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

RECRUITINGPhase 1Sponsored by Ronald Paquette
Actively Recruiting
PhasePhase 1
SponsorRonald Paquette
Started2023-10-24
Est. completion2027-07-01
Eligibility
Age65 Years+
Healthy vol.Accepted
Locations1 site

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

Age: 65 Years+Healthy volunteers accepted
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.

Conditions2

CancerHematologic Malignancies

Locations1 site

Cedars-Sinai Medical Center
Los Angeles, California, 90048
Clinical Trial Recruitment Navigator13104232133cancer.trial.info@cshs.org

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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