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NCT02085408 · ClinicalTrials.gov registry record · Phase 3

Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

A Phase 3 study, sponsored by ECOG-ACRIN Cancer Research Group.

Completed
Registry status
Phase 3
Development phase
727
Enrollment target

NCT02085408: Completed Phase 3 study, sponsored by ECOG-ACRIN Cancer Research Group.

NCT02085408 is a Phase 3 study that has completed, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 727 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02085408, a Phase 3 study, has completed, sponsored by ECOG-ACRIN Cancer Research Group.

COMPLETED
Registry status
Phase 3
Development phase
727 participants
Enrollment target

Study Summary

This randomized phase III trial studies clofarabine to see how well it works compared with daunorubicin hydrochloride and cytarabine when followed by decitabine or observation in treating older patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as clofarabine, daunorubicin hydrochloride, cytarabine, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which chemotherapy regimen is more effective in treating acute myeloid leukemia.

Primary Outcome

Overall survival is defined as the time from randomization to death or date last known alive.

Interventions

  • OTHER Observation
  • DRUG Decitabine
  • DRUG Cytarabine
  • DRUG Daunorubicin
  • DRUG Clofarabine

Trial Details

FieldValue
Enrollment Target 727 participants
Start Date 2011-02-04
Est. Completion 2022-12-21
Phase Phase 3
ECOG-ACRIN Cancer Research Group

75 total trials

What the finished NCT02085408 record still lists

NCT02085408 is an interventional study that assigns participants to a tested intervention. The registered 727 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.

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

NCT02085408 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02085408 about?

NCT02085408 is a clinical study titled "Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia". This randomized phase III trial studies clofarabine to see how well it works compared with daunorubicin hydrochloride and cytarabine when followed by decitabine or observation in treating older patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as clofarabine, dau...

What is the current status of trial NCT02085408?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 727 participants. The study started on 2011-02-04. Estimated completion is 2022-12-21.

What interventions are being tested in trial NCT02085408?

The interventions under investigation include: Observation (OTHER), Decitabine (DRUG), Cytarabine (DRUG), Daunorubicin (DRUG), Clofarabine (DRUG).

Who is sponsoring clinical trial NCT02085408?

This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02085408's enrollment target sits among peer trials

727 490th of 2000 higher than 1,511 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 NCT02085408, the US trial registry maintained by the National Library of Medicine. NCT02085408 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.