- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Rituxan (rituximab) / Roche, Imbruvica (ibrutinib) / AbbVie, J&J
Trial completion date, Trial primary completion date: Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib and Rituximab) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma (clinicaltrials.gov) - Apr 8, 2024 P2, N=92, Recruiting, Trial completion date: Apr 2024 --> Mar 2028 | Trial primary completion date: Apr 2024 --> Mar 2028
- |||||||||| Zolinza (vorinostat) / Merck (MSD), Rituxan (rituximab) / Roche
Trial completion date, Combination therapy, Metastases: Vorinostat, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - Apr 4, 2024 P1/2, N=83, Active, not recruiting,
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Opdivo (nivolumab) / Ono Pharma, BMS, Rituxan (rituximab) / Roche
Enrollment change, Trial withdrawal: NCI-2023-08755: Venetoclax, Rituximab and Nivolumab in Combination for the Treatment of Richter's Transformation Arising From Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (clinicaltrials.gov) - Mar 2, 2024 P2, N=0, Withdrawn, Trial completion date: Jan 2024 --> Jan 2025 N=29 --> 0 | Not yet recruiting --> Withdrawn
- |||||||||| Rituxan (rituximab) / Roche, Imbruvica (ibrutinib) / AbbVie, J&J
Trial completion date, Trial primary completion date: Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas (clinicaltrials.gov) - Nov 12, 2023 P1, N=54, Recruiting, 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 Trial completion date: Sep 2023 --> Jun 2025 | Trial primary completion date: Sep 2023 --> Jun 2025
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche, Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date, Combination therapy: NCI-2017-01957: Testing the Addition of an Immunotherapy Agent, Atezolizumab, When Given With the Usual Chemo-Immunotherapy Drug Combination (Rituximab Plus Gemcitabine and Oxaliplatin) for Relapsed/Refractory (That Has Come Back or Not Responded to Treatment) Transformed Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - Jul 28, 2023 P1, N=24, Active, not recruiting, Trial completion date: Sep 2023 --> Jun 2025 | Trial primary completion date: Sep 2023 --> Jun 2025 Trial completion date: Jun 2023 --> Jan 2024 | Trial primary completion date: Jun 2023 --> Jan 2024
- |||||||||| Polivy (polatuzumab vedotin-piiq) / Roche, parsaclisib (INCB50465) / Incyte, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Enrollment closed: Parsaclisib With or Without Polatuzumab Vedotin Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma (clinicaltrials.gov) - May 18, 2023 P1, N=50, Active, not recruiting, Trial completion date: Jul 2023 --> Dec 2023 | Trial primary completion date: Jul 2023 --> Dec 2023 Recruiting --> Active, not recruiting
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Rituxan (rituximab) / Roche, Imbruvica (ibrutinib) / AbbVie, J&J
Trial completion date, Trial primary completion date: Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib and Rituximab) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma (clinicaltrials.gov) - May 3, 2023 P2, N=71, Suspended, Recruiting --> Active, not recruiting Trial completion date: Apr 2023 --> Apr 2024 | Trial primary completion date: Apr 2023 --> Apr 2024
- |||||||||| Rituxan (rituximab) / Roche, Imbruvica (ibrutinib) / AbbVie, J&J
Trial completion date, IO biomarker: ECOG-ACRIN E1912: Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov) - Mar 21, 2023 P3, N=529, Active, not recruiting, Suspended --> Recruiting Trial completion date: Jun 2026 --> Mar 2024
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche, Tecentriq (atezolizumab) / Roche
Enrollment closed, Combination therapy: NCI-2017-01957: Testing the Addition of an Immunotherapy Agent, Atezolizumab, When Given With the Usual Chemo-Immunotherapy Drug Combination (Rituximab Plus Gemcitabine and Oxaliplatin) for Relapsed/Refractory (That Has Come Back or Not Responded to Treatment) Transformed Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - Oct 18, 2022 P1, N=24, Active, not recruiting, Conclusion s : Rituximab biosimilar based chemotherapy was effective and safe in real-world clinical practice as the first-line treatment for B-cell NHL and CLL. Suspended --> Active, not recruiting
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche, Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date, Combination therapy: NCI-2017-01957: Testing the Addition of an Immunotherapy Agent, Atezolizumab, When Given With the Usual Chemo-Immunotherapy Drug Combination (Rituximab Plus Gemcitabine and Oxaliplatin) for Relapsed/Refractory (That Has Come Back or Not Responded to Treatment) Transformed Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - Jul 5, 2022 P1, N=24, Suspended, Recruiting --> Suspended Trial completion date: Jun 2022 --> Jun 2023 | Trial primary completion date: Jun 2022 --> Jun 2023
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche, Tecentriq (atezolizumab) / Roche
Trial suspension, Combination therapy: NCI-2017-01957: Testing the Addition of an Immunotherapy Agent, Atezolizumab, When Given With the Usual Chemo-Immunotherapy Drug Combination (Rituximab Plus Gemcitabine and Oxaliplatin) for Relapsed/Refractory (That Has Come Back or Not Responded to Treatment) Transformed Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - Jun 16, 2022 P1, N=24, Suspended, Trial completion date: Jun 2022 --> Jun 2023 | Trial primary completion date: Jun 2022 --> Jun 2023 Recruiting --> Suspended
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical, Review, Journal: Regulatory Approval Scenario of Biosimilars in Pediatric Patients in the United States and European Union. (Pubmed Central) - Oct 30, 2021 In the EU, pediatric assessments were not required for biosimilars; hence, all biosimilars (except rituximab) have been approved for the same indications as those of the reference biologics. Biosimilar developers need to be aware of the possible requirement of a pediatric study plan, development of pediatric drug delivery devices, and requirement of human factor studies for a device, to avoid delay in approval of biosimilars in the USA.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Rituxan (rituximab) / Roche, Imbruvica (ibrutinib) / AbbVie, J&J
Enrollment open: Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib and Rituximab) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma (clinicaltrials.gov) - Oct 24, 2021 P2, N=71, Recruiting, Biosimilar developers need to be aware of the possible requirement of a pediatric study plan, development of pediatric drug delivery devices, and requirement of human factor studies for a device, to avoid delay in approval of biosimilars in the USA. Suspended --> Recruiting
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche, Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date, Combination therapy: NCI-2017-01957: Testing the Addition of an Immunotherapy Agent, Atezolizumab, When Given With the Usual Chemo-Immunotherapy Drug Combination (Rituximab Plus Gemcitabine and Oxaliplatin) for Relapsed/Refractory (That Has Come Back or Not Responded to Treatment) Transformed Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - Jul 6, 2021 P1, N=24, Recruiting, Not yet recruiting --> Suspended Trial completion date: Jun 2021 --> Jun 2022 | Trial primary completion date: Jun 2021 --> Jun 2022
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