Rituxan Hycela (rituximab/hyaluronidase)

P2, N=43, Recruiting, H. Lee Moffitt Cancer Center and Research Institute

P2, N=15, Active, not recruiting, Emory University | Recruiting --> Active, not recruiting | N=44 --> 15 | Trial primary completion date: Oct 2023 --> Sep 2024

P3, N=600, Not yet recruiting, National Cancer Institute (NCI)

P1, N=18, Recruiting, Canadian Cancer Trials Group | Trial completion date: Jul 2025 --> Jul 2026 | Trial primary completion date: Dec 2024 --> Dec 2025

P2, N=39, Active, not recruiting, University of Rochester | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> May 2023

P2, N=70, Recruiting, National Cancer Institute (NCI) | Initiation date: Jul 2024 --> Jan 2024

P1, N=18, Recruiting, Canadian Cancer Trials Group | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Dec 2023 --> Dec 2024

P2, N=41, Completed, ADC Therapeutics S.A. | Active, not recruiting --> Completed

P1, N=18, Terminated, Fred Hutchinson Cancer Center | N=40 --> 18 | Trial completion date: Dec 2023 --> Jul 2023 | Recruiting --> Terminated | Trial primary completion date: Dec 2023 --> Jul 2023; Closed per SRC Low Accrual Policy

P2, N=44, Recruiting, UNC Lineberger Comprehensive Cancer Center

P2, N=25, Active, not recruiting, Georgetown University | Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Oct 2023 --> Oct 2024

P1, N=30, Recruiting, Thomas Jefferson University | Suspended --> Recruiting

P2, N=70, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Trial completion date: Mar 2026 --> Oct 2026 | Initiation date: Oct 2023 --> Jul 2024 | Trial primary completion date: Mar 2026 --> Oct 2026

The first cohort (n=6) received IV rituximab, 375mg/m2 on day 1 of cycle 1 plus CHOP chemotherapy (IV cyclophosphamide 750 mg/m2, IV doxorubicin 50 mg/m2, IV vincristine 1·4 mg/m2 (maximum 2 mg/m2) on day 1, and oral prednisone 100 mg on days 1-5). As demonstrated in other parts of the world, sqR together with CHOP chemotherapy was safe, well-tolerated, and efficacious among Ugandan patients with DLBCL. The very high CR, PFS, and OS rates are nearly double that of historical controls at the UCI, and comparable to outcomes expected in resource-rich settings. Colleagues have previously demonstrated the safety and efficacy of an oral chemotherapy regimen for aggressive non-Hodgkin's lymphoma in East Africa (Mwanda et al.

P2, N=63, Active, not recruiting, Academic and Community Cancer Research United | Recruiting --> Active, not recruiting

P2; Trial primary completion date: Sep 2025 --> Aug 2024

P2, N=63, Recruiting, Academic and Community Cancer Research United | Trial completion date: Dec 2025 --> Apr 2029 | Trial primary completion date: Dec 2023 --> Apr 2027

P2; Trial completion date: Aug 2025 --> Aug 2028 | Trial primary completion date: Aug 2024 --> Sep 2025

SC rituximab improves PFS for patients with low-tumor burden FL when used in induction followed by short maintenance. High rituximab exposure during the first 3 months after treatment initiation is, however, the only parameter influencing patient outcomes.

P2, N=44, Recruiting, UNC Lineberger Comprehensive Cancer Center | Not yet recruiting --> Recruiting | Initiation date: May 2023 --> Feb 2023

P3, N=635, Active, not recruiting, Acerta Pharma BV | Recruiting --> Active, not recruiting | Trial completion date: Feb 2024 --> Oct 2025 | Trial primary completion date: Apr 2023 --> Oct 2025

P2, N=70, Not yet recruiting, National Cancer Institute (NCI)

P2; Trial completion date: Aug 2028 --> Aug 2025 | Trial primary completion date: Aug 2023 --> Aug 2024

The standard of care for DLBCL is eight cycles of intravenous (IV) rituximab combined with six or eight cycles of cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP). SC rituximab demonstrated non-inferior rituximab serum trough levels, as well as comparable efficacy and tolerability to IV rituximab in Chinese patients with previously untreated CD20+ DLBCL, indicating that SC rituximab is a viable route of administration, with potential to reduce burden of administration for healthcare professionals and patients. Non-Hodgkin's lymphoma, Diffuse large B cell lymphoma, Rituximab, DLBCL

P2, N=175, Active, not recruiting, International Extranodal Lymphoma Study Group (IELSG) | Recruiting --> Active, not recruiting

P3, N=546, Recruiting, Acerta Pharma BV | Trial completion date: Apr 2023 --> Feb 2024

P1, N=30, Suspended, Thomas Jefferson University | Recruiting --> Suspended

P2, N=5, Terminated, Epizyme, Inc. | N=59 --> 5 | Trial completion date: Sep 2026 --> Mar 2022 | Recruiting --> Terminated | Trial primary completion date: Jul 2026 --> Mar 2022; Decision to terminate EZH-1401 was solely due to company business decision.

P2, N=50, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed

All CRS events resolved (median time to resolution, 2 d; range, 1–4), no patients discontinued treatment due to CRS, and 5 patients received tocilizumab. In patients with R/R FL, subcutaneous epcoritamab + R2 demonstrated a manageable safety profile with only low-grade CRS events, mostly observed following the first full dose and all of which resolved. No new safety signals were detected. Data from this cohort are very encouraging with a high CMR rate observed in patients with R/R FL.

P1, N=40, Recruiting, Fred Hutchinson Cancer Center | Trial completion date: May 2023 --> Dec 2023 | Trial primary completion date: May 2023 --> Dec 2023

The results confirmed the effectiveness and safety of rituximab SC in both the FL and the DLBCL group. Satisfaction of patients and nurses with SC administration was high.

P2, N=60, Completed, Diako Ev. Diakonie-Krankenhaus gemeinnützige GmbH | Active, not recruiting --> Completed | Trial completion date: Dec 2022 --> Jul 2022

This review indicated a substantial body of evidence showing time/resource and cost savings of SC versus IV administration of oncology biologics in a hospital setting, which can be used to inform economic evaluations of PH FDC SC.

All CRS events resolved with standard management, including tocilizumab in 3 pts, and 1 pt discontinued Tx due to CRS. Subcutaneous epcoritamab + R2 exhibits promising efficacy, including a high CMR rate, in pts with R/R FL. The safety profile was consistent with prior data, and CRS events were generally low grade and in C1. Updated data will be presented.

P2, N=50, Active, not recruiting, Hoffmann-La Roche | Trial primary completion date: Aug 2022 --> May 2022

P3, N=626, Recruiting, Acerta Pharma BV | Trial completion date: Nov 2022 --> Apr 2023 | Trial primary completion date: Nov 2022 --> Apr 2023

P2 | N=45 | Recruiting | Sponsor: Academic and Community Cancer Research United | Not yet recruiting --> Recruiting

The switch from IV to SC rituximab in patients with DLBCL and FL was associated with low risk of ARRs and satisfactory response in both groups. This trial was registered with NCT01987505.

P2, N=50, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting

P2, N=63, Recruiting, Academic and Community Cancer Research United | Not yet recruiting --> Recruiting

The second generation BTK inhibitor acalabrutinib (ACALA) has demonstrated an improved safety profile compared to ibrutinib. HFLD RTX and ACALA is a tolerable, effective and convenient therapy that could be the basis for regimens incorporating other novel agents. It is notable that three patients have contracted COVID-19 during the trial; however, none required intubation, and all remained on ACALA during their infection. This at-home combination markedly decreased patient infection risk during the COVID-19 pandemic.