Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy
Running, not enrolling · Phase 2
Conditions studied: Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Biphenotypic/Undifferentiated Leukemia, Chronic Myelogenous Leukemia, Myelodysplasia, Relapsed Large Cell Lymphoma, Mantle Cell Lymphoma, Hodgkin Lymphoma, Burkitt Lymphoma, Relapsed T-Cell Lymphoma, Lymphoplasmacytic Lymphoma
In brief
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.
Key facts
- Study ID
- NCT03674411
- Run by
- Masonic Cancer Center, University of Minnesota
- People needed
- 22
- Starts
- 2019-01-02
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-01-06
Who can join
Age: any, up to 55. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Patients with a HLA matched sibling donor or a HLA matched unrelated donor who is available for marrow or peripheral blood stem cell collection at the desired time of transplant.
- Pregnant or breast feeding. The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. Females of childbearing potential must have a blood test or urine study within 14 days prior to study enrollment to rule out pregnancy.
- Evidence of human immunodeficiency virus (HIV) infection or known HIV positive serology.
- Active bacterial, viral or fungal infection (currently taking medication and persistence of clinical signs and symptoms) with a minimum of 4 weeks of anti-fungal treatment
- Prior autologous or allogeneic transplant.
- Other active malignancy.
- Subjects >2 3 years of age unable to receive TBI 1320 cGy due to extensive prior therapy including >12 months alkylator therapy or >6 months alkylator therapy with extensive radiation, or prior Y-90 ibritumomab (Zevalin) or I-131 tostumomab (Bexxar), as part of their salvage therapy.
Where it is running
- Masonic Cancer Center at University of Minnesota — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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