Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05417971 | RECRUITING | Hematologic Malignancy

Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation
Sponsor:

Northside Hospital, Inc.

Brief Summary:

This trial will evaluate the safety and efficacy of RIC HIDT transplant protocol following fludarabine and intermediate-dose TBI 800 cGy utilizing PBSC as the stem cell source.

Condition or disease

Hematologic Malignancy

Intervention/treatment

Fludarabine

Study Type : OBSERVATIONAL
Estimated Enrollment : 20 participants
Official Title : A Phase II Trial of Reduced Intensity Fludarabine and Total Body Irradiation-Based Conditioning Prior to Haplo-Identical Transplantation for Patients With Hematologic Malignancies
Actual Study Start Date : 2022-08-29
Estimated Primary Completion Date : 2026-07-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Availability of 3/6 - 5/6 matched related donor with a negative HLA-cross match in the host vs. graft direction willing to donate peripheral blood stem cells
  • * KPS \>/= 70%
  • * Hematologic malignancy requiring allogeneic transplantation, with a predicted high risk of relapse following non-myeloablative, low intensity conditioning.
Exclusion Criteria
  • * Poor cardiac function (LVEF \<45%)
  • * Poor pulmonary function (FEV, FVC, DLCO \<60%)
  • * Poor liver function (bilirubin \>/= 2.5mg/dL; AST or ALT \>3xULN)
  • * Poor renal function (creatinine clearance \<40mL/min)
  • * HIV-positive; active HepB or HepC
  • * Uncontrolled infection
  • * Pregnant female or not able to practice adequate contraception
  • * Debilitating medical or psychiatric illness which would preclude their giving informed consent
Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation

Location Details

NCT05417971

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Georgia

Caitlin Guzowski

Atlanta, Georgia, United States, 30342