Phase II Trial of Alisertib With Induction Chemotherapy in High-risk AML

NCT02560025 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2020-05-05

Study results available
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Summary

This research study is studying a targeted therapy (a form of treatment that uses drugs or other substances to identify and attack specific types of cancer cells with less harm to normal cells) as a possible treatment for high-risk acute myeloid leukemia.

The names of the study interventions involved in this study are:

* Alisertib / MLN8237
* Cytarabine / Cytosine Arabinoside
* Idarubicin / Idarubicin hydrochloride
* Daunorubicin (Can be used in place of idarubicin)

Conditions

Interventions

DRUG

Alisertib

DRUG

Cytarabine

DRUG

Idarubicin

DRUG

Daunorubicin

Can be used in place of idarubicin

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY
  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Amir Fathi, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-10-31
Completion
2018-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02560025 on ClinicalTrials.gov