Therapy Detail
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| Therapy Name | Bendamustine + Rituximab |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Bendamustine | Treanda | Ribomustin|SyB L-0501|SDX-105 | Chemotherapy - Alkylating 18 | Treanda (bendamustine) is an alkylating agent with unique mechanisms, resulting in increased DNA damage and base-excision DNA repair pathway induction, and potentially leading to decreased growth of tumors, including those resistant to other alkylating agents (PMID: 18172283, PMID: 19117340, PMID: 19224851). Treanda (bendamustine) is FDA approved for use in chronic lymphocytic leukemia and indolent non-Hodgkin lymphoma (FDA.gov). |
| Rituximab | Rituxan | IDEC-C2B8|MabThera | CD20 Antibody 24 | Rituxan (rituximab) is a chimeric mononclonal antibody that binds to CD20 on B-cells, resulting in induction of complement-dependent and antibody-dependent cytotoxicity, and potentially leading to decreased B-cell tumor growth (PMID: 28983798). Rituxan (rituximab) is FDA approved for use as monotherapy or in combination with chemotherapy in CD20-positive B-cell non-Hodgkin lymphoma, in combination with fludarabine and cyclophosphamide in CD20-positive chronic lymphocytic leukemia, and in combination with chemotherapy in pediatric patients (6 month to 18 years of age) with treatment-naive, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia (B-AL) (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| TP53 loss | mantle cell lymphoma | no benefit | Bendamustine + Rituximab | Case Reports/Case Series | Actionable | In a clinical case study, a patient with non-nodal leukemic mantle cell lymphoma with TP53 loss, as well as a CCND1 translocation, had no response to combined Rituxan (rituximab) and Treanda (bendamustine) therapy, and had a doubling of white blood cells during two cycles of treatment (PMID: 30559058). | 30559058 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02951156 | Phase III | Avelumab + Azacitidine + Utomilumab Avelumab + Rituximab + Utomilumab Bendamustine + Rituximab Gemcitabine + Oxaliplatin + Rituximab Avelumab + Bendamustine + Rituximab | Avelumab In Combination Regimens That Include An Immune Agonist, Epigenetic Modulator, CD20 Antagonist and/or Conventional Chemotherapy in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) | Terminated | USA | POL | ITA | GBR | ESP | BEL | AUS | 1 |
| NCT06425302 | Phase II | Cyclophosphamide + Doxorubicin + Prednisone + Rituximab + Vincristine Sulfate Bendamustine + Rituximab CC-99282 + Rituximab | A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma (GOLSEEK-2) | Recruiting | USA | POL | ITA | GBR | FRA | ESP | DEU | CAN | BRA | AUS | 3 |
| NCT03336333 | Phase III | Venetoclax + Zanubrutinib Zanubrutinib Bendamustine + Rituximab | A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL (SEQUOIA) | Active, not recruiting | USA | SWE | POL | NZL | ITA | GBR | FRA | ESP | CZE | BEL | AUT | AUS | 3 |
| NCT04666038 | Phase III | Idelalisib + Rituximab Pirtobrutinib Bendamustine + Rituximab | Study of LOXO-305 Versus Investigator's Choice (IdelaR or BR) in Patients With CLL or SLL | Active, not recruiting | USA | TUR | POL | ITA | ISR | IRL | HUN | HRV | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BEL | AUT | AUS | 6 |
| NCT06091254 | Phase III | Odronextamab Cyclophosphamide + Prednisone + Rituximab + Vincristine Sulfate Cyclophosphamide + Doxorubicin + Prednisone + Rituximab + Vincristine Sulfate Bendamustine + Rituximab | A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Participants With Follicular Lymphoma (OLYMPIA-1) | Recruiting | USA | TUR | POL | ITA | ISR | GBR | FRA | ESP | DEU | CZE | CHE | CAN | AUT | AUS | 2 |
| NCT05848765 | Phase II | Bendamustine + Obinutuzumab Epcoritamab-bysp + Lenalidomide Cyclophosphamide + Doxorubicin + Prednisone + Rituximab + Vincristine Sulfate Bendamustine + Rituximab Cyclophosphamide + Prednisone + Rituximab + Vincristine Sulfate Lenalidomide + Rituximab | Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy (REFRACT) | Recruiting | GBR | 0 |
| NCT02576275 | Phase III | Bendamustine + Rituximab Duvelisib | A Study of Duvelisib in Combination With Rituximab and Bendamustine vs Placebo in Combination With Rituximab and Bendamustine in Subjects With Previously-Treated Indolent Non-Hodgkin Lymphoma (BRAVURA) | Withdrawn | USA | 0 |
| NCT06006117 | Phase III | Lenalidomide + Rituximab Lenalidomide + Mosunetuzumab-axgb Cyclophosphamide + Doxorubicin + Prednisone + Rituximab + Vincristine Sulfate Bendamustine + Rituximab | Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients With Relapsed or Refractory Marginal Zone Lymphoma | Recruiting | FRA | 0 |
| NCT05023980 | Phase III | Pirtobrutinib Bendamustine + Rituximab | A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (BRUIN CLL-313) | Active, not recruiting | USA | ROU | POL | NZL | ITA | HUN | GBR | FRA | ESP | CZE | BRA | BGR | AUT | AUS | 6 |
| NCT02187861 | Phase II | Bendamustine + Rituximab Bendamustine + Rituximab + Venetoclax Rituximab + Venetoclax | A Study Evaluating the Safety and Efficacy of GDC-0199 (ABT-199) Plus Bendamustine + Rituximab (BR) in Comparison With BR or GDC-0199 Plus Rituximab in Patients With Relapsed and Refractory Follicular Non-Hodgkin's Lymphoma | Completed | USA | ITA | GBR | FRA | DEU | CAN | BEL | AUS | 0 |
| NCT04285567 | Phase III | Obinutuzumab + Venetoclax Bendamustine + Rituximab Cyclophosphamide + Fludarabine + Rituximab | A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation (CRISTALLO) | Active, not recruiting | USA | ITA | FRA | ESP | AUS | 0 |
| NCT03836261 | Phase III | Bendamustine + Rituximab Cyclophosphamide + Fludarabine + Rituximab Acalabrutinib + Venetoclax Acalabrutinib + Obinutuzumab + Venetoclax | Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL (AMPLIFY) | Active, not recruiting | USA | TUR | SWE | SVK | POL | NLD | ITA | ISR | HUN | GBR | FRA | ESP | DNK | DEU | CZE | CAN | BRA | BGR | AUT | AUS | ARG | 6 |
| NCT01732926 | Phase III | Idelalisib Bendamustine + Rituximab | Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas | Terminated | USA | SWE | POL | ITA | ISR | GBR | FRA | ESP | DEU | CZE | CAN | AUS | 3 |
| NCT04002297 | Phase III | Rituximab + Zanubrutinib Bendamustine + Rituximab | Study Comparing Zanubrutinib + Rituximab Versus Bendamustine + Rituximab in Patients With Untreated Mantle Cell Lymphoma | Active, not recruiting | USA | TUR | ROU | POL | NZL | NLD | ITA | IRL | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 6 |
| NCT02972840 | Phase III | Bendamustine + Rituximab Acalabrutinib + Bendamustine + Rituximab | A Study of Bendamustine and Rituximab Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated Mantle Cell Lymphoma | Active, not recruiting | USA | ROU | POL | NZL | ITA | ISR | HUN | GRC | FRA | ESP | DEU | CZE | CAN | BRA | BEL | AUS | ARG | 10 |
| NCT05139017 | Phase II | Bendamustine + Rituximab + VLS-101 Gemcitabine + Oxaliplatin + Rituximab + VLS-101 Bendamustine + Rituximab Gemcitabine + Oxaliplatin + Rituximab | A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003) | Recruiting | USA | TUR | POL | ITA | ISR | GBR | FRA | CAN | 5 |
| NCT03609593 | Phase II | Rituximab Bendamustine + Rituximab Venetoclax | Bendamustine/Rituximab Followed by Venetoclax and Rituximab for Treatment of Chronic Lymphocytic Leukemia | Active, not recruiting | USA | 0 |
| NCT06191744 | Phase III | Epcoritamab-bysp + Lenalidomide + Rituximab Bendamustine + Obinutuzumab Lenalidomide + Rituximab Cyclophosphamide + Doxorubicin + Obinutuzumab + Prednisone + Vincristine Sulfate Cyclophosphamide + Doxorubicin + Prednisone + Rituximab + Vincristine Sulfate Bendamustine + Rituximab | Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma (EPCORE™FL-2) | Recruiting | USA | TUR | SWE | SVK | ROU | POL | NZL | NLD | ITA | ISR | HUN | HRV | GRC | GBR | FRA | ESP | DNK | DEU | CZE | BGR | BEL | AUS | 8 |
| NCT02626455 | Phase III | Vincristine Sulfate Prednisone Aldoxorubicin + Cyclophosphamide + Prednisone + Rituximab + Vincristine Sulfate Copanlisib Bendamustine + Rituximab Rituximab | Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL) (CHRONOS-4) | Terminated | USA | TUR | SVK | ROU | POL | ITA | ISR | IRL | HUN | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BRA | BGR | BEL | AUS | 13 |
| NCT06084936 | Phase III | Obinutuzumab Glofitamab-gxbm Lenalidomide + Rituximab Bendamustine + Rituximab | A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma (GLOBRYTE) | Recruiting | USA | SWE | ITA | GBR | FRA | ESP | CAN | BRA | AUS | 3 |
| NCT01974440 | Phase III | Ibrutinib Bendamustine + Rituximab Cyclophosphamide + Doxorubicin + Prednisone + Vincristine Sulfate | A Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Participants With Previously Treated Indolent Non-Hodgkin Lymphoma | Completed | USA | TUR | SWE | POL | ISR | GBR | FRA | ESP | DEU | BRA | BEL | AUS | ARG | 6 |
| NCT06284122 | Phase III | Bendamustine + Obinutuzumab Cyclophosphamide + Doxorubicin + Prednisone + Rituximab + Vincristine Sulfate Bendamustine + Rituximab Lenalidomide + Mosunetuzumab-axgb Cyclophosphamide + Doxorubicin + Obinutuzumab + Prednisone + Vincristine Sulfate | Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5 (MorningLyte) | Recruiting | FRA | ESP | DEU | BEL | 1 |
| NCT05624554 | Phase III | Bendamustine + Rituximab Cyclophosphamide + Fludarabine + Rituximab ARQ 531 | A Study of Nemtabrutinib vs Chemoimmunotherapy for Participants With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations (MK-1026-008, BELLWAVE-008) | Recruiting | USA | TUR | ROU | POL | LTU | HUN | DNK | BRA | BGR | AUS | 11 |
| NCT06549595 | Phase III | Rituximab + TNB-486 Cyclophosphamide + Prednisone + Rituximab + Vincristine Sulfate Cyclophosphamide + Doxorubicin + Prednisone + Rituximab + Vincristine Sulfate Bendamustine + Rituximab | A Study of AZD0486 Plus Rituximab in Previously Untreated Follicular Lymphoma Patients | Recruiting | TUR | SWE | POL | GBR | FIN | ESP | CAN | BEL | AUS | 5 |
| NCT02257567 | Phase Ib/II | Bendamustine + Rituximab Polatuzumab vedotin-piiq Obinutuzumab | A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma | Completed | USA | TUR | NLD | ITA | HUN | GBR | FRA | ESP | DEU | CZE | CAN | AUS | 1 |
| NCT04628494 | Phase III | Gemcitabine + Oxaliplatin + Rituximab Epcoritamab-bysp Bendamustine + Rituximab | A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in R/R DLBCL (EPCORE DLBCL-1) | Active, not recruiting | USA | TUR | SWE | POL | NOR | NLD | ITA | ISR | HUN | GBR | FRA | FIN | ESP | DNK | DEU | CAN | BEL | AUT | AUS | 6 |
| NCT01216683 | Phase II | Bendamustine + Rituximab Bortezomib Lenalidomide | Bendamustine Hydrochloride and Rituximab With or Without Bortezomib Followed by Rituximab With or Without Lenalidomide in Treating Patients With High-Risk Stage II, Stage III, or Stage IV Follicular Lymphoma | Completed | USA | 0 |
| NCT05371093 | Phase III | axicabtagene ciloleucel Cyclophosphamide + Doxorubicin + Prednisone + Rituximab + Vincristine Sulfate Cyclophosphamide + Fludarabine Bendamustine + Rituximab Lenalidomide + Rituximab | Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma (ZUMA-22) | Recruiting | USA | ITA | GBR | FRA | ESP | DEU | 1 |
| NCT02763319 | Phase II | Bendamustine + Tafasitamab-cxix Bendamustine + Rituximab | A Trial to Evaluate the Efficacy and Safety of MOR208 With Bendamustine (BEN) Versus Rituximab (RTX) With BEN in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) (B-MIND) | Completed | USA | TUR | ROU | POL | NZL | ITA | ISR | HUN | HRV | GBR | FRA | FIN | ESP | DEU | CZE | CAN | AUT | AUS | 5 |
| NCT06205290 | Phase III | Idelalisib + Rituximab Lisocabtagene maraleucel Cyclophosphamide + Fludarabine Bendamustine + Rituximab | A Study to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options in Adult Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, Whose Disease Has Failed Treatment With Both BTKi and BCL2i Therapies | Withdrawn | USA | SWE | NOR | NLD | ITA | GBR | FRA | ESP | DEU | BEL | AUT | 0 |
| NCT01059786 | Phase II | Bendamustine + Rituximab Pentostatin + Rituximab | Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia | Active, not recruiting | USA | 0 |
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