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Four Drug Reinduction With Bortezomib for Relapsed or Refractory ALL or LL in Children and Young Adults

NCT02535806 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-08-13

Study results available
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Summary

This is a phase II study designed to investigate the combination of bortezomib with the mitoxantrone reinduction regimen used in the ALL R3 trial. The study will enroll patients with high risk ALL relapse including early bone marrow relapse and second or greater relapse of any kind. Patients with relapsed LL will also be eligible. Bone marrow evaluation will be performed after blood counts recover to assess the rate of CR (\<5% bone marrow blasts) and MRD status in children following this regimen. Further treatment with or without HSCT will be at the discretion of the primary physician.

Conditions

Interventions

DRUG

Velcade

4 doses of study drug will be given.

DRUG

Methotrexate

Intrathecal dose For CNS negative patients, Day 1 and Day 8

DRUG

Methotrexate / Hydrocortisone / Cytarabine

Intrathecal dose for CNS positive patients, Day 1, 8, 15, 22

DRUG

Dexamethasone

Days 1-5 and 15-19

DRUG

Mitoxantrone

Days 1 and 2

DRUG

Vincristine

Days 1, 8, 15, 22

DRUG

Pegaspargase

Days 3 and 17

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Children's Mercy Hospital Kansas City

    lead OTHER

Principal Investigators

  • Keith J August, MD · Children's Mercy Hospital Kansas City

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2017-05-25
Completion
2017-05-25
FDA Drug
Yes

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 NCT02535806 on ClinicalTrials.gov