CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 137 enrolled
Drug / intervention
Brentuximab Vedotin +8 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01979536
NCT01979536Phase 2Completed

A Randomized Phase 2 Trial of Brentuximab Vedotin (SGN35, NSC# 749710), or Crizotinib (NSC#749005, Commercially Labeled) in Combination With Chemotherapy for Newly Diagnosed Patients With Anaplastic Large Cell Lymphoma (ALCL)

National Cancer Institute (NCI)·interventional·Posted Nov 8, 2013·Updated Apr 30, 2024

In Brief

A Phase 2 clinical trial evaluating Brentuximab Vedotin, Crizotinib, and 7 other interventions for Anaplastic Large Cell Lymphoma, ALK-Positive and 3 related conditions. Completed, enrolled 137 participants across 154 sites.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 8, 2013
Enrollment StartNov 13, 2013
Primary CompletionMar 31, 2021
Study CompletionMar 31, 2024
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 12.7 years ago

Interventions

Brentuximab Vedotindrug

Given IV

Crizotinibdrug

Given PO

Cyclophosphamidedrug

Given IV

Cytarabinedrug

Given IT and IV

Dexamethasonedrug

Given PO or IV

Doxorubicin Hydrochloridedrug

Given IV

Etoposidedrug

Given IV

Ifosfamidedrug

Given IV

Methotrexatedrug

Given IT and IV