Post-Transplant Cyclophosphamide in Patients Aged >/=70 Years Undergoing Haploidentical Transplant

• Status: Not yet recruiting
• Trial end date: 2028-07-01
• Target enrollment: 0
• Participant gender: All

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 >/= 70 years with hematologic malignancies.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ronald Paquette
• Treatments: Cyclophosphamide

Criteria

Inclusion Criteria:

• Patient age >/= 70 years

• Patient has a related donor who is a human leukocyte antigens (HLA) haploidentical match

• Patient and Donor sign the Informed Consent Form for the study

• 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 (PBSC)

Exclusion Criteria:

• 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

• Inability to collect at least 3 x 10^6 CD34+ PBSCs/kg recipient weight from the donor

• 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.