Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation

NCT05417971 | Recruiting

• 1 other identifier: NSH 1347
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Malignancy

Outcome Measures

Primary Outcomes (1)

• Compare the time to recovery of circulating neutrophils and platelets of all patients to determine incidence of graft rejection

  30 days after transplant

Secondary Outcomes (6)

• Number of patients who are still alive as assessed by survival status at certain timepoints after transplant

  36 months after transplant

• Number of patients with relapsed disease as assessed by labs, bone marrow biopsies and radiological scans at certain timepoints after transplant

  36 months after transplant

• Number of patients with evidence of graft versus host disease as assessed by weekly progress notes after transplant

  36 months after transplant

• Number of participants who died in the absence of relapse or progression as assessed by survival status at certain timepoints after transplant

  1 year after transplant

• Number of participants with responses to treatment as assessed by labs, bone marrow biopsies and radiological scans at certain timepoints after transplant

  36 months after transplant

Interventions

Fludarabine OTHER

Reduced-intensity fludarabine with intermediate-dose TBI

Also known as: Total Body Irradiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male or female patients with any hematologic malignancy that requires an allogeneic transplant from a halpo-identical matched related donor

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northside Hospital, Inc.: lead

Study Sites (1)

Caitlin Guzowski

Atlanta, Georgia, 30342, United States

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

fludarabine; Whole-Body Irradiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Investigative Techniques

Study Officials

• Scott Solomon, MD

  BMTGA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stacey Brown

CONTACT

404-480-7965; stacey.brown@northside.com

Caitlin Guzowski

CONTACT

404-851-8523; caitlin.guzowski@northside.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 14, 2022
• Study Start: August 29, 2022
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)