Recruiting NCT05417971
Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fludarabine.
- Who it may be relevant to
- Registry conditions: Hematologic Malignancy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase II Trial of Reduced Intensity Fludarabine and Total Body Irradiation-Based Conditioning Prior to Haplo-Identical Transplantation for Patients With Hematologic Malignancies
Overview
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.
Interventions
- Other Fludarabine
Reduced-intensity fludarabine with intermediate-dose TBI
Primary outcome measures
- 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]
Secondary outcome measures (6)
- Number of patients who are still alive as assessed by survival status at certain timepoints after transplant [Time frame: 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 [Time frame: 36 months after transplant]
- Number of patients with evidence of graft versus host disease as assessed by weekly progress notes after transplant [Time frame: 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 [Time frame: 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 [Time frame: 36 months after transplant]
- Number of participants with treatment-related adverse events as assessed by CTCAE v.5.0 [Time frame: 90 days after transplant]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Caitlin Guzowski — Atlanta
Identifiers
NCT: NCT05417971 · NSH 1347