Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation

Description

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.

Conditions

Hematologic Malignancy

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Study Overview

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Study Details

Study overview

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.

A Phase II Trial of Reduced Intensity Fludarabine and Total Body Irradiation-Based Conditioning Prior to Haplo-Identical Transplantation for Patients With Hematologic Malignancies

Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation

Condition
Hematologic Malignancy
Intervention / Treatment

-

Contacts and Locations

Atlanta

Caitlin Guzowski, Atlanta, Georgia, United States, 30342

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Northside Hospital, Inc.,

Scott Solomon, MD, PRINCIPAL_INVESTIGATOR, BMTGA

Study Record Dates

2025-12-31