Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation
Recruiting
- Conditions
- Hematologic Malignancy
- Registration Number
- NCT05417971
- Lead Sponsor
- Northside Hospital, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compare the time to recovery of circulating neutrophils and platelets of all patients to determine incidence of graft rejection 30 days after transplant
- Secondary Outcome Measures
Name Time Method Number of patients with evidence of graft versus host disease as assessed by weekly progress notes after transplant 36 months after transplant Number of patients who are still alive as assessed by survival status at certain timepoints after transplant 36 months 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 Number of participants with treatment-related adverse events as assessed by CTCAE v.5.0 90 days 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 participants who died in the absence of relapse or progression as assessed by survival status at certain timepoints after transplant 1 year after transplant
Trial Locations
- Locations (1)
Caitlin Guzowski
🇺🇸Atlanta, Georgia, United States