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NCT01749293 · ClinicalTrials.gov registry record · Phase 2

Partially HLA Mismatched (Haploidentical) Allogeneic Bone Marrow Transplantation

A Phase 2 study, sponsored by University of Illinois at Chicago.

Terminated
Registry status
Phase 2
Development phase
3
Enrollment target

NCT01749293: Clinical Trial Phase 2 study, sponsored by University of Illinois at Chicago.

NCT01749293 is a Phase 2 study that was terminated before completion, run by University of Illinois at Chicago. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01749293, a Phase 2 study, was terminated before completion, sponsored by University of Illinois at Chicago.

TERMINATED
Registry status
Phase 2
Development phase
3 participants
Enrollment target

Study Summary

Allogeneic stem cell transplantation is a potentially curative treatment for patients with many hematologic malignancies (e.g. leukemia, lymphoma, and myeloma with high risk of relapse). This process requires a suitable donor. The best case scenario involves an Human Leukocyte Antigen (HLA) matched sibling donor. However, this type of donor is not always available. Donor registries can provide another source for matched unrelated donors, but this may take valuable time delaying treatment for the transplant recipient. Donor availability remains a significant barrier to the use of allogeneic (from a donor) stem cell transplant. This issue disproportionately affects patients of minority backgrounds. Novel strategies to improve outcomes using alternative donors are desperately needed. Haploidentical transplants are an alternative which provides a readily available donor in the form of a partially HLA matched family member. This provides for more potential donors and the donors can be selected based on other factors that can play a role in transplant success (e.g. age, gender, KIR alloreactivity). Recent advances in transplant techniques have greatly improved success rates with haploidentical transplants although disease relapse has remained as issue. This trial aims to provide an alternative transplant option for patients with hematologic malignancies who require bone marrow transplantation but lack an HLA identical donor. The investigational component of this study is the combination of the Fludarabine/ Busulfan/ Total Body Irradiation conditioning regimen and the HLA Haploidentical Transplant with post-transplant Cyclophosphamide.

Primary Outcome

To estimate the number of participants that had engraftment rates and the number of participants that had full donor chimerism at Day 60 in patients undergoing an HLA haploidentical stem cell transplant with post transplant high dose cyclophosphamide.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • DRUG Busulfan
  • RADIATION Total Body Irradiation
  • PROCEDURE Haploidentical Transplant

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2012-08-30
Est. Completion 2014-05-15
Phase Phase 2
University of Illinois at Chicago

430 total trials

Why NCT01749293 stopped before completion

NCT01749293 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).

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

NCT01749293 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01749293 about?

NCT01749293 is a clinical study titled "Partially HLA Mismatched (Haploidentical) Allogeneic Bone Marrow Transplantation". Allogeneic stem cell transplantation is a potentially curative treatment for patients with many hematologic malignancies (e.g. leukemia, lymphoma, and myeloma with high risk of relapse). This process requires a suitable donor. The best case scenario involves an Human Leukocyte Antigen (HLA) matched ...

What is the current status of trial NCT01749293?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2012-08-30. Estimated completion is 2014-05-15.

What interventions are being tested in trial NCT01749293?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Busulfan (DRUG), Total Body Irradiation (RADIATION), Haploidentical Transplant (PROCEDURE).

Who is sponsoring clinical trial NCT01749293?

This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01749293's enrollment target sits among peer trials

3 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 NCT01749293, the US trial registry maintained by the National Library of Medicine. NCT01749293 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.