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 range

55 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants With Neutrophil Recover

Timeframe: Day 14

Trial details

NCT IDNCT03674411

SponsorMasonic Cancer Center, University of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-23

Results submitted2023-12-27

View on ClinicalTrials.gov More Acute Myeloid Leukemia trials