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NCT00136084 · ClinicalTrials.gov registry record · Phase 3

Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia

A Phase 3 study, sponsored by St. Jude Children's Research Hospital.

Completed
Registry status
Phase 3
Development phase
238
Enrollment target

NCT00136084: Completed Phase 3 study, sponsored by St. Jude Children's Research Hospital.

NCT00136084 is a Phase 3 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 238 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00136084, a Phase 3 study, has completed, sponsored by St. Jude Children's Research Hospital.

COMPLETED
Registry status
Phase 3
Development phase
238 participants
Enrollment target

Study Summary

The purpose of this study is to compare the effectiveness of two multi-agent chemotherapy regimens using different dosages of cytarabine to eliminate all detectable leukemia.

Primary Outcome

Detection of Minimal Residual Disease following one course of chemotherapy where positive MRD was defined as one or more leukemic cell per 1000 mononuclear bone-marrow cells (\>=0.1%).

Interventions

  • DRUG Cladribine, Cyclophosphamide, Cytarabine, Daunorubicin, Dexamethasone
  • DRUG Etoposide, Cytarabine, Gemtuzumab, L-asparaginase, Mercaptopurine, methotrexate, Mitoxantrone, Prednisone, Vincristine

Trial Details

FieldValue
Enrollment Target 238 participants
Start Date 2002-08
Est. Completion 2012-06
Phase Phase 3

What the finished NCT00136084 record still lists

NCT00136084 is an interventional study that assigns participants to a tested intervention. The registered 238 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).

The record links to 0 conditions, and to 2 interventions - of which Cladribine, Cyclophosphamide, Cytarabine, Daunorubicin, Dexamethasone is the first listed.

NCT00136084 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00136084 about?

NCT00136084 is a clinical study titled "Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia". The purpose of this study is to compare the effectiveness of two multi-agent chemotherapy regimens using different dosages of cytarabine to eliminate all detectable leukemia.

What is the current status of trial NCT00136084?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 238 participants. The study started on 2002-08. Estimated completion is 2012-06.

What interventions are being tested in trial NCT00136084?

The interventions under investigation include: Cladribine, Cyclophosphamide, Cytarabine, Daunorubicin, Dexamethasone (DRUG), Etoposide, Cytarabine, Gemtuzumab, L-asparaginase, Mercaptopurine, methotrexate, Mitoxantrone, Prednisone, Vincristine (DRUG).

Who is sponsoring clinical trial NCT00136084?

This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00136084's enrollment target sits among peer trials

238 1291st of 2000 higher than 708 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00136084, the US trial registry maintained by the National Library of Medicine. NCT00136084 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.