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

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.

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
• Hodgkin Lymphoma
• Lymphoblastic Lymphoma
• Lymphoplasmacytic Lymphoma
• Mantle Cell Lymphoma
• Mixed Phenotype Acute Leukemia
• Myelodysplastic Syndrome
• Prolymphocytic Leukemia
• Refractory Chronic Lymphocytic Leukemia
• Refractory Follicular Lymphoma
• Refractory Marginal Zone Lymphoma
• Refractory Small Lymphocytic Lymphoma

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic hematopoietic stem cell transplantation

DRUG

Cyclophosphamide

Given IV

DRUG

Cyclosporine

Given IV or PO

BIOLOGICAL

Filgrastim

Given IV

DRUG

Fludarabine

Given IV

DRUG

Mycophenolate Mofetil

Given IV or PO

DRUG

Mycophenolate Sodium

Given PO

RADIATION

Total-Body Irradiation

Undergo total-body irradiation

DRUG

Treosulfan

Given IV

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDURE

Echocardiography Test

Undergo echocardiography

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

Sponsors & Collaborators

• medac GmbH

  collaborator INDUSTRY

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Filippo Milano · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-01-25

Primary Completion

2027-04-15

Completion

2029-03-12

FDA Drug

Yes

Countries

• United States

Study Locations