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COMPLETED Phase 1

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

NCT02236013 · View on ClinicalTrials.gov ↗

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

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

Sponsor

Astellas Pharma Global Development

172 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02236013

The ClinicalTrials.gov registry entry for NCT02236013 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 172 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02236013 reports 10 study locations spanning 10 distinct geographic areas — top geographies include California, Connecticut, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02236013?

The interventions under investigation include: Cytarabine (DRUG), Idarubicin (DRUG), Daunorubicin (DRUG), Gilteritinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02236013?

This trial is sponsored by Astellas Pharma Global Development, which has 172 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial