Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation

Hematologic Malignancy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05417971
• Other study ID #: NSH 1347
• Status: Recruiting
• Start date: August 29, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Northside Hospital, Inc.
• Contact: Stacey Brown
• Phone: 404-480-7965
• Email: stacey.brown[@]northside.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms
• Neoplasms

Intervention

Other:
• Fludarabine
Reduced-intensity fludarabine with intermediate-dose TBI

Locations

Country	Name	City	State
United States	Caitlin Guzowski	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Northside Hospital, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the time to recovery of circulating neutrophils and platelets of all patients to determine incidence of graft rejection		30 days after transplant
Secondary	Number of patients who are still alive as assessed by survival status at certain timepoints after transplant		36 months after transplant
Secondary	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
Secondary	Number of patients with evidence of graft versus host disease as assessed by weekly progress notes after transplant		36 months after transplant
Secondary	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
Secondary	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
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v.5.0		90 days after transplant