Post-Transplant Cyclophosphamide

What is the Purpose of this Study?

The purpose of this study is to determine the best dose of an immune suppressive drug, cyclophosphamide, following standard stem cell transplant in older patients (at least 65 years old). Participants will undergo a stem cell transplant with cells from a related donor and will receive a standard or reduced dose of cyclophosphamide that is routinely administered after a transplant procedure. They will also undergo heart MRI scans and complete a series of assessments of physical and cognitive function. The study will perform the transplant process as would be done routinely, except a reduced dose of cyclophosphamide will be given to some transplant patients and standard doses to other patients in order to determine whether lower doses can be safe and effective. Researchers also want to learn what happens when young stem cells are transplanted into older bone marrow recipients. Markers of aging will be studied on the stem cells and bone marrow before and after the transplant procedure. The U.S. Food and Drug Administration (FDA) approved cyclophosphamide for treating various conditions, but its use in transplant, while standard for many years, has not been approved.


Eligibility

  • * Patient age \>/= 70 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
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Where can I participate?

Cedars-Sinai Cancer at SOCC : Amy Oppenheim

More about this Clinical Trial

What is the full name of this clinical trial?

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 Details
Disease Type/Condition

Hodgkin's Lymphoma, Leukemia, not otherwise specified, Leukemia, other, Lymphoid Leukemia, Multiple Myeloma, Myeloid and Monocytic Leukemia, Non-Hodgkin's Lymphoma, Other Hematopoietic

Principal Investigator

Paquette, Ronald

Co-Investigators

Akil Merchant, Alan Kwan, Arash Asher, Hannah Lee, Joshua Sasine, Justin Darrah, Noah Merin, Philip Chang, Stephen Shiao

Age Group

Adult

Phase

I

IRB Number

STUDY00002709

ClinicalTrials.gov ID

NCT05849207

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Amy Oppenheim

Phone
+1 310-423-3713
Email
amy.oppenheim@cshs.org
Study Detail
Disease Type/Condition

Hodgkin's Lymphoma, Leukemia, not otherwise specified, Leukemia, other, Lymphoid Leukemia, Multiple Myeloma, Myeloid and Monocytic Leukemia, Non-Hodgkin's Lymphoma, Other Hematopoietic

Principal Investigator

Paquette, Ronald

Age Group

Adult

Phase

I

IRB Number

IIT2022-03-PAQUETTE-GERIBMT

ClinicalTrials.gov ID

NCT05849207

Key Eligibility
ClinicalTrials.gov

Contact
Name

Amy Oppenheim

Phone
+1 310-423-3713
Email
amy.oppenheim@cshs.org