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    Association details:
    Biomarker:TNFRSF8 positive
    Cancer:Hodgkin Lymphoma
    Drug:Adcetris (brentuximab vedotin) (Microtubule inhibitor, CD30-targeted antibody-drug conjugate)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Takeda Press Release
    Title:

    European Commission Approves ADCETRIS® (brentuximab vedotin) for the Treatment of Adult Patients with Previously Untreated CD30+ Stage III Hodgkin Lymphoma in Combination with AVD

    Published date:
    10/18/2023
    Excerpt:
    Takeda (TSE:4502/NYSE:TAK) today announced that the European Commission (EC) approved ADCETRIS® (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) to treat adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma.
    Secondary therapy:
    AVD
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    European Medicines Agency
    Published date:
    10/25/2012
    Excerpt:
    Adcetris is indicated for adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD).
    Secondary therapy:
    dacarbazine + vinblastine
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    European Medicines Agency
    Published date:
    10/25/2012
    Excerpt:
    Adcetris is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following autologous stem cell transplant (ASCT).
    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:
    ...• All patients with histologically proven CD30-positive (i.e. > 1% cells) lymphomas who will be treated with brentuximab vedotin, including:o Hodgkin lymphomao T-cell lymphomao Cutaneous T-cell lymphomao DLBCL• Age ≥18• Signed written informed consent form (approved by the Institutional Review Board [IRB]/ Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures• Measurable disease: on CT scan at least 1 lesion/node with a long axis of > 1.5 cm and at least one positive lesion on 18F-FDG PET scan u2028• WHO performance status 0-2 (see appendix A) u2028• Adequate hepatic function: total bilirubin ≤ 1.5 times ULN (unless due to lymphoma involvement of the liver or a known history of Gilbert's syndrome as defined by > 80% unconjugated bilirubin) and ALAT/ASAT ≤ 3 times ULN (unless due to lymphoma involvement of the liver; in that case ALAT/ASAT may be elevated up to 5 times ULN)• Adequate renal function: GFR > 50 ml/min as estimated by the Cockroft&Gault formula at rehydration: CrCL = (140-age [in years] x weight [kg] (x 0.85 for females) (0.815 x serum creatinine [μmol/L]) u2028• Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L and platelet count ≥100 x 109/L, unless caused by diffuse bone marrow infiltration by lymphoma• Hemoglobin must be ≥ 8 g/dL (5.0 mmol/L), transfusion is allowed u2028• Life expectancy of >3 months with treatment u2028• Negative pregnancy test at study entry, if applicable • Alle patiënten met histologisch bewezen CD30-positieve (d.w.z. ...
    Trial ID:
    2021-005950-27
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Spanish Medical Record Review of Adults With Relapsed or Refractory CD30+ Malignancies When Re-treated With Brentuximab-vedotin

    Excerpt:
    ...Histologically confirmed cHL, CTCL (MF and pcALCL) or sALCL with CD30 positive....
    Trial ID:
    BELIEVE
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma

    Excerpt:
    ...- Histologic diagnosis of classical, CD30 positive Hodgkin lymphoma confirmed at enrolling institution...
    Trial ID:
    NCT01868451
    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:
    ...Maximum tolerated dose, dose-limiting toxicities of the combination therapy, and recommended phase 2 dose, in patients with relapsed/refractory cutaneous T-cell lymphoma, CD30-positive Hodgkin lymphoma and CD30-positive peripheral T-cell lymphoma. ...
    Trial ID:
    EpiBrentlen
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Brentuximab Vedotin as Alternative to the Autologous Stem Cell Transplantation in Relapsed and Refractory Classical Hodgkin's Lymphoma (BASALT)

    Excerpt:
    ...Patients must have a diagnosis of a morphologically confirmed cluster of differentiation antigen 30 {CD30)-positive classical Hodgkin's lymphoma with primary refractory course or relapse after adequate first-line chemotherapy (with morphologically confirmation of vital tumor) 6....
    Trial ID:
    BASALT
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Cardiac Safety Study of Brentuximab Vedotin (SGN-35)

    Excerpt:
    ...- Relapsed or refractory CD30-positive malignancy...
    Trial ID:
    NCT01026233
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Brentuximab Vedotin After Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies

    Excerpt:
    ...- Patients must have a cluster of differentiation (CD)30+ malignancy, with CD30 positivity demonstrated either at time of original diagnosis or at any subsequent time point...
    Trial ID:
    NCT01620229
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With Stage II-IV HIV-Associated Hodgkin Lymphoma

    Excerpt:
    ...- Histologic diagnosis of CD30-positive classical HL as defined by the 2008 World Health Organization (WHO) Classification of Hematological diseases; nodular lymphocyte predominant Hodgkin lymphoma is...
    Trial ID:
    NCT01771107
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Survey of Brentuximab Vedotin in Pediatric Participants With Hodgkin Lymphoma

    Excerpt:
    ...CD30 positive participants 3....
    Trial ID:
    NCT05481437
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Special Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Relapsed or Refractory CD30-positive Peripheral T Cell Lymphoma or Pediatric Hodgkin Lymphoma"

    Excerpt:
    ...CD30-positive participants....
    Trial ID:
    NCT04213209
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Brentuximab Vedotin (SGN-35) in Transplant Eligible Patients With Relapsed or Refractory Hodgkin Lymphoma

    Excerpt:
    ...- Histologic diagnosis of cd30 positive classical Hodgkin's lymphoma....
    Trial ID:
    NCT01508312
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Untreated CD30-Positive Hodgkin's Lymphoma"

    Excerpt:
    ...CD30-positive participants 3....
    Trial ID:
    NCT03729609
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Pilot Trial of AVD and Brentuximab Vedotin (SGN-35) in the Treatment of Stage III-IV HIV-associated Hodgkin Lymphoma

    Excerpt:
    ...Histologic diagnosis of CD30-positive classical HL as defined by the 2008 WHO Classification of Hematological diseases....
    Trial ID:
    AMC-085
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Brentuximab Vedotin in the Elderly Hodgkin Lymphoma Patients at First Relapse or With Primary Refractory Disease.

    Excerpt:
    ...Histologically confirmed CD30-positive disease 2....
    Trial ID:
    FIL BVHD01
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Brentuximab Vedotin in High-Risk CD30+ Lymphoma Post Allogeneic Stem Cell Transplantation (AlloSCT)

    Excerpt:
    ...Patients with CD30 positive Hodgkin Lymphoma (HL) or anaplastic large cell lymphoma (ALCL) that have undergone allogeneic or haploidentical SCT in the past 60 days (matched related or matched unrelated donors only)....
    Trial ID:
    NCT02169505
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Brentuximab Vedotin in Patients With Hodgkin Lymphoma Unsuitable for Chemotherapy Due to Age, Frailty or Co-morbidity

    Excerpt:
    ...Histologically confirmed CD30 positive classical Hodgkin lymphoma 2....
    Trial ID:
    BREVITY
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma

    Excerpt:
    ...- Histologically confirmed CD30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block....
    Trial ID:
    NCT00848926
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study

    Excerpt:
    ...- CD30-positive hematologic malignancy....
    Trial ID:
    NCT00947856
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)

    Excerpt:
    ...- Relapsed or refractory CD30-positive malignancy...
    Trial ID:
    NCT01026415
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies

    Excerpt:
    ...- Patients must have histologically confirmed CD30-positive hematologic malignancy....
    Trial ID:
    NCT00430846
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine for CD30-Positive Malignancies

    Excerpt:
    ...- Histologically confirmed CD30-positive hematologic malignancy....
    Trial ID:
    NCT00649584
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2022
    Title:

    Updated safety and efficacy data from an open-label, phase 1/2 study of frontline brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine (A+AVD) in pediatric patients with advanced-stage classical Hodgkin lymphoma (cHL)

    Published date:
    05/26/2022
    Excerpt:
    Brentuximab vedotin given at 48 mg/m2 every two weeks in combination with AVD had an acceptable safety profile and was associated with an efficacy benefit in CD30+, treatment-naïve pediatric patients with advanced cHL, supporting A+AVD as a frontline treatment option for this patient population.
    Secondary therapy:
    AVD
    DOI:
    10.1200/JCO.2022.40.16_suppl.10000
    Trial ID:
    C25004
    Evidence Level:
    Sensitive: C3 – Early Trials
    New
    Source:
    BMC Hematol
    Title:

    Retreatment with brentuximab vedotin in patients with CD30-positive hematologic malignancies

    Excerpt:
    Retreatment with brentuximab vedotin monotherapy was investigated in patients with CD30-positive Hodgkin lymphoma (HL) or systemic anaplastic large cell lymphoma (ALCL)...The objective response rate was 60% (30% CR) in HL patients and 88% (63% CR) in systemic ALCL patients....Retreatment with brentuximab vedotin monotherapy is associated with response rates in 68% (39% CR) of patients with relapsed HL and systemic ALCL.
    DOI:
    https://doi.org/10.1186/1756-8722-7-24
    Trial ID:
    NCT00947856
    Evidence Level:
    Sensitive: C4 – Case Studies
    Source:
    HEMO 2020
    Title:

    BRENTUXIMABE IN MONOTHERAPY FOR AN ELDERLY PATIENT WITH RECURRED HODGKIN LYMPHOMA: CASE REPORT.

    Published date:
    11/26/2020
    Excerpt:
    ...71 years old, diabetic, ex-alcoholic, heavy smoker, with COPD and heart failure, with a history of mixed cellularity LH diagnosed 7 years ago...late recurrence of mixed CD30 positive LH, stage IIIB...Alternatively, BV was started on monotherapy every 3 weeks. The patient has already performed 8 of the 16 planned BV cycles, showing complete response after the third cycle, with significant clinical improvement...
    DOI:
    10.1016 / j.htct.2020.10.342