drugset / Trial / NCT04083170

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

NCT04083170 ↗

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-10-06
Primary completion
2022-11-11
Completion
2022-11-30

Outcome

Outcome not reported

Stopped (Enrollment): “The federal funding period ended. The study was originally intended to be multi-site but was only conducted at the lead site. Due to the rarity of the subject population \& smaller # of enrolling sites, we were not able to reach accrual goals.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified — Intravenous
Subject Dilanubicel Cell therapy — Intravenous
Subject Fludarabine Small molecule — Intravenous
Subject Thiotepa Other / unclassified — Intravenous