- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial suspension, Combination therapy: PrE0403: Phase II Venetoclax, Obinutuzumab and Bendamustine in High Tumor Burden Follicular Lymphoma as Front Line Therapy (clinicaltrials.gov) - Sep 27, 2018
P2, N=56, Suspended,
Recruiting --> Suspended
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Tecentriq (atezolizumab) / Roche
Trial primary completion date, Combination therapy: BO29562: A Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Obinutuzumab Plus Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma (clinicaltrials.gov) - Sep 24, 2018
P1/2, N=38, Active, not recruiting,
Recruiting --> Active, not recruiting Trial primary completion date: Nov 2020 --> Oct 2018
- |||||||||| idasanutlin (RG7388) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Enrollment closed, Enrollment change, Combination therapy: A Study of Idasanutlin in Combination With Obinutuzumab in Relapsed/Refractory (R/R) Follicular Lymphoma (FL) and in Combination With Rituximab in R/R Diffuse Large B-Cell Lymphoma (DLBCL) Participants (clinicaltrials.gov) - Sep 18, 2018
P1/2, N=25, Active, not recruiting,
Trial primary completion date: Nov 2020 --> Oct 2018 Recruiting --> Active, not recruiting | N=120 --> 25
- |||||||||| idasanutlin (RG7388) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Trial completion date, Trial primary completion date, Combination therapy: A Study of Idasanutlin in Combination With Obinutuzumab in Relapsed/Refractory (R/R) Follicular Lymphoma (FL) and in Combination With Rituximab in R/R Diffuse Large B-Cell Lymphoma (DLBCL) Participants (clinicaltrials.gov) - Aug 20, 2018
P1/2, N=120, Recruiting,
Trial completion date: Jun 2023 --> Oct 2022 | Trial primary completion date: Jun 2023 --> Oct 2022 Trial completion date: May 2022 --> Feb 2021 | Trial primary completion date: May 2022 --> Feb 2021
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Enrollment open: Acalabrutinib, Venetoclax, and Obinutuzumab for Initial Therapy of CLL (clinicaltrials.gov) - Aug 15, 2018
P2, N=37, Recruiting,
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion date, Trial primary completion date, Combination therapy: A Study of Venetoclax in Combination With Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (clinicaltrials.gov) - Aug 14, 2018
P1, N=82, Active, not recruiting,
Not yet recruiting --> Recruiting Trial completion date: Apr 2018 --> Dec 2018 | Trial primary completion date: Apr 2018 --> Dec 2018
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial primary completion date, Combination therapy: Combination of PCI-32765 With Obinutuzumab in Untreated Follicular Lymphoma (clinicaltrials.gov) - Aug 14, 2018
P2, N=98, Active, not recruiting,
Trial completion date: Apr 2018 --> Dec 2018 | Trial primary completion date: Apr 2018 --> Dec 2018 Trial primary completion date: Jun 2018 --> Apr 2022
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Enrollment closed, Enrollment change, Trial primary completion date: CLLR3: Bendamustine + GA101 (BG) in Relapsed or Refractory CLL Followed by GA101 Maintenance for Responding Patients (clinicaltrials.gov) - Aug 13, 2018
P2, N=27, Active, not recruiting,
Trial primary completion date: Jun 2018 --> Apr 2022 Recruiting --> Active, not recruiting | N=60 --> 27 | Trial primary completion date: Sep 2021 --> Dec 2017
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Roche, Tecentriq (atezolizumab) / Roche
Phase classification, Combination therapy: A Study of Atezolizumab in Combination With Either Obinutuzumab Plus Bendamustine or Obinutuzumab Plus (+) Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Participants With Follicular Lymphoma (FL) or Rituximab + CHOP in Participants With Diffuse Large B-Cell Lymphoma (DLBCL) (clinicaltrials.gov) - Aug 1, 2018
P1/2, N=91, Active, not recruiting,
Recruiting --> Active, not recruiting | N=60 --> 27 | Trial primary completion date: Sep 2021 --> Dec 2017 Phase classification: P1 --> P1/2
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical, Journal, IO biomarker: Predictive value of the CLL-IPI in CLL patients receiving chemo-immunotherapy as first-line treatment. (Pubmed Central) - Jul 27, 2018
CLL-IPI provides the means to stratify CLL patients in the daily clinical practice (Supplementary Table 1). Although validated for OS and time to first treatment (TTFT), the predictive value of CLL-IPI on progression-free survival (PFS) has until now only been demonstrated in a single study on patients treated with chlorambucil (CLB), as monotherapy, or in combination with obinutuzumab or rituximab, as a first-line approach (CLL11 study), and presented as a poster at the annual meeting of the American Society of Hematology (ASH) in 2016.
- |||||||||| Journal, HEOR: Potential cost savings by dose down-rounding of monoclonal antibodies in a community cancer center. (Pubmed Central) - Jul 22, 2018
Trastuzumab, ofatumumab, and obinutuzumab did not require dose-rounding; thus, they were excluded from the analyses...Vial sizes of pembrolizumab and ipilimumab did not allow for a meaningful dose down-rounding...Drug waste can be avoided by convenient vial sizes or can even be eliminated by lyophilized forms like in trastuzumab. Our data reflect the monoclonal antibody use and potential cost savings with the proposed dose down-rounding approach in a community-based cancer program.
- |||||||||| Velexbru (tirabrutinib) / Ono Pharma, Gilead
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy: Dose Escalation and Dose Expansion Study of Tirabrutinib in Combination With Other Targeted Anti-cancer Therapies in Adults With B-cell Malignancies (clinicaltrials.gov) - Jul 19, 2018
P1b, N=197, Active, not recruiting,
Our data reflect the monoclonal antibody use and potential cost savings with the proposed dose down-rounding approach in a community-based cancer program. Recruiting --> Active, not recruiting | N=368 --> 197 | Trial completion date: Sep 2022 --> May 2022 | Trial primary completion date: Mar 2019 --> Nov 2018
- |||||||||| avadomide (CC-122) / BMS
Trial completion date, Trial primary completion date, Combination therapy: ENHANCE: A Phase 1/2, Open-label, Dose Finding Study to Evaluate CC-122 in Combination With Ibrutinib and Obinutuzumab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (clinicaltrials.gov) - Jul 12, 2018
P1/2, N=152, Recruiting,
Because they are based on a humanized mAb they have the potential for direct clinical translation and could improve patient selection for targeted therapy, dosimetry prior to radioimmunotherapy (RIT), and prediction of response to therapy. Trial completion date: Jul 2024 --> Jul 2020 | Trial primary completion date: Jul 2024 --> Jul 2020
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
New P2 trial: Acalabrutinib, Venetoclax, and Obinutuzumab for Initial Therapy of CLL (clinicaltrials.gov) - Jul 10, 2018
P2, N=37, Not yet recruiting,
- |||||||||| Actemra IV (tocilizumab) / Roche, JW Pharma, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Enrollment closed, Enrollment change, Combination therapy: A Study Evaluating the Safety of Tocilizumab in Addition to Standard of Care Premedication Given Before Obinutuzumab + Chlorambucil in Participants With Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL) and Comorbidities (clinicaltrials.gov) - Jul 6, 2018
P1, N=38, Active, not recruiting,
Trial completion date: Dec 2020 --> Dec 2019 Recruiting --> Active, not recruiting | N=60 --> 38
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date, Combination therapy: BO29562: A Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Obinutuzumab Plus Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma (clinicaltrials.gov) - Jul 6, 2018
P1/2, N=38, Active, not recruiting,
Recruiting --> Active, not recruiting | N=60 --> 38 Trial completion date: Mar 2021 --> Nov 2020 | Trial primary completion date: Mar 2021 --> Nov 2020
- |||||||||| Clinical, Review, Journal: What Is the Role of Chemotherapy in Patients With Chronic Lymphocytic Leukemia? (Pubmed Central) - Jul 5, 2018
For patients with 17p-deletion, ibrutinib is the treatment of choice, with venetoclax in the setting of intolerance or relapse. Challenges include developing strategies to limit the duration of these expensive therapies, and to develop combinations with the potential to cure patients with chronic lymphocytic leukemia.
- |||||||||| Arzerra (ofatumumab) / Novartis, Genmab, Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Review, Journal: Reassessment of Anti-CD20 Therapy in Lymphoid Malignancies: Impact, Limitations, and New Directions. (Pubmed Central) - Jun 27, 2018
Rituximab in particular has been combined safely with conventional chemotherapy and has resulted in improved overall survival in major histologic subtypes of B-cell lymphoma and chronic lymphocytic leukemia...Two of these agents, ofatumumab and obinutuzumab, have been approved for use in certain clinical settings...An additional focus of ongoing research is the use of extended schedules of anti-CD20 monoclonal antibodies, as the optimal duration of therapy remains ill-defined in many histologic subtypes. To maximize the use of these agents, well-validated clinical trial endpoints will need to be carefully considered.
- |||||||||| Polivy (polatuzumab vedotin-piiq) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Enrollment open, Trial completion date, Trial primary completion date, Combination therapy: GO29365: 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 (clinicaltrials.gov) - Jun 25, 2018
P1/2, N=250, Recruiting,
To maximize the use of these agents, well-validated clinical trial endpoints will need to be carefully considered. Active, not recruiting --> Recruiting | Trial completion date: Jun 2019 --> Jul 2021 | Trial primary completion date: Apr 2017 --> May 2018
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie
Trial completion date, Trial initiation date, Combination therapy: A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy (clinicaltrials.gov) - Jun 7, 2018
P3b, N=100, Not yet recruiting,
Active, not recruiting --> Recruiting | Trial completion date: Jun 2019 --> Jul 2021 | Trial primary completion date: Apr 2017 --> May 2018 Trial completion date: Feb 2024 --> Jun 2024 | Initiation date: Mar 2018 --> Jun 2018
- |||||||||| Columvi (glofitamab-gxbm) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Enrollment change, Combination therapy: NP30179: A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (clinicaltrials.gov) - Jun 6, 2018
P1, N=160, Recruiting,
Recruiting --> Active, not recruiting | N=40 --> 3 N=110 --> 160
- |||||||||| cibisatamab (RG7802) / Roche
Enrollment closed, Trial completion date, Trial primary completion date, Tumor cell, Metastases: A Study of RO6958688 in Participants With Locally Advanced and/or Metastatic Carcinoembryonic Antigen Positive Solid Tumors (clinicaltrials.gov) - May 3, 2018
P1, N=185, Active, not recruiting,
Not yet recruiting --> Recruiting | Initiation date: Nov 2017 --> Apr 2018 Recruiting --> Active, not recruiting | Trial completion date: Apr 2018 --> Aug 2019 | Trial primary completion date: Apr 2018 --> Aug 2019
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Enrollment closed, Trial completion date: GIBB: A Study of Obinutuzumab + Bendamustine (BG) in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov) - Apr 27, 2018
P2, N=102, Active, not recruiting,
Recruiting --> Active, not recruiting | Trial completion date: Apr 2018 --> Aug 2019 | Trial primary completion date: Apr 2018 --> Aug 2019 Completed --> Active, not recruiting | Trial completion date: Oct 2017 --> Feb 2019
- |||||||||| Phase classification, Trial completion date, Combination therapy: A Study Evaluating Safety and Efficacy of Obinutuzumab, Polatuzumab Vedotin (Pola), and Atezolizumab (Atezo) in Participants With Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab, Atezo, and Pola in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (clinicaltrials.gov) - Apr 25, 2018
P1/2, N=36, Active, not recruiting,
Active, not recruiting --> Recruiting | N=64 --> 90 Phase classification: P1 --> P1/2 | Trial completion date: Jul 2021 --> Apr 2020
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Roche, Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date, Combination therapy: A Study of Atezolizumab in Combination With Either Obinutuzumab Plus Bendamustine or Obinutuzumab Plus (+) Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Participants With Follicular Lymphoma (FL) or Rituximab + CHOP in Participants With Diffuse Large B-Cell Lymphoma (DLBCL) (clinicaltrials.gov) - Apr 23, 2018
P1, N=91, Active, not recruiting,
Phase classification: P1 --> P1/2 | Trial completion date: Jul 2021 --> Apr 2020 Trial completion date: Sep 2021 --> Mar 2020 | Trial primary completion date: Sep 2021 --> Apr 2018
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