At a glance
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Single-Arm, Open Label, Interventional Phase II Clinical Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy
In Brief
A Phase 2 clinical trial evaluating Fludarabine (FLU), Cyclophosphamide (CY), and 7 other interventions for Acute Myeloid Leukemia and 10 related conditions. Active but no longer recruiting, targeting 22 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
25 mg/m2 IV over 1 hour (\<10 kg: 0.83 mg/kg IV over 1 hour)
60 mg/kg IV over 2 hours
165 cGy twice daily
Tacrolimus will start day -3 and will be administered as a continuous IV infusion at a starting dose of 0.03 mg/kg/day. Goal trough levels will be 10-15 ng/mL for the first 14 days post-transplant and then decreased to a goal of 5-10 ng/ml thereafter.
MMF 3 gram/day IV/PO for adult patients divided in 2 or 3 doses. Pediatric patients will receive MMF at the dose of 15 mg/kg/dose (max 1 gram per dose) every 8 hours beginning day -3.
5 ug/kg/d until the absolute neutrophil count (ANC) is \>2500/uL for 2 consecutive days
BU IV once daily with dose based on Pharmacokinetics (PK) calculator over 3 hours
50 mg/m2/day (1.7 mg/kg/day if \< 10 kg) IV over 30 min
The target cell dose is \>10 x 106 CD34/kg with a maximum TNC 2.7 x 108/kg for children (\<18 years) and 8.1 × 108 cells/kg \[expanded product only\] for adults based on the highest cell dose windows evaluated in prior studies.