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NCT02635074 · ClinicalTrials.gov registry record · Phase 1
Ibrutinib, Idarubicin and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1 study, sponsored by Steven E. Coutre.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT02635074: Clinical Trial Phase 1 study, sponsored by Steven E. Coutre.
NCT02635074 is a Phase 1 study that was terminated before completion, run by Steven E. Coutre. 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.
The verdict
NCT02635074, a Phase 1 study, was terminated before completion, sponsored by Steven E. Coutre.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of ibrutinib when given together with idarubicin and cytarabine in treating patients with acute myeloid leukemia that has returned after a period of improvement or has not responded to previous treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib together with idarubicin and cytarabine may kill more cancer cells.
Primary Outcome
The induction Response Rate (CR/CRi) of ibrutinib in combination with idarubicin/cytarabine in relapsed/refractory AML was assessed as the number of participants who achieving a complete response (CR) or complete response with incomplete blood count recovery (CRi), divided by the total number of participants completing induction therapy.
Interventions
- DRUG Cytarabine
- DRUG Idarubicin
- DRUG Ibrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2016-11 |
| Est. Completion | 2017-11-10 |
| Phase | Phase 1 |
Why NCT02635074 stopped before completion
NCT02635074 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 3 interventions - of which Cytarabine is the first listed.
NCT02635074 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02635074 about?
NCT02635074 is a clinical study titled "Ibrutinib, Idarubicin and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia". This phase I trial studies the side effects and best dose of ibrutinib when given together with idarubicin and cytarabine in treating patients with acute myeloid leukemia that has returned after a period of improvement or has not responded to previous treatment. Ibrutinib may stop the growth of canc...
What is the current status of trial NCT02635074?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2016-11. Estimated completion is 2017-11-10.
What interventions are being tested in trial NCT02635074?
The interventions under investigation include: Cytarabine (DRUG), Idarubicin (DRUG), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT02635074?
This trial is sponsored by Steven E. Coutre, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02635074'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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