RecruitingPhase 2NCT05805605

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


Sponsor

Masonic Cancer Center, University of Minnesota

Enrollment

56 participants

Start Date

May 1, 2023

Study Type

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

Max Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a reduced-intensity stem cell transplant (using a gentler conditioning regimen and a post-transplant drug called cyclophosphamide to prevent graft-versus-host disease) for patients with blood cancers or other blood disorders who need a donor stem cell transplant. **You may be eligible if:** - You are between 0 and 75 years old and in reasonably good physical condition - A matching or half-matched donor is available (related sibling, matched unrelated donor, or a haploidentical relative) - You have a blood cancer or disorder, such as: - Acute myeloid leukemia (AML) in second remission, or certain high-risk first remissions - Acute lymphoblastic leukemia (ALL) in second remission or high-risk first remission - Other blood cancers or disorders as determined by your medical team - Your cancer is in remission with minimal or no detectable disease at the time of transplant **You may NOT be eligible if:** - You have active, uncontrolled cancer (not in remission) - Your general health or organ function is too poor for transplant - No suitable donor is available Talk to your doctor to see if this trial is right for you.

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

BIOLOGICALPeripheral Blood Stem Cell Transplant

On day 0, a target dose of 5 x 106 CD34 cells/kg will be infused.

DRUGAllopurinol 300 MG

300 mg/day from day -7 to day 0. Allopurinol 150mg/m2/day for pediatric participants.

DRUGFludarabine

30 mg/m2 IV over 1 hour. Administered on day -6 to day -2.

DRUGCyclophosphamide

Administered as a 2 hour IV infusion on day -6, +3, and +4.

BIOLOGICALBone Marrow Cell Transplant

On day 0, a target dose of 3 x 108 nucleated cells/kg recipient weight will be infused.

RADIATIONTotal Body Irradiation

The dose of TBI will be 200 cGy given in a single fraction on day -1.

DRUGSirolimus 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).

DRUGMycophenolate 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.


Locations(1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, United States

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NCT05805605


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