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

Ronald Paquette

Status and phase

Enrolling

Phase 1

Conditions

Hematologic Malignancies

Treatments

Drug: Cyclophosphamide

Study type

Interventional

Funder types

Other

Identifiers

NCT05849207

IIT2022-03-PAQUETTE-GERIBMT

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 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
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.