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NCT04083170 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Fred Hutchinson Cancer Center.

Terminated
Registry status
Phase 2
Development phase
1
Enrollment target

NCT04083170: Clinical Trial Phase 2 study, sponsored by Fred Hutchinson Cancer Center.

NCT04083170 is a Phase 2 study that was terminated before completion, run by Fred Hutchinson Cancer Center. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04083170, a Phase 2 study, was terminated before completion, sponsored by Fred Hutchinson Cancer Center.

TERMINATED
Registry status
Phase 2
Development phase
1 participants
Enrollment target

Study 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.

Primary Outcome

Will be defined by no neutrophil recovery by day 45 (regardless of donor chimerism) or autologous recovery (neutrophil recovery but \< 10% donor chimerism in blood and bone marrow) by day 36. This outcome was originally intended to be assessed for per the aforementioned definitions, but was only able to be assessed through 35 days post-transplant.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • RADIATION Total-Body Irradiation
  • DRUG Thiotepa
  • PROCEDURE Umbilical Cord Blood Transplantation

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2022-10-06
Est. Completion 2022-11-30
Phase Phase 2
Fred Hutchinson Cancer Center

483 total trials

Why NCT04083170 stopped before completion

NCT04083170 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT04083170 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04083170 about?

NCT04083170 is a clinical study titled "Cord Blood Transplant With Dilanubicel for the Treatment of HIV Positive Hematologic Cancers". 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 ...

What is the current status of trial NCT04083170?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2022-10-06. Estimated completion is 2022-11-30.

What interventions are being tested in trial NCT04083170?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Total-Body Irradiation (RADIATION), Thiotepa (DRUG), Umbilical Cord Blood Transplantation (PROCEDURE).

Who is sponsoring clinical trial NCT04083170?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04083170's enrollment target sits among peer trials

1 2001st of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04083170, the US trial registry maintained by the National Library of Medicine. NCT04083170 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.