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NCT02236013 · ClinicalTrials.gov registry record · Phase 1

A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia

A Phase 1 study of Acute Myeloid Leukemia, sponsored by Astellas Pharma Global Development.

Completed
Registry status
Phase 1
Development phase
80
Enrollment target
10
Study locations

NCT02236013: Completed Phase 1 study of Acute Myeloid Leukemia, sponsored by Astellas Pharma Global Development.

NCT02236013 is a Phase 1 study of Acute Myeloid Leukemia that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 80 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (31% lower). The trial reports 10 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02236013, a Phase 1 study of Acute Myeloid Leukemia, has completed, sponsored by Astellas Pharma Global Development.

COMPLETED
Registry status
Phase 1
Development phase
80 participants
Enrollment target
10
Study locations

Study Summary

The purpose of this study is to describe the dose limiting toxicities (DLT) and define the maximum tolerated dose (MTD) of ASP2215 when combined with cytarabine/idarubicin or daunorubicin remission induction in a 7+3 schedule. Safety and tolerability of ASP2215 will also be evaluated. This study will also characterize the pharmacokinetics (PK) of ASP2215 when given in combination with cytarabine/idarubicin or cytarabine/daunorubicin remission induction and high-dose cytarabine (HiDAC) consolidation therapy in newly diagnosed acute myeloid leukemia as well as evaluate the effect of ASP2215 on the PK of cytarabine.

Conditions Studied

Acute Myeloid Leukemia

Interventions

  • DRUG Cytarabine
  • DRUG Idarubicin
  • DRUG Daunorubicin
  • DRUG Gilteritinib

Study Locations (10)

California

  • Site US10003 - Los Angeles

Connecticut

  • Site US10013 - New Haven

Illinois

  • Site US10004 - Chicago

Kansas

  • Site US10009 - Westwood

Maryland

  • Site US10001 - Baltimore

New York

  • Site US10002 - New York

Ohio

  • Site US10014 - Cleveland

Oklahoma

  • Site US10019 - Oklahoma City

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2015-01-07
Est. Completion 2021-07-26
Phase Phase 1
Astellas Pharma Global Development

168 total trials

What the finished NCT02236013 record still lists

NCT02236013 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (31% lower).

The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Cytarabine is the first listed.

NCT02236013 lists 10 locations in 10 states (California, Connecticut, Illinois).

Frequently Asked Questions

What is clinical trial NCT02236013 about?

NCT02236013 is a clinical study titled "A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia". The purpose of this study is to describe the dose limiting toxicities (DLT) and define the maximum tolerated dose (MTD) of ASP2215 when combined with cytarabine/idarubicin or daunorubicin remission induction in a 7+3 schedule. Safety and tolerability of ASP2215 will also be evaluated. This study wil...

What is the current status of trial NCT02236013?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2015-01-07. Estimated completion is 2021-07-26.

What conditions does trial NCT02236013 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia.

What interventions are being tested in trial NCT02236013?

The interventions under investigation include: Cytarabine (DRUG), Idarubicin (DRUG), Daunorubicin (DRUG), Gilteritinib (DRUG).

Who is sponsoring clinical trial NCT02236013?

This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02236013 being conducted?

This trial has 10 study locations across California, Connecticut, Illinois, Kansas, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Acute Myeloid Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02236013's enrollment target sits among peer trials

80 97th of 306 higher than 206 of 306 other Acute Myeloid Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acute Myeloid Leukemia 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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Related registry views

Source: ClinicalTrials.gov NCT02236013, the US trial registry maintained by the National Library of Medicine. NCT02236013 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.