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| ID | Type | Description | Link |
|---|---|---|---|
| GO01294 | Other Identifier | Hoffmann-La Roche | |
| 2011-002330-39 | EudraCT Number |
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This is a Phase I, multicenter, open-label, dose-escalation study of polatuzumab vedotin administered as a single agent by intravenous (IV) infusion to participants with relapsed or refractory hematologic malignancies. In Phase Ib, participants will receive polatuzumab vedotin in combination with rituximab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polatuzumab Vedotin | Experimental | Polatuzumab vedotin will be administered by an IV infusion of escalating doses (starting dose of 0.1 mg/kg, potentially to be followed by 0.25 mg/kg, 0.5 mg/kg, 1.0 mg/kg, 2.0 mg/kg, and 4.0 mg/kg doses) every 3 weeks (q3w) (Day 1 of each 21 day cycle). |
|
| Polatuzumab Vedotin + Rituximab | Experimental | Polatuzumab vedotin will be administered by an IV infusion q3w (Day 1 of each 21 day cycle). Rituximab was administered by an IV infusion at 375 milligrams per square meter (mg/m^2) body surface area dose q3w. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polatuzumab Vedotin | Drug | Participants will receive escalating intravenous dose of polatuzumab vedotin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Dose-Limiting Toxicities (DLTs) | Cycle 1 (Days 1-21) | |
| Maximum Tolerated Dose | Cycle 1 (Days 1-21) | |
| Proposed Phase II Dose of Polatuzumab Vedotin | Cycle 1 (Days 1-21) | |
| Percentage of Participants With Adverse Events (AEs) | Baseline up to 646 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Paticipants with Anti Therapeutic Antibodies (ATAs) Against Polatuzumab Vedotin | Preinfusion (0 hour) on Day 1 of Cycles 1, 2, 4, and at the treatment completion/early termination visit (up to 646 days) | |
| Progression Free Survival (PFS), as Assessed by Using Modified Response Criteria for Non-Hodgkin Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yu-Waye Chu, M.D. | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Center | Stanford | California | 94305-5820 | United States | ||
| Stanford Cancer Institute Pharmacy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32770353 | Derived | 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. | |
| 32705923 |
| Label | URL |
|---|---|
| Link to the publication | View source |
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|
| Rituximab | Drug | Rituximab will be administered by an IV infusion at 375 mg/m^2 body surface area dose q3w. |
|
| Baseline up to disease progression or death (Every 3 months while on study treatment from the initiation of therapy and 30 days after last dose of study drug [up to 44.5 months]) |
| Percentage of Participants With Objective Response [Complete Response (CR) or Partial Response (PR)], as Assessed by Using Modified Response Criteria for NHL or CLL | Every 3 months while on study treatment from the initiation of therapy and 30 days after last dose of study drug (up to 44.5 months) |
| Duration of Response, as Assessed by Using Modified Response Criteria for NHL or CLL | Baseline up to disease progression or death (Every 3 months while on study treatment from the initiation of therapy and 30 days after last dose of study drug [up to 44.5 months]) |
| Percentage of Participants with Best Overall Response (BOR), as Assessed by Using Modified Response Criteria for NHL or CLL | Baseline up to disease progression or death (Every 3 months while on study treatment from the initiation of therapy and 30 days after last dose of study drug [up to 44.5 months]) |
| Area Under the Curve (AUC) from Time 0 to The Last Quantifiable Time Point (AUClast)-Polatuzumab Vedotin Monotherapy | Pre infusion (0 hour) and 0.5, 4 hours post infusion (duration of infusion: 90 minutes for first infusion and 30 minutes for subsequent infusions) on Cycle 1 Day 1; Cycle 1 Days 2, 4, 8, 11 and 15 (cycle length: 21 days) |
| AUC Extrapolating to Time of Infinity (AUCinf)-Polatuzumab Vedotin Monotherapy | Pre infusion (0 hour) and 0.5, 4 hours post infusion (duration of infusion: 90 minutes for first infusion and 30 minutes for subsequent infusions) on Cycle 1 Day 1; Cycle 1 Days 2, 4, 8, 11 and 15 (cycle length: 21 days) |
| Percentage of AUCinf (AUCextrap)-Polatuzumab Vedotin Monotherapy | Pre infusion (0 hour) and 0.5, 4 hours post infusion (duration of infusion: 90 minutes for first infusion and 30 minutes for subsequent infusions) on Cycle 1 Day 1; Cycle 1 Days 2, 4, 8, 11 and 15 (cycle length: 21 days) |
| Maximum Plasma Concentration (Cmax)-Polatuzumab Vedotin Monotherapy | Pre infusion (0 hour) and 0.5, 4 hours post infusion (duration of infusion: 90 minutes for first infusion and 30 minutes for subsequent infusions) on Cycle 1 Day 1; Cycle 1 Days 2, 4, 8, 11 and 15 (cycle length: 21 days) |
| Clearance-Polatuzumab Vedotin Monotherapy | Pre infusion (0 hour) and 0.5, 4 hours post infusion (duration of infusion: 90 minutes for first infusion and 30 minutes for subsequent infusions) on Cycle 1 Day 1; Cycle 1 Days 2, 4, 8, 11 and 15 (cycle length: 21 days) |
| Volume of Distribution at Steady State-Polatuzumab Vedotin Monotherapy | Pre infusion (0 hour) and 0.5, 4 hours post infusion (duration of infusion: 90 minutes for first infusion and 30 minutes for subsequent infusions) on Cycle 1 Day 1; Cycle 1 Days 2, 4, 8, 11 and 15 (cycle length: 21 days) |
| AUClast - Polatuzumab Vedotin Combined with Rituximab | Pre infusion (0 hour) and 0.5 hours post infusion (duration of infusion: 90 minutes for first infusion and 30 minutes for subsequent infusions) on Cycle 1 Day 1; Cycle 1 Days 2, 4, 8, 11 and 15 (cycle length: 21 days) |
| AUCinf-Polatuzumab Vedotin Combined with Rituximab | Pre infusion (0 hour) and 0.5 hours post infusion (duration of infusion: 90 minutes for first infusion and 30 minutes for subsequent infusions) on Cycle 1 Day 1; Cycle 1 Days 2, 4, 8, 11 and 15 (cycle length: 21 days) |
| AUCextrap-Polatuzumab Vedotin Combined with Rituximab | Pre infusion (0 hour) and 0.5 hours post infusion (duration of infusion: 90 minutes for first infusion and 30 minutes for subsequent infusions) on Cycle 1 Day 1; Cycle 1 Days 2, 4, 8, 11 and 15 (cycle length: 21 days) |
| Cmax-Polatuzumab Vedotin Combined with Rituximab | Pre infusion (0 hour) and 0.5 hours post infusion (duration of infusion: 90 minutes for first infusion and 30 minutes for subsequent infusions) on Cycle 1 Day 1; Cycle 1 Days 2, 4, 8, 11 and 15 (cycle length: 21 days) |
| Clearance-Polatuzumab Vedotin Combined with Rituximab | Pre infusion (0 hour) and 0.5 hours post infusion (duration of infusion: 90 minutes for first infusion and 30 minutes for subsequent infusions) on Cycle 1 Day 1; Cycle 1 Days 2, 4, 8, 11 and 15 (cycle length: 21 days) |
| Volume of Distribution at Steady State-Polatuzumab Vedotin Combined with Rituximab | Pre infusion (0 hour) and 0.5 hours post infusion (duration of infusion: 90 minutes for first infusion and 30 minutes for subsequent infusions) on Cycle 1 Day 1; Cycle 1 Days 2, 4, 8, 11 and 15 (cycle length: 21 days) |
| AUClast of Rituximab When Given in Combination With Polatuzumab Vedotin | Pre rituximab (0 hour) dose and 30 minutes post rituximab dose on Cycle 1 Day 1; Cycle 1 Days 4, 8, 15 (cycle length: 21 days) |
| AUCinf of Rituximab When Given in Combination With Polatuzumab Vedotin | Pre rituximab (0 hour) dose and 30 minutes post rituximab dose on Cycle 1 Day 1; Cycle 1 Days 4, 8, 15 (cycle length: 21 days) |
| AUCextrap of Rituximab When Given in Combination With Polatuzumab Vedotin | Pre rituximab (0 hour) dose and 30 minutes post rituximab dose on Cycle 1 Day 1; Cycle 1 Days 4, 8, 15 (cycle length: 21 days) |
| Cmax of Rituximab When Given in Combination With Polatuzumab Vedotin | Pre rituximab (0 hour) dose and 30 minutes post rituximab dose on Cycle 1 Day 1; Cycle 1 Days 4, 8, 15 (cycle length: 21 days) |
| Clearance of Rituximab When Given in Combination With Polatuzumab Vedotin | Pre rituximab (0 hour) dose and 30 minutes post rituximab dose on Cycle 1 Day 1; Cycle 1 Days 4, 8, 15 (cycle length: 21 days) |
| Volume of Distribution at Steady State-of Rituximab When Given in Combination With Polatuzumab Vedotin | Pre rituximab (0 hour) dose and 30 minutes post rituximab dose on Cycle 1 Day 1; Cycle 1 Days 4, 8, 15 (cycle length: 21 days) |
| Stanford |
| California |
| 94305 |
| United States |
| Florida Cancer Specialists; Sarasota | Sarasota | Florida | 34232 | United States |
| Roswell Park Cancer Inst. | Buffalo | New York | 14263 | United States |
| Sarah Cannon Cancer Center | Germantown | Tennessee | 38138 | United States |
| M.D Anderson Cancer Center; Oncology | Houston | Texas | 77030 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| Cross Cancer Institute ; Dept of Medical Oncology | Edmonton | Alberta | T6G 1Z2 | Canada |
| British Columbia Cancer Agency | Vancouver | British Columbia | V5Z 1H6 | Canada |
| McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology | Montreal | Quebec | H3T 1E2 | Canada |
| CHU Dijon - SCE Hemato | Dijon | 21000 | France |
| Centre Hospitalier Regional Universitaire de Lille | Lille | France |
| CHU Lapeyronie, Hematologie | Montpellier | 34295 | France |
| Centre Hospitalier Lyon Sud; Hematolgie | Pierre-Bénite | 69495 | France |
| Centre Henri Becquerel; Hematologie | Rouen | 76038 | France |
| Academisch Medisch Centrum; Hematologie | Amsterdam | 1105 AZ | Netherlands |
| Derived |
| 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. |
| 25925619 | Derived | Palanca-Wessels MC, Czuczman M, Salles G, Assouline S, Sehn LH, Flinn I, Patel MR, Sangha R, Hagenbeek A, Advani R, Tilly H, Casasnovas O, Press OW, Yalamanchili S, Kahn R, Dere RC, Lu D, Jones S, Jones C, Chu YW, Morschhauser F. Safety and activity of the anti-CD79B antibody-drug conjugate polatuzumab vedotin in relapsed or refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukaemia: a phase 1 study. Lancet Oncol. 2015 Jun;16(6):704-15. doi: 10.1016/S1470-2045(15)70128-2. Epub 2015 Apr 27. |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000600736 | polatuzumab vedotin |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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