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NCT00049504 · ClinicalTrials.gov registry record · Phase 2

Haploidentical Donor Bone Marrow Transplant in Treating Patients With High-Risk Hematologic Cancer

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

Completed
Registry status
Phase 2
Development phase
53
Enrollment target

NCT00049504: Completed Phase 2 study, sponsored by Fred Hutchinson Cancer Center.

NCT00049504 is a Phase 2 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00049504, a Phase 2 study, has completed, sponsored by Fred Hutchinson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
53 participants
Enrollment target

Study Summary

This phase II trial studies how well giving fludarabine phosphate, cyclophosphamide, tacrolimus, mycophenolate mofetil and total-body irradiation together with a donor bone marrow transplant works in treating patients with high-risk hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate and cyclophosphamide, and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells by stopping them from dividing or killing them. Giving cyclophosphamide after transplant may also stop the patient's immune system from rejecting the donor's bone marrow stem cells. The donated stem cells may replace the patient's immune system cells and help destroy any remaining 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 tacrolimus and mycophenolate mofetil after the transplant may stop this from happening

Primary Outcome

Defined by the detection of at least 50% donor derived T-cells (CD3+), as a proportion of the total T-cell population

Interventions

  • DRUG cyclophosphamide
  • GENETIC polymerase chain reaction
  • DRUG fludarabine phosphate
  • DRUG tacrolimus
  • DRUG mycophenolate mofetil

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2002-01
Est. Completion 2014-02
Phase Phase 2
Fred Hutchinson Cancer Center

483 total trials

What the finished NCT00049504 record still lists

NCT00049504 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).

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

NCT00049504 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00049504 about?

NCT00049504 is a clinical study titled "Haploidentical Donor Bone Marrow Transplant in Treating Patients With High-Risk Hematologic Cancer". This phase II trial studies how well giving fludarabine phosphate, cyclophosphamide, tacrolimus, mycophenolate mofetil and total-body irradiation together with a donor bone marrow transplant works in treating patients with high-risk hematologic cancer. Giving low doses of chemotherapy, such as fluda...

What is the current status of trial NCT00049504?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2002-01. Estimated completion is 2014-02.

What interventions are being tested in trial NCT00049504?

The interventions under investigation include: cyclophosphamide (DRUG), polymerase chain reaction (GENETIC), fludarabine phosphate (DRUG), tacrolimus (DRUG), mycophenolate mofetil (DRUG).

Who is sponsoring clinical trial NCT00049504?

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 NCT00049504's enrollment target sits among peer trials

53 1171st of 2000 higher than 820 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 NCT00049504, the US trial registry maintained by the National Library of Medicine. NCT00049504 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.