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NCT00053989 · ClinicalTrials.gov registry record · Phase 2

NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/Disorders

A Phase 2 study, sponsored by Roswell Park Cancer Institute.

Completed
Registry status
Phase 2
Development phase
41
Enrollment target

NCT00053989: Completed Phase 2 study, sponsored by Roswell Park Cancer Institute.

NCT00053989 is a Phase 2 study that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 41 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00053989, a Phase 2 study, has completed, sponsored by Roswell Park Cancer Institute.

COMPLETED
Registry status
Phase 2
Development phase
41 participants
Enrollment target

Study Summary

RATIONALE: Giving low doses of chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of 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 cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving immunosuppressive therapy before or after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well chemotherapy followed by donor peripheral stem cell transplant works in treating patients with hematologic cancer or aplastic anemia.

Primary Outcome

treatment related mortality within 100 days from hematopoietic stem cell (HSC) infusion on day 0

Interventions

  • DRUG cyclophosphamide
  • BIOLOGICAL anti-thymocyte globulin
  • BIOLOGICAL sargramostim
  • BIOLOGICAL therapeutic allogeneic lymphocytes
  • BIOLOGICAL graft-versus-tumor induction therapy

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2002-01-29
Est. Completion 2018-07-19
Phase Phase 2
Roswell Park Cancer Institute

365 total trials

What the finished NCT00053989 record still lists

NCT00053989 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower).

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

NCT00053989 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00053989 about?

NCT00053989 is a clinical study titled "NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/Disorders". RATIONALE: Giving low doses of chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of 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...

What is the current status of trial NCT00053989?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2002-01-29. Estimated completion is 2018-07-19.

What interventions are being tested in trial NCT00053989?

The interventions under investigation include: cyclophosphamide (DRUG), anti-thymocyte globulin (BIOLOGICAL), sargramostim (BIOLOGICAL), therapeutic allogeneic lymphocytes (BIOLOGICAL), graft-versus-tumor induction therapy (BIOLOGICAL).

Who is sponsoring clinical trial NCT00053989?

This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00053989's enrollment target sits among peer trials

41 1352nd of 2000 higher than 639 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 NCT00053989, the US trial registry maintained by the National Library of Medicine. NCT00053989 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.