Allo HSCT Using RIC and PTCy for Hematological Diseases
Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases
Masonic Cancer Center, University of Minnesota
56 participants
May 1, 2023
INTERVENTIONAL
Conditions
Summary
This is a Phase II study following subjects proceeding with our Institutional non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion using post-transplant cyclophosphamide (PTCy), sirolimus and MMF GVHD prophylaxis.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
On day 0, a target dose of 5 x 106 CD34 cells/kg will be infused.
300 mg/day from day -7 to day 0. Allopurinol 150mg/m2/day for pediatric participants.
30 mg/m2 IV over 1 hour. Administered on day -6 to day -2.
Administered as a 2 hour IV infusion on day -6, +3, and +4.
On day 0, a target dose of 3 x 108 nucleated cells/kg recipient weight will be infused.
The dose of TBI will be 200 cGy given in a single fraction on day -1.
All participants begin +5 to day +60. Loading dose on day +5 of 5 mg/m2/day orally once (max dose of 8 mg). Maintenance dose 2.5 mg/m2 orally daily to maintain a level of 8-12 ng/ml (max dose of 4 mg).
All patients begin day +5 through day +35. 3 gram/day IV/PO for patients who are ≥ 40 kg divided in 2 doses. In obese patients (\>125% IBW) 15 mg/kg every 12 hours may be considered. Pediatric patients will receive MMF at the dose of 15 mg/kg/dose (maximum of 1 gram per dose) every 8 hours.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05805605