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RECRUITING
NCT05031897
PHASE2

Two Step Haplo With Radiation Conditioning

Sponsor: Thomas Jefferson University

View on ClinicalTrials.gov

Summary

This phase II clinical trial evaluates whether a modified modality of conditioning reduces treatment-related mortality (TRM) in patients who undergo a hematopoietic stem cell transplant (HSCT) for a hematological malignancy. HSCT is a curative therapy for many hematopoietic malignancies, however this regimen results in higher rates of TRM than other forms of treatment. In recent years, less intense conditioning regimens with radiation and chemotherapy prior to HSCT have been developed. Radiation therapy uses high energy sources to kill cancer cells and shrink tumors while chemotherapy drugs like fludarabine and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study evaluates whether a two-step approach with lower-intensity regimens of these treatments prior to HSCT reduces the rate of TRM.

Official title: A 2 Step Approach to Haploidentical Transplant Using Radiation-Based Reduced Intensity Conditioning

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

63

Start Date

2021-10-25

Completion Date

2032-04

Last Updated

2025-10-30

Healthy Volunteers

No

Interventions

DRUG

Fludarabine

Given IV

RADIATION

Total-Body Irradiation

Undergo TBI

PROCEDURE

Donor Lymphocyte Infusion

Undergo DLI

DRUG

Cyclophosphamide

Given IV

DRUG

Tacrolimus

Given IV

DRUG

Mycophenolate Mofetil

Given IV

PROCEDURE

Hematopoietic Cell Transplantation

Undergo HSCT

DRUG

Melphalan

Given IV

PROCEDURE

Bone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration/ biopsy

PROCEDURE

Diagnostic Imaging

Undergo diagnostic imaging

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Locations (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadephia, Pennsylvania, United States