NCT05417971 Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation
| NCT ID | NCT05417971 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northside Hospital, Inc. |
| Condition | Hematologic Malignancy |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-08-29 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2022-08-29 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Scott Solomon, MD
PRINCIPAL INVESTIGATOR
BMTGA
Frequently Asked Questions
Who can join the NCT05417971 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hematologic Malignancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05417971 currently recruiting?
Yes, NCT05417971 is actively recruiting participants. Contact the research team at stacey.brown@northside.com for enrollment information.
Where is the NCT05417971 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT05417971 clinical trial?
NCT05417971 is sponsored by Northside Hospital, Inc.. The principal investigator is Scott Solomon, MD at BMTGA. The trial plans to enroll 20 participants.