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MLN 9708 in Induction and Consolidation for Adults With AML >= 60 Years of Age

NCT02582359 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2022-08-24

No results posted yet for this study

Summary

This research study is evaluating drugs called Millennium 9708 (referred to as MLN9708) in combination with standard therapy for acute myeloid leukemia (AML) consisting of daunorubicin and cytarabine as a possible treatment for the patient AML.

Conditions

Interventions

DRUG

MLN9708

Dose of 1.5 mg or 2.3 mg or 3.0 mg taken by mouth on days 2, 5, 9, 12 of each cycle.

DRUG

Cytarabine

Induction: cytarabine 100 mg/m2/day continuous infusion, days 1-7 Consolidation: cytarabine 2000 mg/m2/day, 3 hour infusion, on days 1-5

DRUG

Daunorubicin

Daunorubicin 60 mg/m2, IV bolus, on days 1-3 of induction, only.

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Philip C Amrein, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2022-04-30
Completion
2022-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02582359 on ClinicalTrials.gov