Clinical trial NCT05849207: Post-Transplant Cyclophosphamide in Patients Aged >/= 65 Years Undergoing Haploidentical Transplant
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hematologic Malignancies
Keywords: Allogeneic Transplantation
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 26
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Open-label trial

De-escalation of post-transplant cyclophosphamide dosing
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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
* 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.

Primary outcomes:
measure: Maximum grade acute GVHD by day +100 by Modified Keystone Criteria
timeFrame: 100 days post-transplant
Secondary outcomes:
measure: Time to neutrophil and platelet engraftment
timeFrame: 60 days post-transplant
measure: Non-Relapse mortality
timeFrame: 100 days post-transplant
measure: Chronic Graft Versus Host Disease (GVHD) at 1 year
timeFrame: 1-year post-transplant
measure: Relapse
timeFrame: 1-year post-transplant
measure: Overall Survival (OS)
timeFrame: 1-year post-transplant
measure: Graft Versus Host Disease (GVHD)-free and Relapse Free Survival
timeFrame: 1-year post- transplant
measure: Change in cardiac function
timeFrame: From 60 days prior to transplant to 365 days post-transplant
measure: Change in active daily living
timeFrame: From 60 days prior to transplant to 365 days post-transplant
measure: Change in function
timeFrame: From 60 days prior to transplant to 365 days post-transplant
measure: Change in pain
timeFrame: From 60 days prior to transplant to 365 days post-transplant
measure: Change in physical function
timeFrame: From 60 days prior to transplant to 365 days post-transplant
measure: Change in grip strength
timeFrame: From 60 days prior to transplant to 365 days post-transplant
measure: Change in cognitive function
timeFrame: From 60 days prior to transplant to 365 days post-transplant
measure: Change in mental health
timeFrame: From 60 days prior to transplant to 365 days post-transplant
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Ronald Paquette, MD
role: PRINCIPAL_INVESTIGATOR
References: