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ACTIVE NOT RECRUITING
NCT02094794
PHASE2

Total Marrow and Lymphoid Irradiation and Chemotherapy Before DSCT in Treating Patients With High-Risk ALL or AML

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

Summary

This phase II trial studies the safety and efficacy of total marrow and lymphoid irradiation (TMLI) in combination with two chemotherapy drugs, etoposide and cyclophosphamide, as a preparative regimen before donor stem cell transplant in treating patients with high-risk acute lymphocytic leukemia (ALL) or acute myeloid leukemia (AML) who have failed previous therapy. Intensity-modulated radiation therapy (IMRT) uses imaging to provide a three-dimensional view of the area to be irradiated. Doctors can then shape and direct the radiation beams at the area from multiple directions while avoiding, as much as possible, nearby organs. TMLI is a method of using IMRT to direct radiation to the bone marrow. Radiation therapy is given before transplant to suppress the immune system, prevent rejection of the transplanted cells, and wipe out any remaining cancer cells. TMLI may allow a greater radiation dose to be delivered to the bone marrow as a preparative regimen before transplant while causing fewer side effects than standard radiation therapy.

Official title: Phase II Study of Total Marrow and Lymphoid Irradiation (TMLI) Given in Combination With Cyclophosphamide and Etoposide as Conditioning for Allogeneic (HSCT) in Patients With High-Risk Acute Lymphocytic or Myelogenous Leukemia

Key Details

Gender

All

Age Range

16 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2014-05-12

Completion Date

2026-05-26

Last Updated

2025-07-18

Healthy Volunteers

No

Interventions

DRUG

etoposide

Given IV

DRUG

cyclophosphamide

Given IV

RADIATION

total marrow irradiation

Undergo TMLI

PROCEDURE

allogeneic hematopoietic stem cell transplantation

Undergo allogeneic peripheral blood stem cell or bone marrow transplant

PROCEDURE

allogeneic bone marrow transplantation

Undergo allogeneic peripheral blood stem cell or bone marrow transplant

Locations (1)

City of Hope Medical Center

Duarte, California, United States