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NCT00109993 · ClinicalTrials.gov registry record · Phase 2

Campath-1H + FK506 and Methylprednisolone for GVHD

A Phase 2 study of Breast Cancer and Lymphoma, sponsored by Case Comprehensive Cancer Center.

Completed
Registry status
Phase 2
Development phase
34
Enrollment target
6
Study locations

NCT00109993 is a Phase 2 study of Breast Cancer and Lymphoma that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 34 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 6 study locations across 5 states.

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The verdict

NCT00109993, a Phase 2 study of Breast Cancer and Lymphoma, has completed, sponsored by Case Comprehensive Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
34 participants
Enrollment target
6
Study locations

Study Summary

RATIONALE: Alemtuzumab, tacrolimus, and methylprednisolone may be an effective treatment for graft-versus-host disease caused by a donor stem cell transplant. PURPOSE: This phase II trial is studying how well giving alemtuzumab together with tacrolimus and methylprednisolone works in treating acute graft-versus-host disease in patients who have undergone donor stem cell transplant.

Interventions

  • DRUG methylprednisolone
  • DRUG tacrolimus
  • BIOLOGICAL alemtuzumab

Study Locations (6)

Ohio

  • Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center - Cleveland
  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center - Cleveland

New York

  • Mt. Sinai Medical Center - New York

Oregon

  • Oregon Health Sciences University - Portland

Pennsylvania

  • Western Pennsylvania Hospital - Pittsburgh

Texas

  • Texas Transplant Institute - San Antonio

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2005-01
Est. Completion 2007-05
Phase Phase 2

Sponsor

Case Comprehensive Cancer Center

407 total trials

What the Registry Record Tells You About NCT00109993

The ClinicalTrials.gov registry entry for NCT00109993 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The listed sponsor is Case Comprehensive Cancer Center, which has 407 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which methylprednisolone is the first listed.

NCT00109993 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Ohio, New York, Oregon.

Frequently Asked Questions

What is clinical trial NCT00109993 about?

NCT00109993 is a clinical study titled "Campath-1H + FK506 and Methylprednisolone for GVHD". RATIONALE: Alemtuzumab, tacrolimus, and methylprednisolone may be an effective treatment for graft-versus-host disease caused by a donor stem cell transplant. PURPOSE: This phase II trial is studying how well giving alemtuzumab together with tacrolimus and methylprednisolone works in treating acute...

What is the current status of trial NCT00109993?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2005-01. Estimated completion is 2007-05.

What conditions does trial NCT00109993 study?

This clinical trial studies the following conditions: Breast Cancer, Lymphoma, Leukemia, Myelodysplastic Syndromes, Neuroblastoma.

What interventions are being tested in trial NCT00109993?

The interventions under investigation include: methylprednisolone (DRUG), tacrolimus (DRUG), alemtuzumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT00109993?

This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00109993 being conducted?

This trial has 6 study locations across New York, Ohio, Oregon, Pennsylvania, Texas. 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

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.