bendamustine

P=N/A, N=100, Active, not recruiting, IRCCS Azienda Ospedaliero-Universitaria di Bologna

P1/2, N=543, Active, not recruiting, Genmab | Recruiting --> Active, not recruiting

P2, N=360, Active, not recruiting, ECOG-ACRIN Cancer Research Group | Trial completion date: Mar 2025 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025

P2, N=141, Active, not recruiting, Fondazione Italiana Linfomi - ETS | Trial completion date: Jul 2025 --> Nov 2025

Adverse events were as expected with zanubrutinib; rate of atrial fibrillation was 7.1%. At a median follow-up of 61.2 months, the results supported the initial SEQUOIA findings and suggested that zanubrutinib was a favorable treatment option for untreated patients with CLL/SLL.

Uni- and multi-variate analyses of clinical variables that may be associated with clinical and MRD outcomes are underway.Conclusions : Bendamustine, rituximab and acalabrutinib front-line therapy for WM is safe and well tolerated in a relatively elderly population with a toxicity profile consistent with the utilized drugs and not greater than that seen with BR and Placebo in the randomized ECHO trial in untreated Mantle Cell Lymphoma. Initial clinical results show that this treatment is associated with a very high proportion of CR + VGPRs as well as MRD negativity.

P1, N=28, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025

P3, N=1080, Recruiting, Genmab | Trial completion date: May 2037 --> Nov 2037 | Trial primary completion date: May 2037 --> Nov 2037

P2, N=168, Active, not recruiting, Miltenyi Biomedicine GmbH | Trial completion date: Jul 2027 --> Jul 2029

P3, N=124, Not yet recruiting, SecuraBio | Initiation date: Dec 2024 --> Mar 2025

Notably, a reduction in CD4 + T cells, predominantly contributing to treatment-related T-cell reduction, was only observed in patients undergoing Bendamustine-based regimens...Overall, FL patients demonstrated compromised T-cell immunity, with a lower CD4 + T cell count at diagnosis correlating with treatment response and early progression. Therefore, monitoring CD4 + T cells at diagnosis might reflect immune status and aid in stratifying FL patients.

P1, N=20, Completed, Noah Merin | Active, not recruiting --> Completed | N=30 --> 20 | Trial completion date: Nov 2031 --> Nov 2024

ABR provides this clinical benefit without excess toxicity as shown by attenuated differences between arms in exposure-adjusted incidence rates, suggesting that higher AE rates in the ABR arm are likely due in part to the longer duration of acalabrutinib treatment vs placebo. These data emphasize the benefits of acalabrutinib in frontline MCL treatment in high-risk pts and the additional benefit of continuous therapy.

We recently demonstrated that INO can be added safely to a non-myeloablative conditioning of bendamustine, fludarabine, and rituximab in patients with indolent lymphoid malignancies who required an allogeneic hematopoietic transplantation (HCT) (Am J Hematol 2024)...Patients who received transplants from MUDs received an additional dose of methotrexate 5 mg/m2 on day +11 and 1 mg/kg of rabbit anti-thymocyte globulin IV on days -1 and -2 before HCT...The patient who was in CR2 at transplant had Ph+ ALL and was maintained on ponatinib after HCT. Key prior therapies in ALL patients included blinatumomab (n=5) and INO (n=5)...The survival outcomes are encouraging and need to be validated in a larger number of patients. Currently, post-transplant cyclophosphamide has been implemented to lessen the risk of GVHD.

Induction with 3 cycles of bendamustine and rituximab followed by 3 cycles of cytarabine and rituximab (BR/CR) is associated with high complete metabolic response (CMR) and uMRD rates (Armand et al., BJH 2016; Merryman et al., Blood Adv 2020). Bruton's tyrosine kinase inhibitors (BTKi) including ibrutinib and acalabrutinib (A) in combination with CIT are highly effective in MCL (Wang et al., EHA 2024, LBA 3439)...Addition of acalabrutinib to the standard arm added toxicity without improvement in efficacy, suggesting acalabrutinib should be avoided during Ara-C cycles. BR-A was found not superior and closed early by the DSMC; however, it is the least toxic arm with similar efficacy, and represents an appealing option to avoid high dose cytarabine.

P1, N=9, Active, not recruiting, Fred Hutchinson Cancer Center | Recruiting --> Active, not recruiting | N=15 --> 9

A 75-year-old man presented with uveitis masquerade syndrome while undergoing treatment for MCL with rituximab-bendamustine. During the study course, CD5 and CD20 positive cells were identified in the anterior chamber of the eyes via flow cytometry, which was consistent with the pathological findings of biopsies. Ibrutinib may improve recurrent MCL intraocular lesions.

Patients who received bendamustine required more platelet transfusions (p = 0.02)...Conditioning with BEAM and BeEAM regimens is associated with comparable post-transplant outcomes. The toxicity of these regimens is comparable; however, BEAM is associated with a higher risk of pneumonia, while BeEAM is associated with a higher risk of mucositis.

P1, N=12, Recruiting, Mayo Clinic | Not yet recruiting --> Recruiting

P1, N=25, Recruiting, Mayo Clinic | Trial completion date: Dec 2025 --> Mar 2026 | Trial primary completion date: Dec 2024 --> Mar 2025

P2, N=50, Completed, St. Petersburg State Pavlov Medical University | Recruiting --> Completed | Trial completion date: Dec 2024 --> May 2024 | Trial primary completion date: Dec 2023 --> May 2024

However, bendamustine + rituximab had a more favorable safety profile for grade ⩾3 AEs when compared with ibrutinib (risk ratio 0.62 (95% credible interval 0.40-0.86)), acalabrutinib (0.69 (0.45-0.94)), zanubrutinib (0.64 (0.42-0.91)), and venetoclax + rituximab (0.87 (0.79-0.96)). Our findings showed that venetoclax + rituximab, acalabrutinib, and zanubrutinib have acceptable safety profiles, which indicates that they may be the preferred therapeutic options in the setting of relapsed/refractory CLL. PROSPERO CRD42022304330.

P2, N=24, Not yet recruiting, Fox Chase Cancer Center | Initiation date: Sep 2024 --> Dec 2024

P3, N=86, Active, not recruiting, The Lymphoma Academic Research Organisation | Trial completion date: Jun 2024 --> Dec 2024

P3, N=1030, Completed, The Lymphoma Academic Research Organisation | Active, not recruiting --> Completed

P3, N=1080, Recruiting, Genmab | Trial primary completion date: Jan 2030 --> May 2037

In this study, we have shown the cytotoxicity of BDM alone and in combination with novel agents including the histone deacetylase (HDAC) inhibitor tucidinostat, the enhancer of zeste homolog 1/2 (EZH1/2) dual inhibitor valemetostat, and the Bcl2 family inhibitor ABT-737. Our present results suggest that the combination of tucidinostat and BDM could additively prolong the survival of patients with R/R progressive ATL. The efficacy and safety of this combination are thus worthy of investigation in clinical settings.

Our results encourage the pursuit of clinical trials of combined treatment with NL101 and venetoclax and provide a novel venetoclax-incorporating therapeutic strategy for AML.

P1/2, N=170, Active, not recruiting, Cyteir Therapeutics, Inc. | Trial completion date: Dec 2024 --> Apr 2025 | Trial primary completion date: Jul 2024 --> Dec 2024

The patient received bendamustine and rituximab as chemotherapy, which rapidly improved the anemia and splenomegaly and reduced atypical lymphocytes. An autopsy revealed that the tumor had invaded several organs including the pancreas, and immunohistochemistry was positive for CD163, leading to the diagnosis of HS. Furthermore, the specimens of SMZL and HS were positive for IgH gene reconstitution, and exome analysis showed genetic abnormalities in 226 genes including CARD11, suggesting that the SMZL and HS had the same origin.

P2, N=33, Completed, PrECOG, LLC. | Trial completion date: Nov 2024 --> Jul 2024 | Active, not recruiting --> Completed

P2, N=42, Recruiting, Institute of Hematology & Blood Diseases Hospital, China | N=30 --> 42

P3, N=523, Completed, Janssen Research & Development, LLC | Active, not recruiting --> Completed

P2, N=49, Recruiting, Fondazione Italiana Linfomi - ETS | Trial completion date: Feb 2027 --> Apr 2029 | Trial primary completion date: Feb 2025 --> Apr 2026

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

P2, N=37, Active, not recruiting, Fondazione Italiana Linfomi - ETS | Trial completion date: Aug 2024 --> Dec 2024 | Trial primary completion date: Aug 2024 --> Dec 2024

P2, N=55, Not yet recruiting, Massachusetts General Hospital

Here, we demonstrated the antileukemia activity of a novel small molecular compound NL101, which is formed through the modification on bendamustine with a suberanilohydroxamic acid (SAHA) radical. The inhibition of mammalian target of rapamycin (mTOR) by rapamycin enhanced the sensitivity of AML cells to NL101-induced cell death. These findings uncover PTEN protein expression as a major determinant of chemosensitivity to NL101 and provide a novel strategy to treat AML with the combination of NL101 and rapamycin.

P2, N=24, Not yet recruiting, Fox Chase Cancer Center

P2, N=36, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University

P=N/A, N=100, Recruiting, Uppsala University | Not yet recruiting --> Recruiting | Initiation date: Feb 2024 --> Aug 2024

P1, N=64, Recruiting, Fate Therapeutics | N=32 --> 64