At a glance
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Three-arm Clinical Trial for Patients With Hematologic Malignancies and Mismatched Donors - Haploidentical, 1 Antigen Mismatch Related or Unrelated, and Matched Unrelated Donor (MUD)- Using a T-cell Replete Allograft and High-dose Post-transplant Cyclophosphamide
In Brief
A Phase 2 clinical trial evaluating Cyclophosphamide, Fludarabine, and 8 other interventions for Blood Stem Cell Transplant Failure and 2 related conditions. Completed, enrolled 176 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to learn about the safety of giving a stem cell transplant from a tissue-mismatched donor, followed by cyclophosphamide, to patients with certain types of blood disorders or blood cancers. Melphalan, thiotepa, and fludarabine will also be given before the transplant. Researchers will study the health status of these patients at 3 months after the transplant.
Study Details
Timeline
Interventions
50 mg/kg/day intravenous (IV) over 3 hours on Days 3 and 4.
40 mg/m\^2 IV over 1 hour on Days -6, -5, -4, and -3.
140 mg/m\^2 IV (or 100 mg/m\^2 with reduced intensity Regimen 2) over 30 minutes on Day -8.
10 mg/kg IV every 4 hours for a total of 10 doses starting just prior to first dose of Cyclophosphamide on Days 3 and 4.
CD20+ lymphoid malignancies: 375 mg/m2 on Day -13 followed by 1000 mg/m2 on Day -6, +1, and +8.
Infusion of donor's stem cells by vein on Day 0, may last anywhere from 15 minutes to several hours.
5 mg/kg Regimen 1 (or 5 mg/kg with reduced intensity Regimen 2) IV over 4 hours on Day -7.
0.015 mg/kg by vein or orally daily starting on Day +5 for 3 months
15 mg/kg/dose orally three times a day starting on Day +5 to Day +100 or otherwise indicated
5 mcg/kg/day subcutaneously starting Day 7 once a day daily until neutrophil recovery \> 1000/mcl.