Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation

NCT ID: NCT05417971

Last Updated: 2025-10-30

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-29

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hematologic Malignancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Fludarabine

Reduced-intensity fludarabine with intermediate-dose TBI

Intervention Type OTHER

Other Intervention Names

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Total Body Irradiation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northside Hospital, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott Solomon, MD

Role: PRINCIPAL_INVESTIGATOR

BMTGA

Locations

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Caitlin Guzowski

Atlanta, Georgia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Stacey Brown

Role: CONTACT

404-480-7965

Caitlin Guzowski

Role: CONTACT

404-851-8523

Facility Contacts

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Caitlin Guzowski, MBA, MHA

Role: primary

404-851-8523

Other Identifiers

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NSH 1347

Identifier Type: -

Identifier Source: org_study_id

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