^
    Back
    Association details:
    Biomarker:TNFRSF8 expression
    Cancer:T Cell Non-Hodgkin Lymphoma
    Drug:Adcetris (brentuximab vedotin) (Microtubule inhibitor, CD30-targeted antibody-drug conjugate)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Blood Adv
    Title:

    Randomized phase 3 ALCANZA study of brentuximab vedotin vs physician's choice in cutaneous T-cell lymphoma: final data

    Published date:
    09/10/2021
    Excerpt:
    Adults with previously treated CD30-expressing MF/C-ALCL were randomized to brentuximab vedotin (n = 64) or physician's choice (n = 64). Final data demonstrated improved responses per independent review facility with brentuximab vedotin vs physician's choice: ORR4, 54.7% vs 12.5% (P < .001); complete response, 17.2% vs 1.6% (P = .002)....Adults with previously treated CD30-expressing MF/C-ALCL were randomized to brentuximab vedotin (n = 64) or physician's choice (n = 64). Final data demonstrated improved responses per independent review facility with brentuximab vedotin vs physician's choice: ORR4, 54.7% vs 12.5% (P < .001); complete response, 17.2% vs 1.6% (P = .002).
    DOI:
    10.1182/bloodadvances.2021004710
    Trial ID:
    ALCANZA
    Evidence Level:
    Sensitive: C1 - Off-label
      (Approved for Peripheral T-cell Lymphoma)
    New
    Excerpt:
    ADCETRIS is a CD30-directed antibody-drug conjugate indicated for treatment of adult patients with:...Previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone.
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    A phase 2 study of retreatment with brentuximab vedotin in subjects with classic Hodgkin lymphoma or CD30-expressing peripheral T cell lymphoma Studio di fase 2 di ritrattamento con brentuximab vedotin in soggetti affetti da linfoma di Hodgkin classico o linfoma periferico a cellule T CD30-positivo

    Excerpt:
    ...- Histologically confirmed cHL, sALCL, or other CD30-expressing PTCL.- Previously treated with brentuximab vedotin containing regimen, with evidence of objective response, and subsequent disease progression orrelapse after discontinuing treatment.- Documentation of disease relapse or progression > o = 6 months after the last dose of brentuximab vedotin.- Fluorodeoxyglucose positron emission tomography- (FDG-PET) avid and bidimensional measurable disease of at least 1.5 cm in longest axisas documented by radiographic technique.- An Eastern Cooperative Oncology Group (ECOG) performance status < o = 2.- Must not be pregnant and, if of childbearing or fathering potential, must agree to use 2 effective contraception methods during study andfor 6 months following last dose of study drug.- Age 18 or older.Other protocol defined inclusion criteria may apply. ...
    Trial ID:
    2019-003983-28
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression

    Excerpt:
    ...- CD30 expression <10% by local assessment in tumor containing lymph node or other extranodal soft tissue biopsy...
    Trial ID:
    NCT04569032
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorubicin), Prednisone (CHP) in Chinese Participants With CD30-Positive (CD30+) Peripheral T-Cell Lymphomas (PTCL)

    Excerpt:
    ...Tumor specimen must be submitted before enrollment for subsequent central pathology review to confirm histology (and anaplastic lymphoma kinase (ALK) status, if applicable), and CD30 expression....
    Trial ID:
    NCT05673785
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    SGN-35 in CD30-positive Lymphoproliferative Disorders (ALCL), Mycosis Fungoides (MF), and Extensive Lymphomatoid Papulosis (LyP)

    Excerpt:
    ...Response rate is percentage of participants with skin lesions that express CD30+ receiving SGN-35 in primary cutaneous ALCL, MF, and extensive lymphomatoid papulosis whose best response during the observation period is a Partial Response (PR), regression of measurable disease, or Complete Response (CR), complete disappearance of all clinical evidence of disease, (i.e. at least moderate improvement). ...
    Trial ID:
    NCT01352520
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)

    Excerpt:
    ...- Treatment-naive patients with CD30-expressing PTCL (Part F)...
    Trial ID:
    SGN35-015
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Brentuximab Vedotin and Lenalidomide in Patients With Relapsed/ Refractory T-cell Lymphoma or Hodgkin Lymphoma

    Excerpt:
    ...Patients with either Hodgkin lymphoma or T-cell lymphoma must have expression of CD30 in ≥10% of lymphoma cells....
    Trial ID:
    EpiBrentlen
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Brentuximab Vedotin in Combination With CHEP in Patient With PTCL

    Excerpt:
    ...Histologically confirmed diagnosis of CD30-expressing PTCL....
    Trial ID:
    PTCL-CHEPA
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Brentuximab Vedotin and Lenalidomide in Treating Patients With Relapsed or Refractory T-Cell Lymphomas

    Excerpt:
    ...Rate of objective global response defined as proportion of patients achieving complete response (CR)/partial response (PR) that lasts at least 4 months`Complete response defined as proportion of patients achieving CR according to Olsen criteria`Progression free survival (PFS) according to Olsen criteria`Change in pruritus visual analogue scale (VAS)`CD30 expression assessed by lymph node and/or skin biopsies via immunochemistry...
    Trial ID:
    NCT03373305
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Pilot Study of Brentuximab Vedotin in Relapsed/Refractory Peripheral T-Cell Lymphoma Expressing CD30

    Excerpt:
    ...- Confirmed diagnosis of PTCL expressing CD30 receptor....
    Trial ID:
    NCT01841021
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides With Variable CD30 Expression Level

    Excerpt:
    ......
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Imaging study with brentuximab in patients with lymphoma Beeldvormend onderzoek met brentuximab bij patiënten met lymfeklierkanker

    Excerpt:
    ...• A feasible and optimized 89Zr-brentuximab imaging protocol in patients with CD30+ lymphomas• Safety profile, pharmacokinetics (PK), and pharmacodynamics (PD) of the tracer 89Zr-brentuximab• The relationship between 89Zr-brentuximab biodistribution (tumor uptake) and CD30 protein expression (IHC), soluble CD30 measurements (ELISA), as well as CD30 RNA expression (nanostring). ...
    Trial ID:
    2021-005950-27
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    An open-label, phase 2 study of brentuximab vedotin and Chemotherapy agents in the frontline treatment of subjects with peripheral T-cell lymphoma (PTCL) Étude en ouvert, de phase 2 à double cohorteportant sur le brentuximab védotine et les agents de chimiothérapie dans le traitement de première ligne de patients atteints de lymphome à cellules T périphérique (LCTP)

    Excerpt:
    ...3.The following non-sALCL PTCL subtypes are eligible: a.PTCL – not otherwise specified (PTCL-NOS) b.Angioimmunoblastic T-cell lymphoma (AITL) c.Adult T-cell leukemia/lymphoma (ATLL; acute and lymphoma types only, must be positive for human T cell leukemia virus 1) d.Enteropathy-associated T-cell lymphoma (EATL) e.Hepatosplenic T-cell lymphoma f.Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITCL) g.Indolent T-cell lymphoproliferative disorder (T-LPD) of the gastrointestinal (GI) tract h.Follicular T-cell lymphoma i.Nodal peripheral T-cell lymphoma with T-follicular helper (TFH) phenotype 4.CD30 expression <10% by local assessment 5.Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT, as assessed by the site radiologist. ...
    Trial ID:
    2020-002336-74
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma

    Excerpt:
    ...- Histologically confirmed cHL, sALCL, or other CD30-expressing PTCL...
    Trial ID:
    NCT03947255
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    The standard of care for patients with newly diagnosed CD30-positive PTCL is treatment with a combination of drugs called CHOP. This study is conducted to improve the effectiveness of CHOP chemotherapy with combination therapy, in which vincristine is replaced by brentuximab vedotin. Also, the addition of etoposide to various chemotherapy regimens for T-lymphomas has been associated with promising results in several other studies. This combination is called A + CHEP. Standardem péče pro pacienty s nově zjištěným CD30 pozitivním PTCL je léčba kombinací léků zvaných CHOP. Tato studie se provádí s cílem zlepšit účinnost chemoterapie CHOP s kombinovanou léčbou, v níž se vinkristin nahradí přípravkem brentuximab vedotin. Taktéž přidání etoposidu do různých režimů chemoterapie u T-lymfomů bylo v několika dalších studiích spojeno se slibnými výsledky. Tato kombinace se nazývá A+CHEP [brentuximab vedotin plus cyklofosfamid, doxorubicin, etoposid, prednison].

    Excerpt:
    ...Histologically confirmed diagnosis of CD30-expressing PTCL. ...
    Trial ID:
    2021-003526-80
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma

    Excerpt:
    ...Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Plus Rituximab`Complete Remission (CR) Rate by Investigator`Duration of Objective Response With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis`Duration of Complete Remission With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis`Progression-Free Survival With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis`Correlation Between Antitumor Activity of Brentuximab Vedotin Monotherapy and CD30 Expression`Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Monotherapy`Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) (Cycle 1)`Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) (Cycle 1)`Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) (Cycle 1)`Time to Maximum Concentration (Tmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)`Baseline Soluble CD30 Expression...
    Trial ID:
    NCT01421667