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NCT02351037 · ClinicalTrials.gov registry record · Phase 2

Study of Ibrutinib in Subjects With Acute Myeloid Leukemia

A Phase 2 study, sponsored by Pharmacyclics.

Terminated
Registry status
Phase 2
Development phase
36
Enrollment target

NCT02351037: Clinical Trial Phase 2 study, sponsored by Pharmacyclics.

NCT02351037 is a Phase 2 study that was terminated before completion, run by Pharmacyclics. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02351037, a Phase 2 study, was terminated before completion, sponsored by Pharmacyclics.

TERMINATED
Registry status
Phase 2
Development phase
36 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of ibrutinib alone or in combination with either cytarabine or azacitidine in the treatment of subjects with Acute Myeloid Leukemia (AML) who have failed standard treatment, or subjects without prior therapy who refuse standard chemotherapy.

Primary Outcome

Dohner's 2000 Criteria for AML: Complete Response (CR), Bone marrow blasts \< 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \> 1.0 x 109/L (1000/µL); platelet count \>100 x 109/L (100 000/µL); independence of red cell transfusions; CR with Incomplete Recovery (CRi), All CR criteria except for residual neutropenia (\< 1.0 x 109/L \[1000/µL\]) or thrombocytopenia (\<100 x 109/L \[100 000/µL\]) ; Morphologic leukemia-free state, Bone marrow blast

Interventions

  • DRUG Ibrutinib
  • DRUG Ibrutinib + LD-AraC
  • DRUG Ibrutinib+Azacitidine

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2015-02
Est. Completion 2017-04
Phase Phase 2
Pharmacyclics

54 total trials

Why NCT02351037 stopped before completion

NCT02351037 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 3 interventions - of which Ibrutinib is the first listed.

NCT02351037 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02351037 about?

NCT02351037 is a clinical study titled "Study of Ibrutinib in Subjects With Acute Myeloid Leukemia". The purpose of this study is to evaluate the efficacy, safety and tolerability of ibrutinib alone or in combination with either cytarabine or azacitidine in the treatment of subjects with Acute Myeloid Leukemia (AML) who have failed standard treatment, or subjects without prior therapy who refuse st...

What is the current status of trial NCT02351037?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2015-02. Estimated completion is 2017-04.

What interventions are being tested in trial NCT02351037?

The interventions under investigation include: Ibrutinib (DRUG), Ibrutinib + LD-AraC (DRUG), Ibrutinib+Azacitidine (DRUG).

Who is sponsoring clinical trial NCT02351037?

This trial is sponsored by Pharmacyclics, which has 54 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02351037's enrollment target sits among peer trials

36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT02351037, the US trial registry maintained by the National Library of Medicine. NCT02351037 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.