Clinical Trial

Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies

Recruiting Phase 2

Summary

This phase II trial studies how well a donor stem cell transplant, treosulfan, fludarabine, and total-body irradiation work in treating patients with blood cancers (hematological malignancies). Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.

Protocol Amendment History 32 amendments

This ClinicalTrials.gov record has been amended 32 times since 2019-12-10; most recent amendment 2026-05-27.

Status change: Suspended → Recruiting 2022-02-23

Status change: Recruiting → Suspended 2021-12-16

Status change: Not Yet Recruiting → Recruiting 2020-12-09

Trial Details

NCT Number	NCT04195633
Lead Sponsor	Fred Hutchinson Cancer Center Collaborators: medac GmbH
Conditions	Acute Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Adult Diffuse Large Cell Lymphoma, Anaplastic Large Cell Lymphoma, Burkitt Lymphoma, Chronic Myeloid Leukemia, BCR-ABL1 Positive, Chronic Myelomonocytic Leukemia +11 more
Enrollment	60 participants
Start Date	2021-01-25
Primary Completion	2027-04-15 (estimated)
Study Completion	2029-03-12 (estimated)
Updated on ClinicalTrials.gov	2026-05-29