Phase 3 N=131 Randomized Treatment

A Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Participants With CD30-Positive Cutaneous T-Cell Lymphoma (ALCANZA Study)

Primary Cutaneous Anaplastic Large Cell Lymphoma · Mycosis Fungoides · Cutaneous T-Cell Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT01578499 ↗

Enrolled (actual)

131

Serious AEs

28.1%

Results posted

Mar 2018

Primary outcome: Primary: Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4) — 54.7; 12.5 percentage of participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Brentuximab Vedotin (Drug); Methotrexate (Drug); Bexarotene (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Millennium Pharmaceuticals, Inc.
Primary completion: May 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4)	54.7; 12.5	<0.001 sig
SECONDARY Percentage of Participants Achieving a CR	17.2; 1.6	0.0002 sig
SECONDARY Progression-Free Survival (PFS)	16.7; 3.5	<0.001 sig
SECONDARY Maximum Change From Baseline in Symptom Domain Score of the Skindex-29 Questionnaire	-28.08; -8.62	<0.001 sig
SECONDARY Duration of Response (DOR)	15.1; 18.4	—
SECONDARY DOR of Skin Response	18.9; 18.3	—
SECONDARY Event-Free Survival (EFS)	9.4; 2.3	—
SECONDARY Cmax: Maximum Observed Concentration for Brentuximab Vedotin	38.36; 38.40; 40.14; 36.69	—
SECONDARY Ctrough: Observed Concentration at the End of a Dosing Interval for Brentuximab Vedotin	3.57; 0.58; 0.99; 0.78	—
SECONDARY Cmax: Maximum Observed Concentration for Monomethyl Auristatin (MMAE) for Brentuximab Vedotin	2.53; 3.34; 2.96; 3.08	—
SECONDARY Ctrough: Observed Concentration at the End of a Dosing Interval for MMAE for Brentuximab Vedotin	0.11; 0.09; 0.14; 0.11	—
SECONDARY Number of Participants With Antitherapeutic Antibodies (ATA) to Brentuximab Vedotin	14; 46; 8; 23; 6; 19	—
SECONDARY Change From Baseline in the Skindex-29 Questionnaire Total Score	-5.44; -2.49; -14.60; -6.71; -17.59; -5.40	—
SECONDARY Change From Baseline in Functional Assessment of Cancer Therapy General Questionnaire (FACT-G) Score	1.43; -0.37; 1.75; 1.78; 4.23; 2.24	—
SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	63; 56; 18; 18	—

Summary

The purpose of this study is to determine objective response rate (ORR), lasting at least 4 months (ORR4), with brentuximab vedotin in participants with cluster of differentiation antigen 30 positive (CD30+) cutaneous T-cell lymphoma [mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) ]compared to that achieved with therapy in the control arm.

Eligibility Criteria

Inclusion Criteria

Voluntary consent form
Male or female participants 18 years or older with diagnosis of mycosis fungoides (MF) or primary cutaneous anaplastic large cell lymphoma (pcALCL)
Participants with pcALCL who have received prior radiation therapy or at least 1 prior systemic therapy; participants with MF who have received at least 1 prior systemic therapy
Histologically confirmed CD30+ disease by central laboratory assessment and pathology review
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Female participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant
Male participants who agree to practice effective barrier contraception or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant
Clinical laboratory values as specified in protocol
A 3-week washout period is required from previous treatments (with the exception of a 12-week washout for antibody-directed or immunoglobulin-based immune therapy, or other monoclonal antibody therapies), unless it is not in the best interest of the patient in the opinion of the investigator. Individual cases should be discussed with the project clinician before enrollment.

Exclusion Criteria

A concurrent diagnosis of systemic ALCL, or other non Hodgkin lymphoma (excluding LyP) or Sezary syndrome or B2 disease
Participants with cardiovascular conditions specified in protocols
Participants with history of another primary malignancy not in remission for at least 3 years
Known active cerebral/meningeal disease, including signs or symptoms of progressive multifocal leukoencephalopathy (PML);
Known human immunodeficiency virus (HIV) infection, hepatitis B or Hepatitis C infection
Oral retinoid therapy for any indication within 3 weeks of study entry
Corticosteroid therapy within 3 weeks or immunosuppressive chemotherapy or any antibody-directed or immunoglobulin-based immune therapy (e.g., immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks of first dose of study drug
Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 of any cycle
Previous receipt of brentuximab vedotin Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01578499). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.