Erudio Healtherudio.com
Clinical trial · no report yet · Phase 1/Phase 2
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
- NCT02257567 ↗
- Completed
- Hoffmann-La Roche
- Standard
We haven't built an HCP commentary report on GO29365 (polatuzumab vedotin; polatuzumab vedotin plus obinutuzumab plus bendamustine in relapsed/refractory follicular or diffuse large B-cell lymphoma) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on GO29365 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 11 | |
| YouTube | 1 | |
| Podcasts | 1 |
The trial
ClinicalTrials.gov- Official title
- A Phase IB/II Study Evaluating The Safety, Tolerability and Anti-Tumor Activity of Polatuzumab Vedotin in Combination With Rituximab (R) or Obinutuzumab (G) Plus Bendamustine (B) in Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma
- Phase
- Phase 1/Phase 2
- Status
- Completed
- Conditions
- Lymphoma
- Interventions
- Bendamustine; Obinutuzumab; Polatuzumab vedotin (Liquid); Rituximab; Polatuzumab vedotin (Lyophilized)
- Arms
- Arm A (Phase II Randomization): Polatuzumab+BR in FL · Experimental
- Arm B (Phase II Randomization): BR in FL · Active comparator
- Arm C (Phase II Randomization): Polatuzumab+BR in DLBCL · Experimental
- Arm D (Phase II Randomization): BR in DLBCL · Active comparator
- Arm E (Phase II Expansion): Polatuzumab+BG in FL · Experimental
- Arm F (Phase II Expansion): Polatuzumab+BG in DLBCL · Experimental
- Cohort 1A (Phase Ib Safety Run-In): Polatuzumab+BR in DLBCL · Experimental
- Cohort 1A (Phase Ib Safety Run-In): Polatuzumab+BR in FL · Experimental
- Cohort 1B (Phase Ib Safety Run-In): Polatuzumab+BG in DLBCL · Experimental
- Cohort 1B (Phase Ib Safety Run-In): Polatuzumab+BG in FL · Experimental
- Arm G (Phase II NF Cohort): Polatuzumab+BR in DLBCL · Experimental
- Arm H (Phase II NF Cohort): Polatuzumab+BR in DLBCL · Experimental
- Enrollment
- 331
- Primary outcomes
- Phase Ib: Percentage of Participants With Adverse Events (AEs)
- Arm G+H (Phase II NF Cohort): Percentage of Participants With AEs
- Cohort 1a (Phase Ib): Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) to Polatuzumab Vedotin
- Cohort 1b (Phase Ib): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin and Obinutuzumab
- Arms G+H: (Phase II NF Cohorts): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin (Lyophilized)
- Phase II Randomized and NF Cohorts: Percentage of Participants With Complete Response (CR) at Primary Response Assessment (PRA) Based on Positron Emission Tomography (PET)-Computed Tomography (CT) Scan as Determined by Independent Review Committee (IRC)
- Arm H (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on PET-CT as Determined by the IRC
- Arm G (Phase II NF Cohort): Area Under Concentration-Time Curve (AUC) of Polatuzumab Vedotin (Lyophilized)
- Arm G (Phase II NF Cohort): Maximum Concentration (Cmax) of Polatuzumab Vedotin (Lyophilized)
- Arm G (Phase II NF Cohort): Systemic Clearance (CL) of Polatuzumab Vedotin (Lyophilized)
- Arm G (Phase II NF Cohort): Steady-State Volume of Distribution (Vss) of Polatuzumab Vedotin (Lyophilized)
- Sponsor
- Hoffmann-La Roche
- Start
- Oct 15, 2014
- Primary completion
- Oct 21, 2021
- Results posted
- Yes
- Registry record
- NCT02257567 · updated Nov 14, 2022
Publications
linked from the registry- Jemaa S, Ounadjela S, Wang X, El-Galaly TC, Kostakoglu L, Knapp A, Ku G, Musick L, Sahin D, Wei MC, Yin S, Bengtsson T, De Crespigny A, Carano RAD. Automated Lugano Metabolic Response Assessment in 18F-Fluorodeoxyglucose-Avid Non-Hodgkin Lymphoma With Deep Learning on 18F-Fluorodeoxyglucose-Positron Emission Tomography. J Clin Oncol. 2024 Sep 1;42(25):2966-2977. doi: 10.1200/JCO.23.01978. Epub 2024 Jun 6. PubMed 38843483
- Bosch F, Kuruvilla J, Vassilakopoulos TP, Maio DD, Wei MC, Zumofen MB, Nastoupil LJ. Indirect Treatment Comparisons of Mosunetuzumab With Third- and Later-Line Treatments for Relapsed/Refractory Follicular Lymphoma. Clin Lymphoma Myeloma Leuk. 2024 Feb;24(2):105-121. doi: 10.1016/j.clml.2023.09.007. Epub 2023 Sep 28. PubMed 37981564
- Herrera AF, Tracy S, Croft B, Opat S, Ray J, Lovejoy AF, Musick L, Paulson JN, Sehn LH, Jiang Y. Risk profiling of patients with relapsed/refractory diffuse large B-cell lymphoma by measuring circulating tumor DNA. Blood Adv. 2022 Mar 22;6(6):1651-1660. doi: 10.1182/bloodadvances.2021006415. PubMed 35086141
- Sehn LH, Hertzberg M, Opat S, Herrera AF, Assouline S, Flowers CR, Kim TM, McMillan A, Ozcan M, Safar V, Salles G, Ku G, Hirata J, Chang YM, Musick L, Matasar MJ. Polatuzumab vedotin plus bendamustine and rituximab in relapsed/refractory DLBCL: survival update and new extension cohort data. Blood Adv. 2022 Jan 25;6(2):533-543. doi: 10.1182/bloodadvances.2021005794. PubMed 34749395
- Betts KA, Thuresson PO, Felizzi F, Du EX, Dieye I, Li J, Schulz M, Masaquel AS. US cost-effectiveness of polatuzumab vedotin, bendamustine and rituximab in diffuse large B-cell lymphoma. J Comp Eff Res. 2020 Oct;9(14):1003-1015. doi: 10.2217/cer-2020-0057. Epub 2020 Oct 8. PubMed 33028076
- Shi R, Lu T, Ku G, Ding H, Saito T, Gibiansky L, Agarwal P, Li X, Jin JY, Girish S, Miles D, Li C, Lu D. Asian race and origin have no clinically meaningful effects on polatuzumab vedotin pharmacokinetics in patients with relapsed/refractory B-cell non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2020 Sep;86(3):347-359. doi: 10.1007/s00280-020-04119-8. Epub 2020 Aug 8. PubMed 32770353
- Lu T, Gibiansky L, Li X, Li C, Shi R, Agarwal P, Hirata J, Miles D, Chanu P, Girish S, Jin JY, Lu D. Exposure-safety and exposure-efficacy analyses of polatuzumab vedotin in patients with relapsed or refractory diffuse large B-cell lymphoma. Leuk Lymphoma. 2020 Dec;61(12):2905-2914. doi: 10.1080/10428194.2020.1795154. Epub 2020 Jul 24. PubMed 32705923
- Sehn LH, Herrera AF, Flowers CR, Kamdar MK, McMillan A, Hertzberg M, Assouline S, Kim TM, Kim WS, Ozcan M, Hirata J, Penuel E, Paulson JN, Cheng J, Ku G, Matasar MJ. Polatuzumab Vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2020 Jan 10;38(2):155-165. doi: 10.1200/JCO.19.00172. Epub 2019 Nov 6. PubMed 31693429