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NCT00028899 · ClinicalTrials.gov registry record · Phase 1

Monoclonal Antibody Plus Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes

A Phase 1 study, sponsored by Children's Oncology Group.

Completed
Registry status
Phase 1
Development phase
47
Enrollment target

NCT00028899: Completed Phase 1 study, sponsored by Children's Oncology Group.

NCT00028899 is a Phase 1 study that has completed, run by Children's Oncology Group. 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.

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The verdict

NCT00028899, a Phase 1 study, has completed, sponsored by Children's Oncology Group.

COMPLETED
Registry status
Phase 1
Development phase
47 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with combination chemotherapy may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of combining gemtuzumab ozogamicin with combination chemotherapy in treating children who have relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.

Interventions

  • DRUG cytarabine
  • DRUG gemtuzumab ozogamicin
  • DRUG asparaginase
  • DRUG mitoxantrone hydrochloride

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2002-07
Est. Completion 2012-03
Phase Phase 1
Children's Oncology Group

342 total trials

What the finished NCT00028899 record still lists

NCT00028899 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 4 interventions - of which cytarabine is the first listed.

NCT00028899 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00028899 about?

NCT00028899 is a clinical study titled "Monoclonal Antibody Plus Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes". RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Com...

What is the current status of trial NCT00028899?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2002-07. Estimated completion is 2012-03.

What interventions are being tested in trial NCT00028899?

The interventions under investigation include: cytarabine (DRUG), gemtuzumab ozogamicin (DRUG), asparaginase (DRUG), mitoxantrone hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00028899?

This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00028899'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 NCT00028899, the US trial registry maintained by the National Library of Medicine. NCT00028899 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.