Study of Brentuximab Vedotin in Participants With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma

Sponsor
Takeda (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT01909934
Collaborator
Takeda Development Center Americas, Inc. (Industry)
50
Enrollment
40
Locations
1
Arm
128.1
Anticipated Duration (Months)
1.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single-arm, open-label, multicenter, phase 4 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in participants with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: brentuximab vedotin
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 4, Open-label, Single-Arm Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma
Actual Study Start Date :
Jan 30, 2014
Actual Primary Completion Date :
May 4, 2021
Anticipated Study Completion Date :
Oct 4, 2024

Arms and Interventions

ArmIntervention/Treatment
Experimental: Brentuximab vedotin

1.8 mg/kg IV infusion

Drug: brentuximab vedotin
Brentuximab vedotin will be administered as a single intravenous (IV) infusion over 30 minutes on Day 1 of each 3 week cycle for up to a maximum of 16 cycles and should be administered for a minimum of 8 cycles for participants who achieve stable disease or better.
Other Names:
  • SGN-35
  • ADCETRIS
  • Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate (ORR - Defined as Percentage of Participants with Objective Response) as Assessed by an Independent Review Facility (IRF) According to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma [Until disease progression, death or study closure (up to 5 years after the enrollment of the last participant)]

      To determine the antitumor efficacy of single-agent brentuximab vedotin as measured by ORR in participants with relapsed or refractory sALCL following at least 1 multiagent chemotherapy regimen.

    Secondary Outcome Measures

    1. Duration of Response as per IRF [Until disease progression, death or study closure (up to 5 years after the enrollment of the last participant)]

      To determine the duration of response with brentuximab vedotin.

    2. Progression-free Survival (PFS) as per IRF [Until disease progression, death or study closure (up to 5 years after the enrollment of the last participant)]

      To determine progression-free survival with brentuximab vedotin.

    3. Complete Remission Rate (CR - Defined as Percentage of Participants with CR) [Until disease progression, death or study closure (up to 5 years after the enrollment of the last participant)]

      To determine the complete remission rate with brentuximab vedotin.

    4. Overall Survival [Until death or study closure (up to 5 years after the enrollment of the last participant)]

      To determine overall survival with brentuximab vedotin.

    5. Percentage of Participants Receiving Hematopoietic Stem Cell Transplant (SCT) Following Treatment with Brentuximab Vedotin [Until disease progression, death or study closure (up to 5 years after the enrollment of the last participant)]

    6. Percentage of Participants with Adverse Events (AEs), Serious Adverse Events, Related Adverse Events and Adverse Events by Severity [Up to 30 days post last dose of study drug (up to approximately 17 months)]

      An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This includes any newly occurring event, or a previous condition that has increased in severity or frequency since the administration of study drug. Serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is a medically important event.

    7. Percentage of Participants with Clinically Significant Laboratory Abnormalities [Up to 30 days post last dose of study drug (up to approximately 17 months)]

    8. Cmax: Maximum Concentration for Unconjugated Drug- Monomethyl Auristatin E (MMAE) [Cycles 1, 2, 3, Day 1: Predose (at start of infusion) and end of infusion, Cycles 1, 3, Days 2, 15: At the start of infusion; Cycle 4 and subsequent cycles, Day 1: Predose (at the start of infusion) and at the end of infusion [Cycle length=21 days]]

    9. Ceoi: Plasma Concentration at the End of Infusion for Brentuximab Vedotin [Cycles 1, 2, 3, Day 1: Predose (at start of infusion) and end of infusion, Cycles 1, 3, Days 2, 15: At the start of infusion; Cycle 4 and subsequent cycles, Day 1: Predose (at the start of infusion) and at the end of infusion [Cycle length=21 days]]

    10. Percentage of Participants with Presence of Anti-Therapeutic Antibodies (ATA) to Brentuximab Vedotin [Cycles 1, 2, 3, Day 1: Predose (at start of infusion) and end of infusion, Cycles 1, 3, Days 2, 15: At the start of infusion; Cycle 4 and subsequent cycles, Day 1: Predose (at the start of infusion) and at the end of infusion [Cycle length=21 days]]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Male or female participants age 18 years or older, with relapsed or refractory sALCL who have previously received at least 1 multiagent chemotherapy

    • Bidimensional measurable disease

    • An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

    • Female participants who are postmenopausal for at least 1 year before the screening visit, surgically sterile, or agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 30 days after the last dose of study drug, or agree to practice true abstinence

    • Male participants who agree to practice effective barrier contraception during the entire study treatment period through 6 months after the last dose of study drug or agree to practice true abstinence

    • Clinical laboratory values as specified in the study protocol

    Exclusion Criteria:
    • Previous treatment with brentuximab vedotin.

    • Previously received an allogeneic transplant.

    • Participants with current diagnosis of primary cutaneous anaplastic large cell lymphoma [ALCL] (participants whose ALCL has transformed to sALCL are eligible).

    • Known cerebral/meningeal disease including signs or symptoms of progressive multifocal leukoencephalopathy (PML)

    • Female participants who are lactating and breastfeeding or pregnant

    • Known human immunodeficiency virus (HIV) positive

    • Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1ZNA StuivenbergAntwerpenBelgium2060
    2Cliniques Universitaires Saint-LucBruxellesBelgium1200
    3Universitair Ziekenhuis GentGentBelgium9000
    4UZ LeuvenLeuvenBelgium3000
    5Clinical Hospital Centre RijekaRijekaCroatia51000
    6Clinical Hospital Centre ZagrebZagrebCroatia10000
    7Clinical Hospital DubravaZagrebCroatia10000
    8Fakultni nemocnice BrnoBrnoCzechia625 00
    9Fakultni nemocnice OlomoucOlomoucCzechia779 00
    10Fakultni nemocnice Kralovske VinohradyPraha 10Czechia100 34
    11Vseobecna fakultni nemocnice v PrazePraha 2Czechia128 08
    12Semmelweis EgyetemBudapestHungary1083
    13Debreceni Egyetem Klinikai KozpontDebrecenHungary4032
    14Pecsi TudomanyegyetemPecsHungary7624
    15Uniwersyteckie Centrum KliniczneGdanskPoland80-952
    16Malopolskie Centrum Medyczne s.c.KrakowPoland30-510
    17SPZOZ MSW zWarminsko-MazurskimCen.Onko.wOlsztynieOlsztynPoland10-228
    18Centrum Onkologii-Instytut im. M. Sklodowskiej CurieWarszawaPoland02-781
    19Hospital de BragaBragaPortugal4710-243
    20Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa MariaLisboaPortugal1649-035
    21Centro Hospitalar do Porto, E.P.E. - Hospital de Santo AntonioPortoPortugal4099-001
    22Instituto Portugues de Oncologia do Porto Francisco Gentil, EPEPortoPortugal4200-072
    23Policlinica de Diagnostic Rapid SABrasovRomania500152
    24Spitalul Clinic ColentinaBucurestiRomania020125
    25Spitalul Clinic ColteaBucurestiRomania030171
    26Spitalul Clinic Judetean de Urgenta Targu MuresTargu MuresRomania540042
    27ICO lHospitalet Hospital Duran i ReynalsL'Hospitalet de LlobregatBarcelonaSpain08907
    28Hospital Universitario Marques de ValdecillaSantanderCantabriaSpain39008
    29Hospital Universitari Vall d'HebronBarcelonaSpain08035
    30Hospital Universitario Ramon y CajalMadridSpain28034
    31Hospital Universitario de SalamancaSalamancaSpain37007
    32Ankara University Medical FacultyAnkaraTurkey06340
    33Pamukkale Uni. Med. Fac.DenizliTurkey20070
    34Istanbul Bilim University Medical Fac.IstanbulTurkey34200
    35Ege University Medical FacultyIzmirTurkey35040
    36Dokuz Eylul University Faculty of MedicineIzmirTurkey35340
    37Erciyes University Medical FacultyKayseriTurkey38039
    38Royal Cornwall HospitalTruroCornwallUnited KingdomTR1 3LJ
    39The ChristieManchesterGreater ManchesterUnited KingdomM20 4BX
    40Birmingham Heartlands HospitalBirminghamWest MidlandsUnited KingdomB9 5SS

    Sponsors and Collaborators

    • Takeda
    • Takeda Development Center Americas, Inc.

    Investigators

    • Study Director: Study Director, Takeda

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Takeda
    ClinicalTrials.gov Identifier:
    NCT01909934
    Other Study ID Numbers:
    • C25006
    • 2012-004128-39
    • U1111-1154-9784
    • REec-2014-0649
    • 13/NI/0072
    First Posted:
    Jul 29, 2013
    Last Update Posted:
    Feb 22, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Takeda
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 22, 2022