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

Phase 2

Active, not recruiting

• Conditions: Acute Lymphocytic Leukemia; Relapsed Large Cell Lymphoma; Mantle Cell Lymphoma; Acute Myeloid Leukemia; Myelodysplasia; Burkitt Lymphoma; Hodgkin Lymphoma; Relapsed T-Cell Lymphoma; Biphenotypic/Undifferentiated Leukemia; Lymphoplasmacytic Lymphoma
• Interventions: Drug: Fludarabine (FLU); Drug: Cyclophosphamide (CY); Drug: Total Body Irradiation (TBI); Drug: Tacrolimus (Tac); Drug: Mycophenolate Mofetil (MMF); Drug: Granulocyte Colony-Stimulating Factor (G-CSF); Drug: Busulfan (BU); Drug: Melphalan; Drug: MGTA 456 Infusion

• Registration Number: NCT03674411
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-14
• Study First Submitted QC: 2018-09-14
• Study First Posted: 2018-09-17
• Study Start: 2019-01-02
• Primary Completion: 2020-06-23
• Results First Submitted: 2023-12-27
• Results First Submitted QC: 2024-01-26
• Results First Posted: 2024-01-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-04-10
• Study Completion: 2024-06-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FLU, CY, TBI + MGTA-456 infusion	Fludarabine (FLU)	-
FLU, CY, TBI + MGTA-456 infusion	Granulocyte Colony-Stimulating Factor (G-CSF)	-
FLU, CY, TBI + MGTA-456 infusion	Melphalan	-
FLU, CY, TBI + MGTA-456 infusion	Total Body Irradiation (TBI)	-
FLU, CY, TBI + MGTA-456 infusion	Mycophenolate Mofetil (MMF)	-
FLU, CY, TBI + MGTA-456 infusion	Cyclophosphamide (CY)	-
FLU, CY, TBI + MGTA-456 infusion	MGTA 456 Infusion	-
FLU, CY, TBI + MGTA-456 infusion	Tacrolimus (Tac)	-
FLU, CY, TBI + MGTA-456 infusion	Busulfan (BU)	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Neutrophil Recover	Day 14	Percentage of participants with neutrophil recovery by day 14 after transplantation in recipients of MGTA-456.

Secondary Outcome Measures

Name	Time	Method
Grades III-IV Acute GVHD	Day 100	Incidence of grades III-IV acute GVHD at day 100
Overall Survival (OS)	2 Years	Incidence of overall survival (OS) at 2 years
Chronic GVHD	1 Year	Incidence of chronic GVHD at 1 year
Treatment Related Mortality (TRM)	6 Months	Incidence of TRM at 6 months
Grades II-IV Acute GVHD	Day 100	Incidence of grades II-IV acute GVHD at day 100
Non-catheter Associated Bacterial Infections	Day 100	Incidence of non-catheter associated bacterial infections by day 100
Hospitalization Rates	Day 0 and Day 100	Number of days alive without hospitalization between days 0 and 100 after transplantation
Secondary Graft Failure	2 Years	Incidence of secondary graft failure
Platelet Recovery	Day 42	Incidence of platelet recovery at day 42
Relapse	2 Years	Incidence of relapse at 2 years
Event-Free Survival (EFS)	2 Years	Incidence of event-free survival (EFS) at 2 years

Trial Locations

Locations (1)

Masonic Cancer Center at University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States