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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ClinicalTrials.gov Identifier: NCT01578499

Recruitment Status : Active, not recruiting

First Posted : April 17, 2012

Results First Posted : March 16, 2018

Last Update Posted : March 16, 2018

Sponsor:

Collaborator:

Seattle Genetics, Inc.

Information provided by (Responsible Party):

Takeda ( Millennium Pharmaceuticals, Inc. )

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions:	Primary Cutaneous Anaplastic Large Cell Lymphoma Mycosis Fungoides Cutaneous T-Cell Lymphoma
Interventions:	Drug: Brentuximab Vedotin Drug: Methotrexate Drug: Bexarotene

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants took part in the study at 34 investigative sites in Australia, Belgium, Brazil, France, Germany, Italy, Poland, Spain, Switzerland, United Kingdom, United States from 11 June 2012 to the Primary Completion data of 31 May 2016. The study is ongoing.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with a diagnosis of cluster of differentiation antigen 30 (CD30)-Positive Cutaneous T-Cell Lymphoma were enrolled equally in 1 of 2 arms: brentuximab vedotin 1.8 mg/kg or physician’s choice (Methotrexate or Bexarotene).

Reporting Groups

	Description
Brentuximab Vedotin	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 or Bexarotene	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.

Participant Flow: Overall Study

	Brentuximab Vedotin	Methotrexate or Bexarotene
STARTED	66	65
Safety Population: Treated	66	62
Intent to Treat Population: CD30+	64	64
COMPLETED	0	0
NOT COMPLETED	66	65
Death	11	14
Withdrawal by Participant	8	10
Lost to Follow-up	2	1
Reason not Specified	0	1
Participants in Follow-up	42	39
Participants on Study Treatment	3	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population included participants who received at least 1 dose of study drug, analyzed according to the actual treatment received (n=66,62). Intent-to-treat population (ITT) population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment (n=64,64).

Reporting Groups

	Description
Brentuximab Vedotin	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 or Bexarotene	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.
Total	Total of all reporting groups

Baseline Measures

Brentuximab Vedotin

Methotrexate or Bexarotene

Total

Overall Participants Analyzed
[Units: Participants]

130

Age ^[1]
[Units: Years]
Mean (Standard Deviation)

Participants Analyzed
[Units: Participants]

128

59.4 (13.80)

56.6 (14.43)

58.0 (14.12)

^[1]	Safety population included participants who received at least 1 dose of study drug, analyzed according to the actual treatment received.

Sex: Female, Male ^[1]
[Units: Participants]
Count of Participants

Participants Analyzed
[Units: Participants]

128

Female

33 50.0%

28 45.2%

61 47.7%

Male

33 50.0%

34 54.8%

67 52.3%

^[1]	Safety population included participants who received at least 1 dose of study drug, analyzed according to the actual treatment received.

Race/Ethnicity, Customized ^[1]
[Units: Participants]

White

Participants Analyzed
[Units: Participants]

128

White

109

Black or African American

Participants Analyzed
[Units: Participants]

128

Black or African American

Asian

Participants Analyzed
[Units: Participants]

128

Asian

Not reported

Participants Analyzed
[Units: Participants]

128

Not reported

Other

Participants Analyzed
[Units: Participants]

128

Other

^[1]	ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.

Race/Ethnicity, Customized ^[1]
[Units: Participants]

Hispanic or Latino

Participants Analyzed
[Units: Participants]

128

Hispanic or Latino

Not Hispanic or Latino

Participants Analyzed
[Units: Participants]

128

Not Hispanic or Latino

110

Not reported

Participants Analyzed
[Units: Participants]

128

Not reported

^[1]	ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.

Region of Enrollment ^[1]
[Units: Participants]
Count of Participants

Australia

Participants Analyzed
[Units: Participants]

128

Australia

Belgium

Participants Analyzed
[Units: Participants]

128

Belgium

France

Participants Analyzed
[Units: Participants]

128

France

Germany

Participants Analyzed
[Units: Participants]

128

Germany

Italy

Participants Analyzed
[Units: Participants]

128

Italy

Poland

Participants Analyzed
[Units: Participants]

128

Poland

Spain

Participants Analyzed
[Units: Participants]

128

Spain

Switzerland

Participants Analyzed
[Units: Participants]

128

Switzerland

United Kingdom

Participants Analyzed
[Units: Participants]

128

United Kingdom

United States

Participants Analyzed
[Units: Participants]

128

United States

Brazil

Participants Analyzed
[Units: Participants]

128

Brazil

^[1]	Safety population included participants who received at least 1 dose of study drug, analyzed according to the actual treatment received.

Outcome Measures

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1. Primary:

Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4) [ Time Frame: Each Cycle until disease progression, death or data cutoff (Median overall follow-up 22.9 months) ]

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2. Secondary:

Percentage of Participants Achieving a CR [ Time Frame: Each Cycle until disease progression, death or data cutoff (Median overall follow-up 22.9 months) ]

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3. Secondary:

Progression-Free Survival (PFS) [ Time Frame: Until disease progression, death or data cutoff (Median PFS follow-up of 17.5 months) ]

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4. Secondary:

Maximum Change From Baseline in Symptom Domain Score of the Skindex-29 Questionnaire [ Time Frame: Baseline up to End of Treatment (Week 52) ]

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5. Secondary:

Duration of Response (DOR) [ Time Frame: Until disease progression, death or data cutoff (Median follow-up 22.9 months) ]

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6. Secondary:

DOR of Skin Response [ Time Frame: Until disease progression, death or data cutoff (Median follow-up 22.9 months) ]

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7. Secondary:

Event-Free Survival (EFS) [ Time Frame: From randomization until disease progression, death or data cutoff (Median follow-up 26.1 months) ]

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8. Secondary:

Cmax: Maximum Observed Concentration for Brentuximab Vedotin [ Time Frame: Day 1 pre-dose and 30 minutes after infusion in Cycles 1 and 3 ]

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9. Secondary:

Ctrough: Observed Concentration at the End of a Dosing Interval for Brentuximab Vedotin [ Time Frame: Day 1 pre-dose of Cycles 2 and 4 ]

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10. Secondary:

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 ]

Show Outcome Measure 10

11. Secondary:

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 ]

Show Outcome Measure 11

12. Secondary:

Number of Participants With Antitherapeutic Antibodies (ATA) to Brentuximab Vedotin [ Time Frame: Baseline up to End of Treatment (Week 52) ]

Show Outcome Measure 12

13. Secondary:

Change From Baseline in the Skindex-29 Questionnaire Total Score [ 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 22.9 months) ]

Show Outcome Measure 13

14. Secondary:

Change From Baseline in Functional Assessment of Cancer Therapy General Questionnaire (FACT-G) Score [ Time Frame: Day 1 of Cycles 1, 2, 4, 6, 8, 10, 12, 14, 16, at EOT and during posttreatment (LTFU) - (Median follow-up 22.9 months) ]

Show Outcome Measure 14

15. Secondary:

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: First dose of study drug through 30 days after last dose of study drug (Up to 395 days) ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor’s confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.

Results Point of Contact:

Name/Title: Medical Director
Organization: Takeda
phone: +1-844-662-8532
e-mail: globaloncologymedinfo@takeda.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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, Dréno 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.

Responsible Party:	Takeda ( Millennium Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier:	NCT01578499 History of Changes
Other Study ID Numbers:	C25001 2010-024215-14 ( EudraCT Number )
First Submitted:	March 27, 2012
First Posted:	April 17, 2012
Results First Submitted:	December 9, 2017
Results First Posted:	March 16, 2018
Last Update Posted:	March 16, 2018

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