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NCT01116232 · ClinicalTrials.gov registry record · Phase 2

Sirolimus, Tacrolimus, Thymoglobulin and Rituximab as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Haploidentical and HLA Partially Matched Donor Hematopoietic Cell Transplantation

A Phase 2 study, sponsored by Barbara Ann Karmanos Cancer Institute.

Terminated
Registry status
Phase 2
Development phase
4
Enrollment target

NCT01116232: Clinical Trial Phase 2 study, sponsored by Barbara Ann Karmanos Cancer Institute.

NCT01116232 is a Phase 2 study that was terminated before completion, run by Barbara Ann Karmanos Cancer Institute. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01116232, a Phase 2 study, was terminated before completion, sponsored by Barbara Ann Karmanos Cancer Institute.

TERMINATED
Registry status
Phase 2
Development phase
4 participants
Enrollment target

Study Summary

This Phase II clinical trial was designed for patients with hematologic malignancies in need of donor peripheral blood stem cell transplant, and have no HLA matched donor. Therefore It will test the efficacy of combining sirolimus, tacrolimus, antithymocyte globulin, and rituximab in preventing graft versus host disease in transplants from HLA Haploidentical and partially mismatched donors.

Interventions

  • OTHER laboratory biomarker analysis
  • BIOLOGICAL rituximab
  • DRUG tacrolimus
  • DRUG sirolimus
  • BIOLOGICAL anti-thymocyte globulin

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2010-08
Est. Completion 2013-06
Phase Phase 2

Why NCT01116232 stopped before completion

NCT01116232 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).

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

NCT01116232 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01116232 about?

NCT01116232 is a clinical study titled "Sirolimus, Tacrolimus, Thymoglobulin and Rituximab as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Haploidentical and HLA Partially Matched Donor Hematopoietic Cell Transplantation". This Phase II clinical trial was designed for patients with hematologic malignancies in need of donor peripheral blood stem cell transplant, and have no HLA matched donor. Therefore It will test the efficacy of combining sirolimus, tacrolimus, antithymocyte globulin, and rituximab in preventing graf...

What is the current status of trial NCT01116232?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2010-08. Estimated completion is 2013-06.

What interventions are being tested in trial NCT01116232?

The interventions under investigation include: laboratory biomarker analysis (OTHER), rituximab (BIOLOGICAL), tacrolimus (DRUG), sirolimus (DRUG), anti-thymocyte globulin (BIOLOGICAL).

Who is sponsoring clinical trial NCT01116232?

This trial is sponsored by Barbara Ann Karmanos Cancer Institute, which has 139 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01116232's enrollment target sits among peer trials

4 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 NCT01116232, the US trial registry maintained by the National Library of Medicine. NCT01116232 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.