RecruitingPhase 2NCT04195633

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

Hematopoietic Stem Cell Transplantation From Haploidentical Donors in Patients With Hematological Malignancies Using a Treosulfan-Based Preparative Regimen

Sponsor

Fred Hutchinson Cancer Center

Enrollment

60 participants

Start Date

Jan 25, 2021

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Hodgkin Lymphoma Myelodysplastic Syndrome Acute Leukemia Mantle Cell Lymphoma Refractory Chronic Lymphocytic Leukemia Refractory Follicular Lymphoma Refractory Small Lymphocytic Lymphoma Chronic Myelomonocytic Leukemia Mixed Phenotype Acute Leukemia Lymphoblastic Lymphoma Burkitt Lymphoma Anaplastic Large Cell Lymphoma Lymphoplasmacytic Lymphoma Prolymphocytic Leukemia Adult Diffuse Large Cell Lymphoma Chronic Myeloid Leukemia, BCR-ABL1 Positive Refractory Marginal Zone Lymphoma

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.

Eligibility

Min Age: 6 Months

Plain Language Summary

Simplified for easier understanding

This study is testing a stem cell transplant procedure using a specific conditioning regimen (treosulfan, fludarabine, and thiotepa) in patients with leukemia or other blood cancers, to see if it can produce remission while reducing serious side effects. **You may be eligible if...** - You have acute leukemia (AML, ALL, or mixed type) currently in remission - You have chronic myelogenous leukemia (CML) that has failed or you cannot tolerate tyrosine kinase inhibitors - You have chronic myelomonocytic leukemia (CMML) or myelodysplastic syndrome (MDS) - You need a stem cell transplant from a donor **You may NOT be eligible if...** - Your leukemia is in an active blast crisis that is refractory - You are not a candidate for stem cell transplantation based on your overall health - You have not yet achieved remission from your leukemia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAllogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic hematopoietic stem cell transplantation

DRUGCyclophosphamide

Given IV

DRUGCyclosporine

Given IV or PO

BIOLOGICALFilgrastim

Given IV

DRUGFludarabine

Given IV

DRUGMycophenolate Mofetil

Given IV or PO

DRUGMycophenolate Sodium

Given PO

RADIATIONTotal-Body Irradiation

Undergo total-body irradiation

DRUGTreosulfan

Given IV

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREEchocardiography Test

Undergo echocardiography

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT or PET/CT

PROCEDUREPositron Emission Tomography

Undergo PET/CT

Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT04195633

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