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

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.

Conditions

• Acute Biphenotypic Leukemia
• Acute Lymphoblastic Leukemia
• Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Hematopoietic and Lymphoid Cell Neoplasm
• Myelodysplastic Syndrome
• Myelodysplastic Syndrome With Excess Blasts

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

Sponsors & Collaborators

• Nohla Therapeutics, Inc.

  collaborator INDUSTRY

• National Cancer Institute (NCI)

  collaborator NIH

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

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

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

10 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-10

Primary Completion

2025-06-09

Completion

2027-04-02

FDA Drug

Yes

Countries

• United States

Study Locations