NCT03399773

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

Active, enrolled Phase 2 Last updated 26 August 2025

What this trial tests

Phase 2 trial testing Dilanubicel in Acute Biphenotypic Leukemia in 31 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

10 May 2022

Primary endpoint
9 June 2025

2 April 2027

Quick facts

Lead sponsor	Fred Hutchinson Cancer Center
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	31
Start date	10 May 2022
Primary completion	9 June 2025
Estimated completion	2 April 2027
Sites	1 location across United States

Drugs / interventions tested

• Dilanubicel
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Fludarabine (FLUDARABINE) — full drug profile →
• Thiotepa — full drug profile →
• Total-Body Irradiation
• Umbilical Cord Blood Transplantation
• Laboratory Biomarker Analysis
• Biospecimen Collection — full drug profile →
• Bone Marrow Aspirate
• Bone Marrow Biopsy
• Multigated Acquisition Scan
• Electrocardiography
• Computed Tomography

Conditions studied

• Acute Biphenotypic Leukemia — all drugs for Acute Biphenotypic Leukemia →
• Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →
• Chronic Myelogenous Leukemia, BCR-ABL1 Positive — all drugs for Chronic Myelogenous Leukemia, BCR-ABL1 Positive →
• Hematopoietic and Lymphoid Cell Neoplasm — all drugs for Hematopoietic and Lymphoid Cell Neoplasm →

Sponsor

Fred Hutchinson Cancer Center — full company profile →

Who can join

Adults 10 to 65, any sex, with Acute Biphenotypic Leukemia or Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. In Vitro Human Haematopoietic Stem Cell Expansion and Differentiation.
   Bozhilov YK, Hsu I, Brown EJ, Wilkinson AC. · · 2023 · cited 38× · PMID 36980237 · DOI 10.3390/cells12060896
2. Umbilical cord blood derived cell expansion: a potential neuroprotective therapy.
   Penny TR, Jenkin G, Miller SL, McDonald CA. · · 2024 · cited 8× · PMID 39075614 · DOI 10.1186/s13287-024-03830-0