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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:
Source:
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:
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.
Source:
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:
Source:
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:
More C2 evidence
Source:
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:
Source:
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:
Source:
Title:
A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression
Excerpt:
...- CD30 expression ...
Trial ID:
Source:
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:
Source:
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:
Source:
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:
Source:
Title:
Brentuximab Vedotin in Combination With CHEP in Patient With PTCL
Excerpt:
...Histologically confirmed diagnosis of CD30-expressing PTCL....
Trial ID:
Source:
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:
Source:
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:
Source:
Title:
Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides With Variable CD30 Expression Level
Excerpt:
......
Source:
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:
Source:
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:
Source:
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 = 6 mesi dopo l’ultima dose di brentuximab vedotin.- Malattia misurabile mediante tomografia ad emissione di positroni a base di fluorodesossiglucosio (FDG-PET) avidae bidimensionale di almeno 1,5 cm nell’asse più lungo come documentato dalla tecnica radiografica.- Stato di performance secondo l’Eastern Cooperative Oncology Group (ECOG) < o = 2- Non deve avere una gravidanza in corso e, se in età fertile o soggetto maschile in grado di concepire,deve accettare di utilizzare 2 metodi contraccettivi efficaci nel corso dello studio e per 6 mesi dopo l’ultima dose del farmaco dello studio.- Età o superiore a 18 anni.Potrebbero applicarsi criteri di inclusione aggiuntivi definiti dal protocollo....
Trial ID:
