OncRef

Clinical Trial: NCT02094794

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:City of Hope Medical Center
Information Provided By:City of Hope Medical Center
Last Update Posted:2026-07-01

Study Overview

Brief 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

Conditions

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia

Intervention / Treatment

  • Drug: etoposide
  • Drug: cyclophosphamide
  • Radiation: total marrow irradiation
  • Procedure: allogeneic hematopoietic stem cell transplantation
  • Procedure: allogeneic bone marrow transplantation

Other Study ID Numbers

  • 14012
  • NCI-2014-00639
  • 14012
  • R01CA154491

Start Date (Actual)

2014-05-12

Primary Completion Date (Estimated)

2027-05-04

Study Completion Date (Estimated)

2027-05-04

Enrollment (Actual)

108

Study Type

Interventional

Phase

Phase 2