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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) (ALCANZA)

Primary Purpose

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

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Brentuximab Vedotin

Methotrexate

Bexarotene

About this trial

This is an interventional treatment trial for Primary Cutaneous Anaplastic Large Cell Lymphoma focused on measuring Brentuximab vedotin, ALCANZA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Brentuximab vedotin

Methotrexate or Bexarotene

Arm Description

Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).

Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4)

ORR4 was determined by an Independent Review Facility (IRF) based on Global Response Score (GRS) which consisted of a skin assessment by the investigator using the modified severity-weighted assessment tool (mSWAT), nodal and visceral radiographic assessment by an IRF and for the participants with mycosis fungoides (MF) only, detection of circulation Sezary cells. Participants whose first response occurred after the start of subsequent anticancer therapy were excluded. Response Criteria was based on International Society for Cutaneous Lymphomas (ISCL), United States Cutaneous Lymphoma Consortium (USCLC) and Cutaneous Lymphoma Task Force (CLTF) of the European Organisation for Research and Treatment of Cancer (EORTC) Consensus guidelines (Olsen, 2011).

Secondary Outcome Measures

Percentage of Participants Achieving a CR

Complete Response (CR) was determined by the IRF based on Global Response Score (GRS) which consisted of a skin assessment by the investigator using the modified severity-weighted assessment tool (mSWAT), nodal and visceral radiographic and for the participants with mycosis fungoides (MF) only, detection of circulation Sezary cells. Response Criteria was based on ISCL, USCLC and CLTF of the EORTC Consensus guidelines (Olsen, 2011).

Progression-Free Survival (PFS)

PFS was assessed by the IRF and is defined as the time from randomization until disease progression or death due to any cause, whichever occurs first. Disease progression was based on ISCL, USCLC and CLTF of the EORTC Consensus guidelines (Olsen, 2011).

Maximum Change From Baseline in Symptom Domain Score of the Skindex-29 Questionnaire

Skindex-29 is a 29-item dermatology-specific health-related quality of life (HRQoL). The Skindex-29 incorporates a 28-day recall period and consists of 3 domains: symptoms, emotions, and functioning. The domain scores and an overall score are expressed on a 100-point scale, from 0 to 100 with higher scores indicating lower levels of health- HRQoL. A negative change (reduction) from Baseline indicates improvement.

Duration of Response (DOR)

Duration of response was assessed by the IRF in participants with confirmed response [CR or Partial Response (PR)] and is defined as the time between first documentation of response and disease progression. Response Criteria was based on ISCL, USCLC and CLTF of the EORTC Consensus guidelines (Olsen, 2011).

DOR of Skin Response

Duration of skin response (CR and PR) was assessed by the investigator and is defined as the time between the first skin response to progressive disease in skin. Per mSWAT, CR is defined as 100% clearance of skin lesions. PR is defined as 50%-99% clearance of skin disease from Baseline; No new tumors in participants without tumors at Baseline -MF; No new tumors-primary cutaneous anaplastic large cell lymphoma (pcALCL).Progressive disease is defined as ≥ 25% increase in skin disease from baseline, or loss of response: in those with CR or PR, increase of skin score of greater than the sum of nadir plus 50% baseline score, or new tumors in participants without tumors at baseline (MF).

Event-Free Survival (EFS)

EFS was assessed by the IRF and is defined as the time from randomization until any cause of treatment failure: disease progression, discontinuation of treatment for any reason, or death due to any cause, whichever occurs first. Disease progression was based on ISCL, USCLC and CLTF of the EORTC Consensus guidelines (Olsen, 2011).

Cmax: Maximum Observed Concentration for Brentuximab Vedotin

Ctrough: Observed Concentration at the End of a Dosing Interval for Brentuximab Vedotin

Cmax: Maximum Observed Concentration for Monomethyl Auristatin (MMAE) for Brentuximab Vedotin

Ctrough: Observed Concentration at the End of a Dosing Interval for MMAE for Brentuximab Vedotin

Number of Participants With Antitherapeutic Antibodies (ATA) to Brentuximab Vedotin

Blood was collected and evaluated for ATA and neutralizing ATA in all participants who received brentuximab vedotin to assess immunogenicity.

Change From Baseline in the Skindex-29 Questionnaire Total Score

Skindex-29 is a 29-item dermatology-specific health-related quality of life (HRQoL). The Skindex-29 incorporates a 28-day recall period and consists of 3 domains: symptoms, emotions, and functioning. The domain scores and an overall score are expressed on a 100-point scale, 0 to 100 with higher scores indicating lower levels of health- HRQoL. A negative change (reduction) from Baseline indicates improvement.

Change From Baseline in Functional Assessment of Cancer Therapy General Questionnaire (FACT-G) Score

FACT-G is a 27-item general cancer QOL instrument completed by participants receiving cancer treatment. FACT-G incorporates a 7-day recall period and contains 4 primary subscales: Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28); Fact-G total score=sum of PWB, SWB, EWB, FWB, point range 0-108. Higher scores for the total scales and subscales indicate better quality of life. A negative change (reduction) from Baseline indicates improvement.

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

AEs and SAEs were assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.

Full Information

NCT ID

NCT01578499

First Posted

March 27, 2012

Last Updated

December 16, 2020

Sponsor

Millennium Pharmaceuticals, Inc.

Collaborators

Seagen Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01578499

Brief Title

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)

Acronym

ALCANZA

Official Title

A Randomized, Open-Label, Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

June 11, 2012 (Actual)

Primary Completion Date

May 31, 2016 (Actual)

Study Completion Date

July 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Millennium Pharmaceuticals, Inc.

Collaborators

Seagen Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed Description

The drug being tested in this study is called brentuximab vedotin. Brentuximab vedotin is being tested to treat people who have CD30+ cutaneous T-cell lymphoma (mycosis fungoides and primary cutaneous anaplastic large cell lymphoma). This study will look at the overall response of people who took brentuximab vedotin compared to people who took methotrexate or bexarotene as standard care. The study enrolled 131 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): Methotrexate 5 to 50 mg or Bexarotene 300 mg/m^2 (as per physician's choice) Brentuximab vedotin 1.8 mg/kg This multicenter trial is being conducted worldwide. The overall time to participate in this study is approximately 6 years. Participants will make multiple visits to the clinic every 12 weeks for a minimum of 24 months after the end of treatment (EOT) visit, and then every 6 months until death, study closure, or 6 years after enrollment of the last participant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Brentuximab vedotin, ALCANZA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

131 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Brentuximab vedotin

Arm Type

Experimental

Arm Description

Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).

Arm Title

Methotrexate or Bexarotene

Arm Type

Active Comparator

Arm Description

Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.

Intervention Type

Drug

Intervention Name(s)

Brentuximab Vedotin

Other Intervention Name(s)

SGN-35

Intervention Description

Brentuximab vedotin intravenous injection.

Intervention Type

Drug

Intervention Name(s)

Methotrexate

Intervention Description

Methotrexate tablets.

Intervention Type

Drug

Intervention Name(s)

Bexarotene

Intervention Description

Bexarotene tablets.

Primary Outcome Measure Information:

Title

Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4)

Description

Time Frame

Each Cycle until disease progression, death End of treatment (Median overall follow-up 38.8 months)

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving a CR

Description

Time Frame

Each Cycle until disease progression, death or data cutoff (Median overall follow-up 38.8 months)

Title

Progression-Free Survival (PFS)

Description

Time Frame

Until disease progression, death or data cutoff (Median PFS follow-up of 38.8 months)

Title

Maximum Change From Baseline in Symptom Domain Score of the Skindex-29 Questionnaire

Description

Time Frame

Baseline up to End of Treatment (Week 52)

Title

Duration of Response (DOR)

Description

Time Frame

Until disease progression, death or data cutoff (Median follow-up 38.8 months)

Title

DOR of Skin Response

Description

Time Frame

Until disease progression, death or data cutoff (Median follow-up 38.8 months)

Title

Event-Free Survival (EFS)

Description

Time Frame

From randomization until disease progression, death or data cutoff (Median follow-up 36.8 months)

Title

Cmax: Maximum Observed Concentration for Brentuximab Vedotin

Time Frame

Day 1 pre-dose and 30 minutes after infusion in Cycles 1 and 3

Title

Ctrough: Observed Concentration at the End of a Dosing Interval for Brentuximab Vedotin

Time Frame

Day 1 pre-dose of Cycles 2 and 4

Title

Cmax: Maximum Observed Concentration for Monomethyl Auristatin (MMAE) for Brentuximab Vedotin

Time Frame

Day 1 pre-dose and 30 minutes after infusion ended in Cycles 1 and 3

Title

Ctrough: Observed Concentration at the End of a Dosing Interval for MMAE for Brentuximab Vedotin

Time Frame

Day 1 pre-dose of Cycles 2 and 4

Title

Number of Participants With Antitherapeutic Antibodies (ATA) to Brentuximab Vedotin

Description

Blood was collected and evaluated for ATA and neutralizing ATA in all participants who received brentuximab vedotin to assess immunogenicity.

Time Frame

Baseline up to End of Treatment (Week 52)

Title

Change From Baseline in the Skindex-29 Questionnaire Total Score

Description

Skindex-29 is a 29-item dermatology-specific health-related quality of life (HRQoL). The Skindex-29 incorporates a 28-day recall period and consists of 3 domains: symptoms, emotions, and functioning. The domain scores and an overall score are expressed on a 100-point scale, 0 to 100 with higher scores indicating lower levels of health- HRQoL. A negative change (reduction) from Baseline indicates improvement.

Time Frame

Day 1 of Cycles 1, 2, 4, 6, 8, 10, 12, 14, 16, at End of Treatment (EOT) and during posttreatment long treatment follow-up (LTFU) - (Median follow-up 38.8 months)

Title

Change From Baseline in Functional Assessment of Cancer Therapy General Questionnaire (FACT-G) Score

Description

Time Frame

Day 1 of Cycles 1, 2, 4, 6, 8, 10, 12, 14, 16, at EOT and during posttreatment (LTFU) - (Median follow-up 38.8 months)

Title

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Description

Time Frame

First dose of study drug through 30 days after last dose of study drug (Up to 450 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Millennium Pharmaceuticals, Inc.

Official's Role

Study Director

Facility Information:

City

Los Angeles

State/Province

California

Country

United States

City

Palo Alto

State/Province

California

Country

United States

City

Chicago

State/Province

Illinois

Country

United States

City

Boston

State/Province

Massachusetts

Country

United States

City

Hackensack

State/Province

New Jersey

Country

United States

City

New York

State/Province

New York

Country

United States

City

Pittsburgh

State/Province

Pennsylvania

Country

United States

City

Houston

State/Province

Texas

Country

United States

City

Concord

State/Province

New South Wales

Country

Australia

City

South Brisbane

State/Province

Queensland

Country

Australia

City

Adelaide

State/Province

South Australia

Country

Australia

City

Nedlands

State/Province

Western Australia

Country

Australia

City

East Melbourne

Country

Australia

City

St. Poelten

Country

Austria

City

Wien

Country

Austria

City

Leuven

Country

Belgium

City

Sao Paulo

Country

Brazil

City

Nantes Cedex 01

Country

France

City

Paris

Country

France

City

Pessac Cedex

Country

France

City

Pierre Benite

Country

France

City

Reims

Country

France

City

Kiel

Country

Germany

City

Krefeld

Country

Germany

City

Mainz

Country

Germany

City

Mannheim

Country

Germany

City

Minden

Country

Germany

City

Wurzburg

Country

Germany

City

Bologna

Country

Italy

City

Firenze

Country

Italy

City

Meldola

Country

Italy

City

Warszawa

Country

Poland

City

Pamplona

State/Province

Navarra

Country

Spain

City

Barcelona

Country

Spain

City

Madrid

Country

Spain

City

Zurich

Country

Switzerland

City

Leeds

State/Province

West Yorkshire

Country

United Kingdom

City

Birmingham

Country

United Kingdom

City

Glasgow

Country

United Kingdom

City

London

Country

United Kingdom

City

Manchester

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing URL

https://vivli.org/ourmember/takeda/

Citations:

PubMed Identifier

34507350

Citation

Horwitz SM, Scarisbrick JJ, Dummer R, Whittaker S, Duvic M, Kim YH, Quaglino P, Zinzani PL, Bechter O, Eradat H, Pinter-Brown L, Akilov OE, Geskin L, Sanches JA, Ortiz-Romero PL, Weichenthal M, Fisher DC, Walewski J, Trotman J, Taylor K, Dalle S, Stadler R, Lisano J, Bunn V, Little M, Prince HM. Randomized phase 3 ALCANZA study of brentuximab vedotin vs physician's choice in cutaneous T-cell lymphoma: final data. Blood Adv. 2021 Dec 14;5(23):5098-5106. doi: 10.1182/bloodadvances.2021004710.

Results Reference

derived

PubMed Identifier

33794441

Citation

Kim YH, Prince HM, Whittaker S, Horwitz SM, Duvic M, Bechter O, Sanches JA, Stadler R, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Eradat H, Pinter-Brown LC, Ortiz-Romero PL, Akilov OE, Trotman J, Taylor K, Weichenthal M, Walewski J, Fisher D, McNeeley M, Gru AA, Brown L, Palanca-Wessels MC, Lisano J, Onsum M, Bunn V, Little M, Trepicchio WL, Dummer R. Response to brentuximab vedotin versus physician's choice by CD30 expression and large cell transformation status in patients with mycosis fungoides: An ALCANZA sub-analysis. Eur J Cancer. 2021 May;148:411-421. doi: 10.1016/j.ejca.2021.01.054. Epub 2021 Mar 29.

Results Reference

derived

PubMed Identifier

32632956

Citation

Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.

Results Reference

derived

PubMed Identifier

32502876

Citation

Dummer R, Prince HM, Whittaker S, Horwitz SM, Kim YH, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Eradat H, Pinter-Brown L, Sanches JA, Ortiz-Romero PL, Akilov OE, Geskin L, Huen A, Walewski J, Wang Y, Lisano J, Richhariya A, Feliciano J, Zhu Y, Bunn V, Little M, Zagadailov E, Dalal MR, Duvic M. Patient-reported quality of life in patients with relapsed/refractory cutaneous T-cell lymphoma: Results from the randomised phase III ALCANZA study. Eur J Cancer. 2020 Jul;133:120-130. doi: 10.1016/j.ejca.2020.04.010. Epub 2020 Jun 2.

Results Reference

derived

PubMed Identifier

28600132

Citation

Prince HM, Kim YH, Horwitz SM, Dummer R, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Sanches JA, Ortiz-Romero PL, Akilov OE, Geskin L, Trotman J, Taylor K, Dalle S, Weichenthal M, Walewski J, Fisher D, Dreno B, Stadler R, Feldman T, Kuzel TM, Wang Y, Palanca-Wessels MC, Zagadailov E, Trepicchio WL, Zhang W, Lin HM, Liu Y, Huebner D, Little M, Whittaker S, Duvic M; ALCANZA study group. Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial. Lancet. 2017 Aug 5;390(10094):555-566. doi: 10.1016/S0140-6736(17)31266-7. Epub 2017 Jun 7.

Results Reference

derived

Links:

URL

https://www.alcanzaclinicaltrial.com/

Description

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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)

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