NCT01979536|CompletedPhase 2Results

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

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)ClinicalTrials.gov

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6 other identifiers

NCI-2013-02167s14-01970COG-ANHL12P1ANHL12P1U10CA098543U10CA180886

Study Type

interventional

Target

137

Locations

1 country

Sites

154

Timeline

RegisteredNov 2013

StartedNov 2013

CompletionMar 2024

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

137

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Nov 2013

Longer than P75 for phase_2

Geographic Reach

1 country

154 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10.4 years study duration

First Submitted

Initial submission to the registry

November 4, 2013

Completed

4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed

5 days until next milestone

Study Start

First participant enrolled

November 13, 2013

Completed

7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

July 6, 2022

Completed

1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed

Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

7.4 years

First QC Date

November 4, 2013

Results QC Date

June 13, 2022

Last Update Submit

April 4, 2024

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

Outcome Measures

Primary Outcomes (2)

Occurrence of Grade 3+ Non-hematologic Adverse Events
Will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Toxicities will be summarized by individual toxicity counts separated by arm.
Up to 60 months
Event Free Survival (EFS)
The Kaplan-Meier method will be used to estimate the 2-year EFS for each of the treatment regimens.
Time from study entry until progressive disease, relapse, or death, assessed up to 2 years

Secondary Outcomes (1)

Prognostic Significance of Minimal Residual Disease
Baseline up to progressive disease, relapse, or death, assessed up to 2 years

Study Arms (2)

Arm BV (brentuximab vedotin, combination chemotherapy)

EXPERIMENTAL

COURSE A (CYCLES 1, 3, AND 5): Patients receive brentuximab vedotin IV over 30 minutes on day 1, dexamethasone PO BID or IV on days 1-5, ifosfamide IV over 60 minutes on days 1-5, methotrexate IV over 3 hours on day 1, cytarabine IV over 1-30 minutes every 12 hours for 4 doses on days 4 and 5, and etoposide IV over 2 hours on days 4 and 5. COURSE B (CYCLES 2, 4, AND 6): Patients receive brentuximab vedotin, dexamethasone, and methotrexate as in Arm BV, Course A. Patients also receive cyclophosphamide IV over 15-30 minutes on days 1-5 and doxorubicin hydrochloride IV over 1-15 minutes on days 4 and 5.

Drug: Brentuximab VedotinDrug: CyclophosphamideDrug: CytarabineDrug: DexamethasoneDrug: Doxorubicin HydrochlorideDrug: EtoposideDrug: IfosfamideDrug: Methotrexate

Arm CZ (crizotinib, combination chemotherapy)

EXPERIMENTAL

COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A. COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib PO BID as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B.

Drug: CrizotinibDrug: CyclophosphamideDrug: CytarabineDrug: DexamethasoneDrug: Doxorubicin HydrochlorideDrug: EtoposideDrug: IfosfamideDrug: Methotrexate

Interventions

Brentuximab VedotinDRUG

Given IV

Also known as: ADC SGN-35, Adcetris, Anti-CD30 Antibody-Drug Conjugate SGN-35, Anti-CD30 Monoclonal Antibody-MMAE SGN-35, Anti-CD30 Monoclonal Antibody-Monomethylauristatin E SGN-35, cAC10-vcMMAE, SGN-35

Arm BV (brentuximab vedotin, combination chemotherapy)

CrizotinibDRUG

Given PO

Also known as: MET Tyrosine Kinase Inhibitor PF-02341066, PF-02341066, PF-2341066, PF02341066, Xalkori

Arm CZ (crizotinib, combination chemotherapy)

CyclophosphamideDRUG

Given IV

Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B-518, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719, WR-138719