Hematologic Malignancy
Conditions
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.
Interventions
OTHERFludarabine
Reduced-intensity fludarabine with intermediate-dose TBI
Sponsors
Northside Hospital, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the time to recovery of circulating neutrophils and platelets of all patients to determine incidence of graft rejection | 30 days after transplant |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Number of participants with treatment-related adverse events as assessed by CTCAE v.5.0 | 90 days after transplant |
Countries
United States
Contacts
CONTACTStacey Brown
CONTACTCaitlin Guzowski
PRINCIPAL_INVESTIGATORScott Solomon, MD
BMTGA
Outcome results
None listed