Post-Transplant Cyclophosphamide in Patients Aged >/= 65 Years Undergoing Haploidentical Transplant
Purpose
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.
Condition
- Hematologic Malignancies
Eligibility
- Eligible Ages
- Over 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- Open-label trial De-escalation of post-transplant cyclophosphamide dosing
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Open Arm |
All patients will receive cyclophosphamide on Day +3 and Day +4 following transplant. |
|
Recruiting Locations
Los Angeles, California 90048
More Details
- Status
- Recruiting
- Sponsor
- Ronald Paquette
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.