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A Phase 3 Study to Evaluate Marqibo® in the Treatment of Subjects ≥ 60 Years Old With Newly Diagnosed ALL

NCT01439347 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-09-09

Study results available
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Summary

A phase 3 study in the treatment of subjects \>or= 60 years old with newly diagnosed acute lymphoblastic leukemia (ALL).

Conditions

  • Acute Lymphoblastic Leukemia (ALL)

Interventions

DRUG

Vincristine Sulfate Liposomes Injection (VSLI)

2.25 mg/m\^2 (without any dose cap) as an IV infusion over 60 minutes.

DRUG

Vincristine Sulfate Injection (VSI)

1.4 mg/m\^2 with a 2 mg dose cap as an IV infusion over 10 minutes.

Sponsors & Collaborators

  • Spectrum Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Susan M O'Brien, MD · MD Anderson

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States

Study Locations

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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 NCT01439347 on ClinicalTrials.gov