Adcetris (brentuximab vedotin)

P2, N=50, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Oct 2025 --> Oct 2027

This case presents a patient who developed KIN with a progressively rising serum creatinine after ifosfamide, carboplatin and brentuximab treatment. Although ifosfamide and carboplatin have known associations with the development of KIN, this case raises the possibility that brentuximab, which has a different mechanism of action, also may be associated with KIN. Additionally, the genetic findings demonstrate that drug-induced KIN can develop in the absence of FAN1 mutations, a finding not previously reported.

This case underscores the importance of early biopsy and molecular testing when standard treatments fail. Early recognition and routine examinations, including lymph node assessments and skin biopsies, are critical for improving patient outcomes, as timely diagnosis leads to more effective treatment options and potential remission.

The promising clinical efficacy observed warrants further investigation, and development of acimtamig for patients with R/R CD30+ lymphomas continues in combination with allogeneic natural killer cells.

P2, N=155, Active, not recruiting, City of Hope Medical Center | Trial completion date: Sep 2024 --> Dec 2024 | Trial primary completion date: Sep 2024 --> Dec 2024

P2, N=26, Active, not recruiting, John Reneau | Trial completion date: Apr 2024 --> May 2025 | Trial primary completion date: Apr 2024 --> May 2025

No abstract available

Objective: To evaluate the efficacy and safety of brentuximab vedotin (BV) combined with rituximab and attenuated chemotherapy in the treatment of children with classic Hodgkin lymphoma (cHL). At 6 and 9 months of follow-up, IgA, IgG, IgM and total B cell counts returned to pre-chemotherapy baseline levels, respectively. BV combined with rituximab attenuated chemotherapy has demonstrated efficacy and a tolerable safety profile in the treatment of cHL in children, and significantly reduce radiation rate.

P2, N=255, Terminated, Seagen Inc. | Trial completion date: Jun 2026 --> Aug 2024 | Active, not recruiting --> Terminated; The study was prematurely discontinued as the sponsor believes the data collected is enough to show the safety and efficacy of the combinations studied in all cohorts. The decision was not based on any safety and/or efficacy concerns.

P1/2, N=146, Active, not recruiting, National Cancer Institute (NCI) | Suspended --> Active, not recruiting

Overall, EPOCH was well tolerated with high response rates in first line and R/R setting.

P2, N=82, Active, not recruiting, Seagen Inc. | Trial completion date: Sep 2024 --> Dec 2025 | Trial primary completion date: Sep 2024 --> May 2024

In patients with CD30-expressing CTCL, Brentuximab Vedotin has demonstrated better response rates and progression-free survival (PFS); in advanced SS, mogamulizumab has significantly increased PFS. These findings emphasize the need to standardize prognostic factors and improve CTCL treatment.

P4, N=10, Completed, Takeda | Active, not recruiting --> Completed

P1, N=10, Recruiting, University of Alabama at Birmingham | Trial completion date: Jun 2025 --> Jul 2026 | Trial primary completion date: Dec 2024 --> Apr 2026

P2, N=40, Recruiting, University of Washington | Trial completion date: Sep 2025 --> Mar 2026 | Trial primary completion date: Sep 2024 --> Mar 2025

P2, N=31, Recruiting, City of Hope Medical Center | Trial completion date: Oct 2024 --> Oct 2026 | Trial primary completion date: Oct 2024 --> Oct 2026

Signals for peripheral sensory neuropathy were 4.83, 2.44, 2.74, and 2.21 (calculated based on IC025) for brentuximab vedotin, trastuzumab emtansine, enfortumab vedotin, and polatuzumab vedotin, while signals for peripheral motor neuropathy were 5.31, 0.34, 2.27, and 0.03, respectively...Tisotumab vedotin had the highest hospitalization rate at 26.67%, followed by brentuximab vedotin at 25.5%...Brentuximab vedotin and enfortumab vedotin showed similar profiles for peripheral sensory neuropathy and motor neuropathy. Given the delayed time to onset and potentially poor outcomes, ADC-related peripheral neuropathy warrants significant attention.

In Japan, 4 drugs are approved as ADCs for leukemia and lymphoma: gemtuzumab ozogamicin(GO)consists of an anti-CD33 monoclonal antibody bound to calicheamicin via a linker, approved for relapsed/refractory acute myeloid leukemia. Brentuximab vedotin (BV)has anti-CD30 antibodies bound to MMAE via a linker and is approved for CD30-positive Hodgkin's lymphoma, peripheral T-cell lymphoma, and cutaneous T-cell lymphoma...Inotuzumab ozogamicin(IO)has an anti-CD22 antibody bound to calicheamicin via a linker, approved for relapsed/refractory CD22-positive B-cell acute lymphoblastic leukemia...Polatuzumab vedotin(PV)has an anti-CD79b monoclonal antibody bounds to MMAE via a linker, approved for diffuse large B-cell lymphoma(DLBCL). In DLBCL patients with an international prognostic index score(IPI score)of 2 or higher, the combination of PV plus rituximab, cyclophosphamide, doxorubicin, and prednisone(PV+R-CHP)extended PFS at 2 years compared with R-CHOP(rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone), which has long been the standard of care. As shown, ADCs exhibit high therapeutic efficacy in leukemia and lymphoma treatment, but many aspects of their resistance mechanisms remain unclear and require further research.

P2, N=100, Recruiting, Chinese PLA General Hospital | N=60 --> 100

P2, N=70, Completed, University of Cologne | Active, not recruiting --> Completed

P2, N=100, Not yet recruiting, Chinese PLA General Hospital

Potential mechanisms include BV targeting CD30+ T cells in the uveal tissue or an immune response triggered by the microtubule-disrupting agent MMAE within BV. This highlights the need for vigilant monitoring of ocular adverse events in BV-treated patients and further research into their mechanisms and management.

P2/3, N=96, Not yet recruiting, Children's Cancer Group, China

P=N/A, N=50, Recruiting, Takeda | Trial completion date: Jun 2024 --> Sep 2024 | Trial primary completion date: Jun 2024 --> Sep 2024

While the initial presentation mimicked an infectious process, the biopsy revealed a possible cutaneous anaplastic T-cell lymphoma. Further investigations are necessary to definitively classify the specific lymphoma subtype and guide further treatment decisions.

Aberrant CD20 expression in MF is rare but indicates a progressive course associated with poor prognosis. This often requires systemic chemotherapy and, in certain instances, allogeneic hematopoietic stem cell transplantation. This study provides important insights into the clinical attributes, disease progression, and treatment options for MF patients with aberrant CD20 expression. Further research is necessary to validate the effectiveness of emerging therapies and enhance our understanding of the underlying mechanisms and prognostic determinants specific to this unique MF subgroup.

P2, N=46, Active, not recruiting, Academic and Community Cancer Research United | Trial completion date: May 2024 --> Sep 2024

In patients with mostly CD30-expressing peripheral T-cell lymphomas other than non-anaplastic large-cell lymphoma, CHEP-BV (with or without autologous HSCT) followed by brentuximab vedotin consolidation was safe and active.

No abstract available

P2, N=28, Recruiting, Deepa Jagadeesh | Trial completion date: Jun 2027 --> Dec 2027 | Trial primary completion date: Jun 2024 --> Dec 2024

BV + CsA demonstrated modest activity in BV-refractory r/r HL; however, toxicity is substantial.

A total of 28 cases of grade 3 or above adverse events were recorded, mainly myelosuppression, all of which were related to chemotherapy and did not affect sequential treatment. Brentuximab vedotin has demonstrated efficacy and a tolerable safety profile in the treatment of refractory and relapsed CD30-positive Hodgkin's lymphoma in children.

P1, N=4, Recruiting, The First Affiliated Hospital of Soochow University

P2; Trial completion date: May 2024 --> Dec 2024

He received six cycles of the Adriamycin, Bleomycin, Vinblastine, Dacarbazine (ABVD) regimen, achieving complete clinical remission. The patient underwent two cycles of chemotherapy with brentuximab vedotin and the Gemcitabine-Oxaliplatin (G-mox) regimen, resulting in a reduction of the skin lesions to 2 cm × 1 cm. We discuss this rare case and review related literature.

P=N/A, N=50, Not yet recruiting, The First Affiliated Hospital of Zhejiang University School of Medicine; The First Affiliated Hospital of Zhejiang University School of Medicine

P=N/A, N=51, Completed, Takeda | Active, not recruiting --> Completed | Trial completion date: Jun 2024 --> Sep 2023

P2, N=72, Completed, Bristol-Myers Squibb | Active, not recruiting --> Completed | Trial completion date: Nov 2024 --> May 2024

P2, N=30, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Jun 2024 --> Jan 2026 | Trial primary completion date: Jun 2024 --> Jan 2026

A variable change in pNfL is observed depending on the type of agent and mechanism of neurotoxicity with comparable CIPN severity, strongly implying the need to identify different cutoff values for each agent.

The results suggest a circulating tumor-immune-derived signature of BV±I+N treatment resistance that may be useful for patient stratification in combination checkpoint therapy.