NCT05417971 · Northside Hospital, Inc.
Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation
What this study is about
This trial will evaluate the safety and effectiveness of RIC HIDT transplant protocol following fludarabine and intermediate-dose TBI 800 cGy utilizing PBSC as the stem cell source.
View original scientific 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.
Interventions
OTHER
Fludarabine
Reduced-intensity fludarabine with intermediate-dose TBI
Primary outcome measures
Compare the time to recovery of circulating neutrophils and platelets of all patients to determine incidence of graft rejection
Time frame: 30 days after transplant
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Atlanta, Georgia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 16, 2026 · Source of record for eligibility and locations