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ACTIVE NOT RECRUITING
NCT03399773
PHASE2

Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes

Sponsor: Fred Hutchinson Cancer Center

View on ClinicalTrials.gov

Summary

This phase II trial studies how well donor umbilical cord blood transplant with ex-vivo expanded cord blood progenitor cells (dilanubicel) works in treating patients with blood cancer. Before the transplant, patients will receive chemotherapy (fludarabine, cyclophosphamide and in some cases thiotepa) and radiation therapy. Giving chemotherapy and total-body irradiation before a donor umbilical cord blood 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.

Official title: Pilot Study: Infusion of Off-the-Shelf Ex Vivo Expanded Cryopreserved Progenitor Cells (Dilanubicel) in the Setting of Single Cord Blood Transplantation for Patients With Hematologic Malignancies

Key Details

Gender

All

Age Range

10 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

31

Start Date

2022-05-10

Completion Date

2027-04-02

Last Updated

2025-08-26

Healthy Volunteers

No

Interventions

BIOLOGICAL

Dilanubicel

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine

Given IV

DRUG

Thiotepa

Given IV

RADIATION

Total-Body Irradiation

Undergo TBI

PROCEDURE

Umbilical Cord Blood Transplantation

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspirate

Undergo bone marrow aspirate and biopsy

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow aspirate and biopsy

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

PROCEDURE

Electrocardiography

Undergo ECHO

PROCEDURE

Computed Tomography

Undergo CT

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States