Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation

Sponsor

Northside Hospital, Inc. (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05417971

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematologic Malignancy	Other: Fludarabine

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Northside Hospital, Inc.

Investigators

Principal Investigator: Scott Solomon, MD, BMTGA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Scott Solomon, Principal Investigator, Northside Hospital, Inc.

ClinicalTrials.gov Identifier:

NCT05417971

Other Study ID Numbers:

NSH 1347

First Posted:

Jun 14, 2022

Last Update Posted:

Jun 14, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Hematologic Neoplasms

Fludarabine

Study Results

No Results Posted as of Jun 14, 2022