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NCT00346359 · ClinicalTrials.gov registry record · Phase 2

Fludarabine and Busulfan Followed by Donor Peripheral Stem Cell Transplant and Antithymocyte Globulin, Tacrolimus, and Methotrexate in Treating Patients With Myeloid Cancer

A Phase 2 study, sponsored by Fred Hutchinson Cancer Center.

Completed
Registry status
Phase 2
Development phase
40
Enrollment target

NCT00346359 is a Phase 2 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 40 participants.

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The verdict

NCT00346359, a Phase 2 study, has completed, sponsored by Fred Hutchinson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
40 participants
Enrollment target

Study Summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor peripheral stem cell transplant helps stop the growth of abnormal and cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining abnormal or cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin, tacrolimus, and methotrexate before or after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving fludarabine together with busulfan followed by donor peripheral stem cell transplant and antithymocyte globulin, tacrolimus, and methotrexate works in treating patients with myeloid cancer.

Interventions

  • DRUG fludarabine phosphate
  • DRUG tacrolimus
  • DRUG methotrexate
  • DRUG busulfan
  • BIOLOGICAL anti-thymocyte globulin

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2006-03
Est. Completion 2007-11
Phase Phase 2

Sponsor

Fred Hutchinson Cancer Center

483 total trials

What the Registry Record Tells You About NCT00346359

The ClinicalTrials.gov registry entry for NCT00346359 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.

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

NCT00346359 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00346359 about?

NCT00346359 is a clinical study titled "Fludarabine and Busulfan Followed by Donor Peripheral Stem Cell Transplant and Antithymocyte Globulin, Tacrolimus, and Methotrexate in Treating Patients With Myeloid Cancer". RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor peripheral stem cell transplant helps stop the growth of abnormal and cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the pa...

What is the current status of trial NCT00346359?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2006-03. Estimated completion is 2007-11.

What interventions are being tested in trial NCT00346359?

The interventions under investigation include: fludarabine phosphate (DRUG), tacrolimus (DRUG), methotrexate (DRUG), busulfan (DRUG), anti-thymocyte globulin (BIOLOGICAL).

Who is sponsoring clinical trial NCT00346359?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.

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

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