NCT05805605

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myelogenous Leukemia
• Acute Lymphocytic Leukemia
• Biphenotypic Acute Leukemia
• Undifferentiated Leukemia
• Prolymphocytic Leukemia
• Chronic Myelogenous Leukemia
• Plasma Cell Leukemia
• Myelodysplastic Syndromes
• Leukemia, Myeloid
• Myelodysplastic Syndrome With Excess Blasts-1
• Burkitt Lymphoma
• Relapsed T-Cell Lymphoma
• Relapsed Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma
• Marginal Zone Lymphoma
• Follicular Lymphoma
• Myeloproliferative Neoplasm
• Myelofibrosis

Interventions

Type	Name	Description
BIOLOGICAL	Peripheral Blood Stem Cell Transplant	On day 0, a target dose of 5 x 106 CD34 cells/kg will be infused.
DRUG	Allopurinol 300 MG	300 mg/day from day -7 to day 0. Allopurinol 150mg/m2/day for pediatric participants.
DRUG	Fludarabine	30 mg/m2 IV over 1 hour. Administered on day -6 to day -2.
DRUG	Cyclophosphamide	Administered as a 2 hour IV infusion on day -6, +3, and +4.
BIOLOGICAL	Bone Marrow Cell Transplant	On day 0, a target dose of 3 x 108 nucleated cells/kg recipient weight will be infused.
RADIATION	Total Body Irradiation	The dose of TBI will be 200 cGy given in a single fraction on day -1.
DRUG	Sirolimus Pill	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).
DRUG	Mycophenolate Mofetil	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.

Timeline

• Start date: 2023-05-01
• Primary completion: 2027-10-22
• Completion: 2028-10-22
• First posted: 2023-04-10
• Last updated: 2025-07-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study