Trial Title:
Post-Transplant Cyclophosphamide in Patients Aged >/= 65 Years Undergoing Haploidentical Transplant
NCT ID:
NCT05849207
Condition:
Hematologic Malignancies
Conditions: Official terms:
Hematologic Neoplasms
Cyclophosphamide
Conditions: Keywords:
Allogeneic Transplantation
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
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)
Intervention:
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Cyclophosphamide will be administered at 50, 40, 32, or 25 mg/k/d intravenous infusion
(IV) continuously for two days starting 60-72 hours after transplant.
Arm group label:
Open Arm
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patient age >/= 65 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.
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cedars-Sinai Medical Center
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amy Oppenheim
Phone:
310-423-3713
Email:
Amy.Oppenheim@cshs.org
Contact backup:
Last name:
Nadia Nassaj
Phone:
310-423-7735
Email:
mehrnoosh.nassaj@cshs.org
Investigator:
Last name:
John Chute, MD
Email:
Sub-Investigator
Investigator:
Last name:
Justin Darrah, MD
Email:
Sub-Investigator
Investigator:
Last name:
Akil Merchant, MD
Email:
Sub-Investigator
Investigator:
Last name:
Noah Merin, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Joshua Sasine, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Robert Vescio, MD
Email:
Sub-Investigator
Investigator:
Last name:
Arash Asher, MD
Email:
Sub-Investigator
Investigator:
Last name:
Philip Chang, MD
Email:
Sub-Investigator
Investigator:
Last name:
Alan Kwan, MD
Email:
Sub-Investigator
Investigator:
Last name:
Stephen Shiao, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Hannah Lee, MD
Email:
Sub-Investigator
Start date:
October 24, 2023
Completion date:
July 1, 2028
Lead sponsor:
Agency:
Ronald Paquette
Agency class:
Other
Source:
Cedars-Sinai Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05849207
