Clinical trial NCT05417971: Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematologic Malignancy
Lead sponsor: Northside Hospital, Inc.
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


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

Primary outcomes:
measure: Compare the time to recovery of circulating neutrophils and platelets of all patients to determine incidence of graft rejection
timeFrame: 30 days after transplant
Secondary outcomes:
measure: Number of patients who are still alive as assessed by survival status at certain timepoints after transplant
timeFrame: 36 months after transplant
measure: Number of patients with relapsed disease as assessed by labs, bone marrow biopsies and radiological scans at certain timepoints after transplant
timeFrame: 36 months after transplant
measure: Number of patients with evidence of graft versus host disease as assessed by weekly progress notes after transplant
timeFrame: 36 months after transplant
measure: Number of participants who died in the absence of relapse or progression as assessed by survival status at certain timepoints after transplant
timeFrame: 1 year after transplant
measure: Number of participants with responses to treatment as assessed by labs, bone marrow biopsies and radiological scans at certain timepoints after transplant
timeFrame: 36 months after transplant
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v.5.0
timeFrame: 90 days after transplant
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Caitlin Guzowski
state: Georgia
Study officials:
affiliation: BMTGA
name: Scott Solomon, MD
role: PRINCIPAL_INVESTIGATOR
References: