell Dose and HLA Match Criteria Subjects must be ≤55 years of age. Subjects must weigh >11 kg Subjects must have a partially HLA matched UCB unit with a p [...] wild type Normal karyotype with double mutated CEBPA Acute prolymphyocyticpromyelocytic leukemia (APL) in first molecular remission at the end of c [...] S) IPSS Int-2 or High risk (i.e. RAEB, RAEBt <5% blasts) or refractoryother anemiahigh risk features, including multiple cytopenias, high risk cytogenetics or lack of response to standard therapy.. Relapsed large-cell lymphoma, mantle-cell lymphoma and Hod [...] e in CR/PR that is ineligible f [...]
Study title-20 characters
MT2018-06:Trial PHASE II TRIAL EVALUATINGEvaluating MGTA-456 INin PATIENTSPatients WITHWith HIGHHigh-RISKRisk MALIGNANCYMalignancy
2018-09-14
Original filing
This is an single arm, open label, interventional phase II trial evaluating the efficacy of umbilical cord blood (UCB) hematopoietic stem and progenitor cells (HSPC) expanded in culture with stimulatory cytokines (SCF, Flt-3L, IL-6 and thromopoietin) on lympho-hematopoietic recovery. Patients will receive a uniform myeloablative conditioning and post-transplant immunoprophylaxis.
Trial Details
NCT Number NCT03674411
Lead Sponsor Masonic Cancer Center, University of Minnesota
Conditions Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Biphenotypic/Undifferentiated Leukemia, Chronic Myelogenous Leukemia, Myelodysplasia, Relapsed Large Cell Lymphoma, Mantle Cell Lymphoma, Hodgkin Lymphoma +3 more
Enrollment 22 participants
Start Date 2019-01-02
Primary Completion 2020-06-23 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-06