MedTrace Logo

Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma

NCT01979536 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2024-04-30

Study results available
· View outcomes & findings →

Summary

This partially randomized phase II trial studies how well brentuximab vedotin or crizotinib and combination chemotherapy works in treating patients with newly diagnosed stage II-IV anaplastic large cell lymphoma. Brentuximab vedotin is a monoclonal antibody, called brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in targeted way and delivers vedotin to kill them. Crizotinib and methotrexate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether brentuximab vedotin and combination chemotherapy is more effective than crizotinib and combination chemotherapy in treating anaplastic large cell lymphoma.

Conditions

  • Anaplastic Large Cell Lymphoma, ALK-Positive
  • Ann Arbor Stage II Noncutaneous Childhood Anaplastic Large Cell Lymphoma
  • Ann Arbor Stage III Noncutaneous Childhood Anaplastic Large Cell Lymphoma
  • Ann Arbor Stage IV Noncutaneous Childhood Anaplastic Large Cell Lymphoma

Interventions

DRUG

Brentuximab Vedotin

Given IV

DRUG

Crizotinib

Given PO

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IT and IV

DRUG

Dexamethasone

Given PO or IV

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Etoposide

Given IV

DRUG

Ifosfamide

Given IV

DRUG

Methotrexate

Given IT and IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Eric J Lowe · Children's Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-13
Primary Completion
2021-03-31
Completion
2024-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01979536 on ClinicalTrials.gov