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NCT00003934 · ClinicalTrials.gov registry record · Phase 3

Tretinoin, Cytarabine, and Daunorubicin Hydrochloride With or Without Arsenic Trioxide Followed by Tretinoin With or Without Mercaptopurine and Methotrexate in Treating Patients With Acute Promyelocytic Leukemia

A Phase 3 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 3
Development phase
420
Enrollment target

NCT00003934: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).

NCT00003934 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 420 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00003934, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 3
Development phase
420 participants
Enrollment target

Study Summary

This randomized phase III trial is studying tretinoin and combination chemotherapy to see how well they work compared to tretinoin, combination chemotherapy, and arsenic trioxide in treating patients with acute promyelocytic leukemia that has not been treated previously. Drugs used in chemotherapy, such as daunorubicin, cytarabine, mercaptopurine, methotrexate, and arsenic trioxide, work in different ways to stop cancer cells from dividing so they stop growing or die. Tretinoin may help leukemia cells develop into normal white blood cells. It is not yet known which regimen is more effective for acute promyelocytic leukemia.

Interventions

  • DRUG mercaptopurine
  • DRUG methotrexate
  • DRUG cytarabine
  • DRUG tretinoin
  • DRUG daunorubicin hydrochloride

Trial Details

FieldValue
Enrollment Target 420 participants
Start Date 1999-06
Phase Phase 3
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00003934 record still lists

NCT00003934 is an interventional study that assigns participants to a tested intervention. The registered 420 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 (46% lower).

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

NCT00003934 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00003934 about?

NCT00003934 is a clinical study titled "Tretinoin, Cytarabine, and Daunorubicin Hydrochloride With or Without Arsenic Trioxide Followed by Tretinoin With or Without Mercaptopurine and Methotrexate in Treating Patients With Acute Promyelocytic Leukemia". This randomized phase III trial is studying tretinoin and combination chemotherapy to see how well they work compared to tretinoin, combination chemotherapy, and arsenic trioxide in treating patients with acute promyelocytic leukemia that has not been treated previously. Drugs used in chemotherapy, ...

What is the current status of trial NCT00003934?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 420 participants. The study started on 1999-06.

What interventions are being tested in trial NCT00003934?

The interventions under investigation include: mercaptopurine (DRUG), methotrexate (DRUG), cytarabine (DRUG), tretinoin (DRUG), daunorubicin hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00003934?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00003934's enrollment target sits among peer trials

420 891st of 2000 higher than 1,102 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 NCT00003934, the US trial registry maintained by the National Library of Medicine. NCT00003934 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.