RECRUITING

Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-08-29

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05417971

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Study Contact

Stacey Brown

CONTACT

404-480-7965

stacey.brown@northside.com

Caitlin Guzowski

CONTACT

404-851-8523

caitlin.guzowski@northside.com

Principal Investigator

Scott Solomon, MD

PRINCIPAL_INVESTIGATOR

BMTGA

Study Locations (Sites)

Caitlin Guzowski

Atlanta, Georgia, 30342

United States

Collaborators and Investigators

Sponsor: Northside Hospital, Inc.

Scott Solomon, MD, PRINCIPAL_INVESTIGATOR, BMTGA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-29

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2022-08-29

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

Hematologic Malignancy