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
Ronald Paquette
26 participants
Oct 24, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- Patient age >/= 65 years
- Patient and related Donor (if applicable) sign the Informed Consent Form for the study. If donor is unrelated, donor does not sign Informed Consent Form and this will not affect recipient study eligibility.
- Patient meets standard criteria for allogeneic stem cell transplant
- Patient is deemed suitable to receive Flu/TBI 800 conditioning regimen as standard of care transplant
- Donor is willing to donate peripheral blood stem cells
Exclusion Criteria8
- Patient has a diagnosis of myelofibrosis
- Patient has high titer antibodies (>10,000 mean fluorescent intensity) against one or more donor HLA antigens
- Patient has undergone prior autologous or allogeneic stem cell transplant
- Requiring sedation for cardiac MRIs.
- Prohibited Implants and/or Devices:
- Mechanical, magnetic or electrical activated implants (i.e. cardiac pacemakers, neurostimulators and infusion pumps)
- Ferromagnetic implants and ferromagnetic foreign bodies, such as intracranial, aneurysm clips, shrapnel and intraocular metal chips as these could become dislodged.
- Subjects with claustrophobia, problems being in enclosed spaces, or inability to lie supine.
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05849207