Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma
Plain-language summary
This Phase 2 trial is comparing ATL-RIC, mRIC, and other medications against other options for people whose T-cell lymphoma has come back or has not responded to previous treatment. Patients are randomly assigned to different treatment groups to see which approach works best. It is available at 2 US locations.
Who can join (key eligibility)
- Age 12 Years to 120 Years years
- Lymphoma came back or did not respond to prior treatment
- Must be well enough for treatment (adequate performance status)
- May require specific number of prior treatments
Final eligibility is determined by the trial team. This list is a starting point only.
What's being tested
ATL-RIC (DRUG): e-ATG 40 mg/kg/day IV on days -14 and -13, pentostatin 4 mg/m2/day IV on days -11 and -7, low-dose cyclophosphamide (5 mg/kg) orally daily on days -11 through -4; busulfan IV, pharmacokinetically dosed, on days -3 and -2, filgrastim or biosimilar drug 5mcg /kg/day subcutaneous on days -12, -8, and -4, ruxolitinib 45 mg/day from day -12 through day -2, and zidovudine 300mg orally three times a day from day -1 through day +50. | mRIC (DRUG): e-ATG 40 mg/kg/day IV on days -14 and -13, pentostatin 4 mg/m2/day IV on days -11 and -7, lowdose cyclophosphamide (5 mg/kg) orally daily on days -11 through -4; busulfan IV, pharmacokinetically dosed, on days -3 and -2, filgrastim or biosimilar drug 5 mcg/kg/day subcutaneous on days -12, -8, and -4. | allo HCT (PROCEDURE): Stem cell transplant | RIC (DRUG): e-ATG 40 mg/kg/day IV on days -14 and -13. Pentostatin 4mg /m2/day IV on days -11 and -7. Cyclophosphamide 5 mg/kg orally daily on days -11 through -4. Busulfan IV, pharmacokinetically dosed, on days -3 and -2. | GVHD prophylaxis (DRUG): High-dose, post-transplantation cyclophosphamide (PTCy) on days +3 and +4 ( 25 mg/kg/day on both arms), sirolimus on days +5 through +60, and mycophenolate mofetil (MMF) on days +5 through +25. | IOC (DRUG): e-ATG40 mg/kg/day IV on days -14 and -13. Pentostatin 4 mg/m2/day IV on days -9 and -5. Cyclophosphamide 5 mg/kg orally daily on days -9 through -2
- Drugs / treatments
- ATL-RIC, mRIC, allo HCT, RIC, GVHD prophylaxis, IOC
- Treatment length
- Ask the trial team for details
- Visit frequency
- Ask the trial team for details