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NCT00822770 · ClinicalTrials.gov registry record · Phase 1

Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) With Busulfan, Fludarabine and Thymoglobulin

A Phase 1 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 1
Development phase
47
Enrollment target

NCT00822770: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.

NCT00822770 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 47 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00822770, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
47 participants
Enrollment target

Study Summary

The goal of this clinical research study is to learn about the safety of AMD3100 (plerixafor) and G-CSF (filgrastim) in combination with fludarabine, busulfan, and an allogeneic blood stem cell transplant. This treatment will be studied in patients with acute myeloblastic leukemia (AML), myelodysplastic syndromes (MDS), or Chronic myelogenous leukemia (CML).

Primary Outcome

Phase I determination of MTD dose of Plerixafor in combination with a fixed dose of Filgrastim where dose limiting toxicity defined as any grade 4 non-hematologic toxicity observed within 28 days from Day 0 (day of transplant).

Interventions

  • DRUG Fludarabine
  • DRUG Busulfan
  • DRUG Plerixafor
  • DRUG Filgrastim
  • PROCEDURE Allogeneic blood stem cell transplant

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2009-01
Est. Completion 2012-10
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT00822770 record still lists

NCT00822770 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower).

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

NCT00822770 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00822770 about?

NCT00822770 is a clinical study titled "Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) With Busulfan, Fludarabine and Thymoglobulin". The goal of this clinical research study is to learn about the safety of AMD3100 (plerixafor) and G-CSF (filgrastim) in combination with fludarabine, busulfan, and an allogeneic blood stem cell transplant. This treatment will be studied in patients with acute myeloblastic leukemia (AML), myelodyspla...

What is the current status of trial NCT00822770?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2009-01. Estimated completion is 2012-10.

What interventions are being tested in trial NCT00822770?

The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG), Plerixafor (DRUG), Filgrastim (DRUG), Allogeneic blood stem cell transplant (PROCEDURE).

Who is sponsoring clinical trial NCT00822770?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00822770's enrollment target sits among peer trials

47 1053rd of 2000 higher than 943 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00822770, the US trial registry maintained by the National Library of Medicine. NCT00822770 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.