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NCT00003056 · ClinicalTrials.gov registry record · Phase 3

Prevention of Graft-Versus-Host Disease in Patients With Advanced Leukemia or Lymphoma Who Are Eligible for Peripheral Stem Cell Transplantation

A Phase 3 study, sponsored by Baxalta now part of Shire.

Terminated
Registry status
Phase 3
Development phase
105
Enrollment target

NCT00003056: Clinical Trial Phase 3 study, sponsored by Baxalta now part of Shire.

NCT00003056 is a Phase 3 study that was terminated before completion, run by Baxalta now part of Shire. The registered enrollment target is 105 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00003056, a Phase 3 study, was terminated before completion, sponsored by Baxalta now part of Shire.

TERMINATED
Registry status
Phase 3
Development phase
105 participants
Enrollment target

Study Summary

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. PURPOSE: Randomized phase III trial to compare the effectiveness of cyclosporine plus methotrexate with cyclosporine plus T cell depletion for prevention of graft-versus-host disease during peripheral stem cell transplantation in patients who have advanced leukemia or lymphoma who are eligible for transplanted peripheral stem cells from a donor.

Interventions

  • DRUG cyclosporine
  • DRUG cyclosporine and methotrexate

Trial Details

FieldValue
Enrollment Target 105 participants
Start Date 1997-04-01
Est. Completion 2003-06-01
Phase Phase 3
Baxalta now part of Shire

74 total trials

Why NCT00003056 stopped before completion

NCT00003056 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).

The record links to 0 conditions, and to 2 interventions - of which cyclosporine is the first listed.

NCT00003056 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00003056 about?

NCT00003056 is a clinical study titled "Prevention of Graft-Versus-Host Disease in Patients With Advanced Leukemia or Lymphoma Who Are Eligible for Peripheral Stem Cell Transplantation". RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. PURPOSE: Randomized phase III trial ...

What is the current status of trial NCT00003056?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 105 participants. The study started on 1997-04-01. Estimated completion is 2003-06-01.

What interventions are being tested in trial NCT00003056?

The interventions under investigation include: cyclosporine (DRUG), cyclosporine and methotrexate (DRUG).

Who is sponsoring clinical trial NCT00003056?

This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00003056's enrollment target sits among peer trials

105 1670th of 2000 higher than 330 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00003056, the US trial registry maintained by the National Library of Medicine. NCT00003056 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.