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NCT01383447 · ClinicalTrials.gov registry record · Phase 1

Entinostat And Imatinib Mesylate In Treating Patients With Relapsed or Refractory Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Terminated
Registry status
Phase 1
Development phase
2
Enrollment target

NCT01383447: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT01383447 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01383447, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).

TERMINATED
Registry status
Phase 1
Development phase
2 participants
Enrollment target

Study Summary

This phase I/II trial is studying the side effects and best dose of entinostat when given together with imatinib mesylate and to see how well it works in treating patients with relapsed or refractory Philadelphia chromosome-positive acute lymphoblastic leukemia. Entinostat and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth

Primary Outcome

The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.

Interventions

  • OTHER laboratory biomarker analysis
  • DRUG imatinib mesylate
  • OTHER pharmacological study
  • GENETIC western blotting
  • DRUG entinostat

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2010-10
Est. Completion 2012-04
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

Why NCT01383447 stopped before completion

NCT01383447 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).

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

NCT01383447 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01383447 about?

NCT01383447 is a clinical study titled "Entinostat And Imatinib Mesylate In Treating Patients With Relapsed or Refractory Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia". This phase I/II trial is studying the side effects and best dose of entinostat when given together with imatinib mesylate and to see how well it works in treating patients with relapsed or refractory Philadelphia chromosome-positive acute lymphoblastic leukemia. Entinostat and imatinib mesylate may ...

What is the current status of trial NCT01383447?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2010-10. Estimated completion is 2012-04.

What interventions are being tested in trial NCT01383447?

The interventions under investigation include: laboratory biomarker analysis (OTHER), imatinib mesylate (DRUG), pharmacological study (OTHER), western blotting (GENETIC), entinostat (DRUG).

Who is sponsoring clinical trial NCT01383447?

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 NCT01383447's enrollment target sits among peer trials

2 2000th of 2000 the lowest 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 NCT01383447, the US trial registry maintained by the National Library of Medicine. NCT01383447 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.