Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation

A Phase II Trial of Reduced Intensity Fludarabine and Total Body Irradiation-Based Conditioning Prior to Haplo-Identical Transplantation for Patients With Hematologic Malignancies

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.

Study Overview

• Status: Recruiting
• Conditions: Hematologic Malignancy
• Intervention / Treatment: Other: Fludarabine

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Stacey Brown; Phone Number: 404-480-7965; Email: stacey.brown@northside.com
• Study Contact Backup: Name: Caitlin Guzowski; Phone Number: 404-851-8523; Email: Caitlin.Guzowski@northside.com

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Recruiting
      • Caitlin Guzowski
      • Sub-Investigator: Lizamarie Bachier-Rodriguez, MD
      • Sub-Investigator: Scott Solomon, MD
      • Contact: Caitlin Guzowski, MBA, MHA; Phone Number: 404-851-8523; Email: caitlin.guzowski@northside.com
      • Principal Investigator: Melhem Solh, MD
      • Sub-Investigator: H. Kent Holland, MD
      • Sub-Investigator: Asad Bashey, MD
      • Sub-Investigator: Lawrence E Morris, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Northside Hospital, Inc.
• Investigators: Principal Investigator: Scott Solomon, MD, BMTGA

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2022
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms; Antineoplastic Agents; Fludarabine
• Other Study ID Numbers: NSH 1347

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No