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Stem Cell Transplantation

MGTA-456 for High-Risk Cancer

Phase 2
Waitlist Available
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must weigh >11 kg
Subjects must be ≤55 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing whether expanding stem cells from umbilical cord blood in culture with cytokines can improve lympho-hematopoietic recovery after a myeloablative conditioning.

Who is the study for?
This trial is for patients under 55 years old, weighing over 11 kg, with high-risk malignancies like various leukemias and lymphomas. They must have a partially matched umbilical cord blood unit for transplant and meet specific health criteria including good organ function and performance status. Pregnant women, those with HIV or other active cancers/infections, or previous transplants are excluded.Check my eligibility
What is being tested?
The trial tests the effectiveness of expanded umbilical cord blood stem cells combined with a uniform myeloablative conditioning regimen (using drugs like Melphalan) and post-transplant immunoprophylaxis to improve recovery in patients with high-risk malignancies.See study design
What are the potential side effects?
Potential side effects include reactions to the infusion such as fever or chills, risk of infections due to immune suppression from conditioning treatments, organ toxicity from chemotherapy drugs used in conditioning regimens (like liver or kidney issues), and graft-versus-host disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh more than 11 kilograms.
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I am 55 years old or younger.
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I have a partially matched cord blood unit for my transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Neutrophil Recover
Secondary outcome measures
Chronic GVHD
Event-Free Survival (EFS)
Grades II-IV Acute GVHD
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: FLU, CY, TBI + MGTA-456 infusionExperimental Treatment9 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melphalan
FDA approved
Total Body Irradiation (TBI)
2016
Completed Phase 3
~1220
Tacrolimus
FDA approved
Mycophenolate mofetil
FDA approved
Filgrastim
FDA approved
Busulfan
FDA approved
Cyclophosphamide
FDA approved

Find a Location

Who is running the clinical trial?

Masonic Cancer Center, University of MinnesotaLead Sponsor
271 Previous Clinical Trials
14,603 Total Patients Enrolled

Media Library

MGTA-456 Infusion (Stem Cell Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT03674411 — Phase 2
Acute Lymphoblastic Leukemia Research Study Groups: FLU, CY, TBI + MGTA-456 infusion
Acute Lymphoblastic Leukemia Clinical Trial 2023: MGTA-456 Infusion Highlights & Side Effects. Trial Name: NCT03674411 — Phase 2
MGTA-456 Infusion (Stem Cell Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03674411 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what medical cases is Total Body Irradiation (TBI) commonly prescribed?

"Total Body Irradiation (TBI) is frequently used to manage dermatitis, atopic and can be employed to confront other maladies such as multiple sclerosis, leukemia, myelocytic acute, and psoriasis."

Answered by AI

What risks accompany Total Body Irradiation (TBI) treatments?

"Our team at Power has assessed the safety of Total Body Irradiation (TBI) to be a 2, as no clinical data is available that confirms efficacy but some evidence exists supporting its security."

Answered by AI

Are there any additional clinical experiments which have explored the effects of Total Body Irradiation (TBI)?

"Presently, 1132 research protocols pertaining to Total Body Irradiation (TBI) are active. Of those, 208 have achieved Phase 3 status while the majority of these trials originate from Leipzig, Sachsen. Additionally, 32102 different sites around the world are conducting studies related to this therapy."

Answered by AI

How many individuals have enrolled in this research endeavor?

"This research trial is no longer taking participants. Initially posted on the 2nd of January 2019 and last edited on November 2nd 2022, it has since been closed off for recruitment. There are presently 3009 trials actively accepting patients with myelodysplasia and 1132 studies recruiting those affected by Total Body Irradiation (TBI)."

Answered by AI

Are there still vacancies available in this research project?

"Unfortunately, clinicaltrials.gov indicates that no more candidates are being accepted for this study which was initially posted on the 2nd of January 2019 and last updated nearly three years later. However, there is an abundance of other medical trials currently accepting patients; a total of 4141 exist at present."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy
2019. "Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03674411.
All > Waldenstrom Macroglobulinemia > Mantle Cell Lymphoma
~4 spots leftby Apr 2025
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