Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy (NCT03674411) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy
United States22 participantsStarted 2019-01-02
Plain-language summary
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.
Who can participate
Age range55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pre-cryopreserved TNC dose \>1.0 x 107 per kilogram recipient weight. HLA matching is initially based on a minimum of 5 of 8 HLA alleles at high resolution A, B, C, DRB1 typing; searches will be performed according to the current Magenta Cord Blood Search Algorithm.
Eligible Diseases:
* Acute myelogenous leukemia (AML) in morphological complete remission with:
* Minimal residual disease (MRD) by flow cytometry, or
* Intermediate to high risk leukemia in first (CR1) based on institutional criteria, eg. not favorable risk AML which is defined as having one of the following:
* t(8,21) without cKIT mutation
* inv(16) or t(16;16) without cKIT mutation
* Normal karyotype with mutated NPM1 but FLT3-ITD wild type
* Normal karyotype with double mutated CEBPA
* Acute promyelocytic leukemia (APL) in first molecular remission at the end of consolidation
* Any second or subsequent CR, or
* Secondary AML with prior malignancy that has been in remission for at least 12 months.
* Acute lymphocytic leukemia (ALL) at the following stages:
* High risk first morphological, cytogenetic and molecular CR with:
* MRD by flow cytometry, or
* Diagnosis of Philadelphia chromosome (Ph)+ ALL, or
* MLL rearrangement at diagnosis with slow early response at Day 14, or
* Hyp…
What they're measuring
1
Percentage of Participants With Neutrophil Recover
Timeframe: Day 14
Trial details
NCT IDNCT03674411
SponsorMasonic Cancer Center, University of Minnesota