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NCT01246206 · ClinicalTrials.gov registry record · Phase 2

Tacrolimus and Thymoglobulin, as GvHD Prophylaxis in Patients Undergoing Related Donor HCT

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

Completed
Registry status
Phase 2
Development phase
21
Enrollment target

NCT01246206 is a Phase 2 study that has completed, run by Barbara Ann Karmanos Cancer Institute. The registered enrollment target is 21 participants.

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The verdict

NCT01246206, a Phase 2 study, has completed, sponsored by Barbara Ann Karmanos Cancer Institute.

COMPLETED
Registry status
Phase 2
Development phase
21 participants
Enrollment target

Study Summary

The primary goal of the study is to determine the incidence and severity of acute Graft versus Host Disease (GVHD) following human leukocyte antigen (HLA) matched related donor Hematopoetic Stem Cell(HSC) transplant in patients with blood related cancers who receive the combination of tacrolimus and Thymoglobulin as GVHD prophylaxis. The investigators also will determine the safety of this combination in the first six months post transplant. Secondary goals include determining the time to recovery of white blood cells and platelets (engraftment), determining the occurrence of opportunistic infections, defined as infection that occurs in people with weakened immune systems and caused by organisms that do not normally cause disease (fungal infections, pneumocystis carinii pneumonia (PCP), and viral infections), estimating the incidence of chronic GVHD at two years and the overall and disease free survival at two years. Immune response will be assessed by means of immuno-correlative studies both prior to and at various points after transplant.

Interventions

  • DRUG Tacrolimus and Thymoglobulin

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2010-11
Est. Completion 2013-10
Phase Phase 2

What the Registry Record Tells You About NCT01246206

The ClinicalTrials.gov registry entry for NCT01246206 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Barbara Ann Karmanos Cancer Institute, which has 139 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Tacrolimus and Thymoglobulin is the first listed.

NCT01246206 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01246206 about?

NCT01246206 is a clinical study titled "Tacrolimus and Thymoglobulin, as GvHD Prophylaxis in Patients Undergoing Related Donor HCT". The primary goal of the study is to determine the incidence and severity of acute Graft versus Host Disease (GVHD) following human leukocyte antigen (HLA) matched related donor Hematopoetic Stem Cell(HSC) transplant in patients with blood related cancers who receive the combination of tacrolimus and...

What is the current status of trial NCT01246206?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2010-11. Estimated completion is 2013-10.

What interventions are being tested in trial NCT01246206?

The interventions under investigation include: Tacrolimus and Thymoglobulin (DRUG).

Who is sponsoring clinical trial NCT01246206?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.