Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation
NCT ID: NCT05417971
Last Updated: 2025-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2022-08-29
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Fludarabine
Reduced-intensity fludarabine with intermediate-dose TBI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* KPS \>/= 70%
* Hematologic malignancy requiring allogeneic transplantation, with a predicted high risk of relapse following non-myeloablative, low intensity conditioning.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Northside Hospital, Inc.
OTHER
Responsible Party
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Principal Investigators
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Scott Solomon, MD
Role: PRINCIPAL_INVESTIGATOR
BMTGA
Locations
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Caitlin Guzowski
Atlanta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NSH 1347
Identifier Type: -
Identifier Source: org_study_id
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