Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation for Hematologic Malignancy

This study is looking at a treatment approach for people with blood cancers (hematologic malignancy) that need a stem cell transplant. It's testing the safety and effectiveness of a specific transplant method called RIC HIDT, which uses a reduced dose of fludarabine and intermediate-dose total body irradiation (TBI) before a haplo-identical (partially matched) stem cell transplant. You might be able to join if you are 18 or older, have a good performance status (KPS ≥ 70%), and have a partially matched family donor. The study will measure how quickly your white blood cells (neutrophils) and platelets recover after the transplant, and look for signs of graft rejection within 30 days. The current status of this study is unclear.

Study design
This is an observational study with a planned enrollment of 20 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure outcomes for at least 30 days after transplant to determine the incidence of graft rejection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05417971

Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation

Recruiting
Not specifiedAges 18+Observational
Northside Hospital, Inc.
~20 participants
Updated 2026-04-16 on ClinicalTrials.gov
What's tested:Fludarabine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Compare the time to recovery of circulating neutrophils and platelets of all patients to determine incidence of graft rejection
Measured over 30 days after transplant
Hematologic Malignancy

NCT05417971

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Caitlin Guzowski

    Atlanta, Georgiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Scott Solomon, MD · PRINCIPAL_INVESTIGATOR · BMTGA

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Eligibility criteria

Inclusion

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

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
  • Compare the time to recovery of circulating neutrophils and platelets of all patients to determine incidence of graft rejection30 days after transplant