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NCT00303719 · ClinicalTrials.gov registry record · Phase 2

Allogeneic Bone Marrow Transplantation Using Less Intensive Therapy

A Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.

Terminated
Registry status
Phase 2
Development phase
342
Enrollment target

NCT00303719: Clinical Trial Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.

NCT00303719 is a Phase 2 study that was terminated before completion, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 342 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (157% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00303719, a Phase 2 study, was terminated before completion, sponsored by Masonic Cancer Center, University of Minnesota.

TERMINATED
Registry status
Phase 2
Development phase
342 participants
Enrollment target

Study Summary

RATIONALE: A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy, or that have become cancer. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclophosphamide and fludarabine together with total-body irradiation followed by cyclosporine and mycophenolate mofetil before the transplant may stop this from happening. PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with radiation therapy followed by cyclosporine and mycophenolate mofetil works in treating patients who are undergoing a donor stem cell transplant for hematologic cancer, metastatic breast cancer, or kidney cancer.

Primary Outcome

Successful sustained engraftment is defined as primary neutrophil engraftment by day 42 and e90% donor cells at day 100, with or without DLI. Engraftment based on absolute neutrophil count of donor origin \> 0.5 x 10e9 /L for 3 days by day 42

Interventions

  • DRUG fludarabine
  • DRUG cyclophosphamide
  • DRUG cyclosporine
  • BIOLOGICAL anti-thymocyte globulin
  • DRUG mycophenolate mofetil

Trial Details

FieldValue
Enrollment Target 342 participants
Start Date 2002-03-26
Est. Completion 2019-05-08
Phase Phase 2

Why NCT00303719 stopped before completion

NCT00303719 is an interventional study that assigns participants to a tested intervention. The registered 342 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (157% higher).

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

NCT00303719 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00303719 about?

NCT00303719 is a clinical study titled "Allogeneic Bone Marrow Transplantation Using Less Intensive Therapy". RATIONALE: A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy, or that have become cancer. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclophosph...

What is the current status of trial NCT00303719?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 342 participants. The study started on 2002-03-26. Estimated completion is 2019-05-08.

What interventions are being tested in trial NCT00303719?

The interventions under investigation include: fludarabine (DRUG), cyclophosphamide (DRUG), cyclosporine (DRUG), anti-thymocyte globulin (BIOLOGICAL), mycophenolate mofetil (DRUG).

Who is sponsoring clinical trial NCT00303719?

This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00303719's enrollment target sits among peer trials

342 136th of 2000 higher than 1,864 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 NCT00303719, the US trial registry maintained by the National Library of Medicine. NCT00303719 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.