NCT04083170

Cord Blood Transplant With Dilanubicel for the Treatment of HIV Positive Hematologic Cancers

Infusion of Off-the-Shelf Ex Vivo Expanded Cryopreserved Progenitor Cells to Facilitate the Engraftment of a Single CCR5Δ32 Homozygous or Heterozygous Cord Blood Unit in Patients With HIV and Hematological Malignancies

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 6 Months – 65 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the side effects of a cord blood transplant using dilanubicel and to see how well it works in treating patients with human immunodeficiency virus (HIV) positive hematologic (blood) cancers. After a cord blood transplant, the immune cells, including white blood cells, can take a while to recover, putting the patient at increased risk of infection. Dilanubicel consists of blood stem cells that help to produce mature blood cells, including immune cells. Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Total body irradiation is a type of whole-body radiation. Giving chemotherapy and total-body irradiation before a cord blood transplant with dilanubicel may help to kill any cancer cells that are in the body and make room in the patient's bone marrow for new stem cells to grow and reduce the risk of infection.

Detailed description

OUTLINE: Patients are assigned to 1 of 2 regimens. REGIMEN A: Patients receive fludarabine intravenously (IV) over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6, and undergo total body irradiation (TBI) twice daily (BID) on days -4 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. REGIMEN B: Patients receive fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 4 hours on days -5 to -4, and undergo TBI once daily (QD) on days -2 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 28, 80, and 180 days, and then at 1 and 2 years.

Conditions

• Acute Erythroid Leukemia
• Acute Lymphoblastic Leukemia
• Acute Megakaryoblastic Leukemia
• Acute Myeloid Leukemia
• Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Hematopoietic and Lymphoid Cell Neoplasm
• HIV Infection
• Myelodysplastic Syndrome
• Myelodysplastic Syndrome With Excess Blasts
• Non-Hodgkin Lymphoma
• Refractory Anemia

Interventions

Type	Name	Description
DRUG	Fludarabine	Given IV
DRUG	Cyclophosphamide	Given IV
DRUG	Thiotepa	Given IV
RADIATION	Total-Body Irradiation	Undergo TBI
PROCEDURE	Umbilical Cord Blood Transplantation	Undergo UCBT
BIOLOGICAL	Dilanubicel	Given IV

Timeline

• Start date: 2022-10-06
• Primary completion: 2022-11-11
• Completion: 2022-11-30
• First posted: 2019-09-10
• Last updated: 2025-01-01
• Results posted: 2025-01-01

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study