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Phase I Study of MLN 9708 in Addition to Chemotherapy for the Treatment of Acute Lymphoblastic Leukemia in Older Adults

NCT02228772 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2019-11-26

No results posted yet for this study

Summary

This research study is evaluating a combination of drugs considered standard treatment for children and young adults with acute lymphoblastic leukemia (ALL), in combination with a new drug called MLN 9708. Additionally, the study is also evaluating if bone marrow or stem cell transplantation, which will be given to some participants, helps to prevent ALL from returning.

Conditions

Interventions

DRUG

MLN 9708

Patients will received standard chemotherapy as well as MLN 9708 in escalating doses.

DRUG

Vincristine

Standard chemotherapy dosage and duration

DRUG

Cytarabine

Standard chemotherapy dosage and duration

DRUG

Doxorubicin

Standard chemotherapy dosage and duration

DRUG

Mercaptopurine

Standard chemotherapy dosage and duration

DRUG

Cyclophosphamide

Standard chemotherapy dosage and duration

DRUG

Methotrexate

Standard chemotherapy dosage and duration

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Philip Amrein, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
51 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-10-31
Completion
2019-11-30

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 NCT02228772 on ClinicalTrials.gov