NCT05849207

Post-Transplant Cyclophosphamide in Patients Aged >/= 65 Years Undergoing Haploidentical Transplant

IIT2022-03-Paquette-GeriBMT: A Phase I Study of De-Escalation of Post-Transplant Cyclophosphamide Dosing in Patients Aged >/= 65 Years Undergoing Conditioning With Fludarabine and Total Body Irradiation 800 cGy

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Ronald Paquette · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this phase 1 study is to determine the optimal dose of the immune suppressive drug, cyclophosphamide, following standard allogeneic stem cell transplant in patients aged \>/= 65 years with hematologic malignancies.

Detailed description

The patients will receive a standard dose, or a reduced amount of the immune suppressive drug, cyclophosphamide, that is routinely administered after the transplant procedure. The following procedures will be performed: cardiac MRI scans and/or transthoracic echocardiogram (TTE); laboratory tests, geriatric assessments and tests to measure strength and stability. Participation in the study is expected to last up to one year with follow-up visits occurring on Day +30, Day +100, Day +180 and Day +365 following allogenic stem cell transplant.

Conditions

• Hematologic Malignancies

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Cyclophosphamide will be administered at 50, 40, 32, or 25 mg/k/d intravenous infusion (IV) continuously for two days starting 60-72 hours after transplant.

Timeline

• Start date: 2023-10-24
• Primary completion: 2027-07-01
• Completion: 2028-07-01
• First posted: 2023-05-08
• Last updated: 2025-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study