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ACTIVE NOT RECRUITING
NCT04262843
PHASE2

Total Marrow and Lymphoid Irradiation as Conditioning Regimen Before Hematopoietic Cell Transplantation in Patients With Myelodysplastic Syndrome or Acute Leukemia

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

Summary

This phase II trial studies how well total marrow and lymphoid irradiation works as a conditioning regimen before hematopoietic cell transplantation in patients with myelodysplastic syndrome or acute leukemia. Total body irradiation can lower the relapse rate but has some fatal side effects such as irreversible damage to normal internal organs and graft-versus-host disease (a complication after transplantation in which donor's immune cells recognize the host as foreign and attack the recipient's tissues). Total body irradiation is a form of radiotherapy that involves irradiating the patient's entire body in an attempt to suppress the immune system, prevent rejection of the transplanted bone marrow and/or stem cells and to wipe out any remaining cancer cells. Intensity-modulated radiation therapy (IMRT) is a more recently developed method of delivering radiation. Total marrow and lymphoid irradiation is a method of using IMRT to direct radiation to the bone marrow. Total marrow and lymphoid irradiation may allow a greater dose of radiation to be delivered to the bone marrow as a preparative regimen before hematopoietic cell transplant while causing less side effects to normal organs than standard total body irradiation.

Official title: Phase II Study of Evaluating the Efficacy of Total Marrow and Lymphoid Irradiation (TMLI) as the Conditioning Regimen for HLA-Haploidentical Hematopoietic Cell Transplantation in Patients With Myelodysplasia or Acute Leukemia

Key Details

Gender

All

Age Range

12 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2020-02-07

Completion Date

2026-06-23

Last Updated

2026-01-28

Healthy Volunteers

No

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine

Given IV

DRUG

Fludarabine Phosphate

Given IV

BIOLOGICAL

Granulocyte Colony-Stimulating Factor

Growth factor therapy

PROCEDURE

Hematopoietic Cell Transplantation

Undergo hematopoietic cell transplantation

PROCEDURE

Intensity-Modulated Radiation Therapy

Undergo TMLI

DRUG

Mycophenolate Mofetil

Immunosuppressive therapy

DRUG

Tacrolimus

Immunosuppressive therapy

Locations (1)

City of Hope Medical Center

Duarte, California, United States