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NCT00612274 · ClinicalTrials.gov registry record · Early Phase 1

Sirolimus, Tacrolimus and Short Course Methotrexate for Prevention of Acute GVHD in Recipients of Mismatched Unrelated Donor Allogeneic Stem Cell Transplantation

A Early Phase 1 study of Stem Cell Transplantation, sponsored by Yale University.

Completed
Registry status
Early Phase 1
Development phase
26
Enrollment target
1
Study location

NCT00612274 is a Early Phase 1 study of Stem Cell Transplantation that has completed, run by Yale University. The registered enrollment target is 26 participants, below the 42-participant average among 8 other Stem Cell Transplantation trials with a reported enrollment target (38% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00612274, a Early Phase 1 study of Stem Cell Transplantation, has completed, sponsored by Yale University.

COMPLETED
Registry status
Early Phase 1
Development phase
26 participants
Enrollment target
1
Study location

Study Summary

The primary objective of this trial is to study the safety and efficacy of a novel regimen of sirolimus, tacrolimus and methotrexate as prophylaxis against acute graft versus host disease (GVHD) in recipients of mismatched unrelated donor stem cell grafts. Methotrexate is administered in a low dose format of 5mg/m2 on days +1,3 and 6 only.

Conditions Studied

Interventions

  • DRUG Sirolimus
  • DRUG Methotrexate
  • DRUG tacrolimus

Study Locations (1)

Connecticut

  • Yale University School of Medicine - New Haven

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2007-10
Est. Completion 2014-10
Phase Early Phase 1

Sponsor

Yale University

1,492 total trials

What the Registry Record Tells You About NCT00612274

The ClinicalTrials.gov registry entry for NCT00612274 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 42-participant average among 8 other Stem Cell Transplantation trials with a reported enrollment target (38% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Stem Cell Transplantation appearing as the primary indexed condition, and to 3 interventions - of which Sirolimus is the first listed.

NCT00612274 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.

Frequently Asked Questions

What is clinical trial NCT00612274 about?

NCT00612274 is a clinical study titled "Sirolimus, Tacrolimus and Short Course Methotrexate for Prevention of Acute GVHD in Recipients of Mismatched Unrelated Donor Allogeneic Stem Cell Transplantation". The primary objective of this trial is to study the safety and efficacy of a novel regimen of sirolimus, tacrolimus and methotrexate as prophylaxis against acute graft versus host disease (GVHD) in recipients of mismatched unrelated donor stem cell grafts. Methotrexate is administered in a low dose ...

What is the current status of trial NCT00612274?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 26 participants. The study started on 2007-10. Estimated completion is 2014-10.

What conditions does trial NCT00612274 study?

This clinical trial studies the following conditions: Stem Cell Transplantation.

What interventions are being tested in trial NCT00612274?

The interventions under investigation include: Sirolimus (DRUG), Methotrexate (DRUG), tacrolimus (DRUG).

Who is sponsoring clinical trial NCT00612274?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00612274 being conducted?

This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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