Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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: Completed Phase 2 study, sponsored by Fred Hutchinson Cancer Center.

NCT00346359 is a Phase 2 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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
Fred Hutchinson Cancer Center

483 total trials

What the finished NCT00346359 record still lists

NCT00346359 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).

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

NCT00346359 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00346359's enrollment target sits among peer trials

40 1362nd of 2000 higher than 542 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT01306019 · 40 participants · Phase 1

    Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)

  • NCT01608152 · 40 participants

    Development of a Video Game for the Improvement of Outcomes in Stem Cell Transplant Survivors

  • NCT01668082 · 40 participants · NA

    An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection

  • NCT02015013 · 40 participants · Phase 2

    Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT00346359, the US trial registry maintained by the National Library of Medicine. NCT00346359 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.