Recruiting

RIC HIDT

Sponsor:

Northside Hospital, Inc.

Code:

NCT05417971

Conditions

Hematologic Malignancy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fludarabine

Study Details

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

Study ID

NCT05417971

Start date

Aug 29, 2022

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Interventions

Fludarabine

Reduced-intensity fludarabine with intermediate-dose TBI

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Stacey Brown

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

Caitlin Guzowski

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

Locations

Caitlin Guzowski

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Caitlin Guzowski, MBA, MHA

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

Principal Investigator:

Melhem Solh, MD

More Information

Sponsor

Northside Hospital, Inc.

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northside Hospital, Inc. on 2026-04-16.