Clinical trial NCT06043674: Phase 2 Study of Glofitamab Monotherapy & With Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab in Richter's Transformation
Official title: A Phase 2 Study of Glofitamab as Monotherapy or in Combination With Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab in Richter's Transformation
Conditions: Chronic Lymphocytic Leukemia
Richter's Transformation
Summary: This research is being done to evaluate Glofitamab by itself or in combination with Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab as possible treatments for Chronic Lymphocytic Leukemia (CLL) that has transformed into Richter's Transformation (RT).
The names of the study drugs involved in this research study are:
* Glofitamab (a T-cell bispecific humanized monoclonal antibody)
* Obinutuzumab (a humanized glycoengineered type II anti-CD20 monoclonal antibody)
* Polatuzumab vedotin (an antibody-drug conjugate)
* Pirtobrutinib (a selective inhibitor of BTK)
* Atezolizumab (a humanized immunoglobulin monoclonal antibody)
* Tocilizumab (a recombinant, humanized, anti-human monoclonal antibody)
Interventions:
description: "2:1" T-cell bispecific humanized monoclonal antibody, administered via intravenous infusion per protocol.
name: Glofitamab
other_name: RO7082859
type: Drug
description: Humanized glycoengineered type II anti-CD20 monoclonal antibody, administered via intravenous infusion per protocol.
name: Obinutuzumab
other_name: RO5072759, GA101, GAZYVA, GAZYVARO
type: Drug
description: Antibody-drug conjugate, administered via intravenous infusion per protocol.
name: Polatuzumab Vedotin
other_name: Polivy
type: Drug
description: Humanized immunoglobulin monoclonal antibody, administered via intravenous infusion per protocol.
name: Atezolizumab
other_name: Tecentriq
type: Drug
description: For the treatment of Cytokine Release Syndrome. Recombinant, humanized, anti-human monoclonal antibody, administered via intravenous infusion per protocol.
name: Tocilizumab
other_name: Actemra
type: Drug
description: Selective inhibitor of BTK, 50 mg or 100 mg tablet, via oral administration per protocol.
name: Pirtobrutinib
other_name: Jaypirca
type: Drug
Study arms:
design_group_description: Study procedures will be conducted as follows:<br/>* Baseline visit with screening procedures, including bone marrow biopsy and Positron Emission Tomography (PET) or Computed Topography (CT) scans.<br/>* PET/CT scans after 4, 8, and 12 cycles of therapy and at 6 and 15 months after end-of-treatment.<br/>* Cycle 1:<br/>  * Day 1, 2, and 7 of 21- day Cycle: Predetermined dose of Obinutuzumab 1x daily.<br/>  * Day 8 and 15 of 21- day Cycle: Predetermined dose of Glofitamab 1x daily. Hospitalization will be required for initial dose and post-dose observation.<br/>* Cycle 2 - 12<br/>  --Day 1 of 21-day Cycle: Predetermined dose of Glofitamab 1x daily. Hospitalization will be required for second dose and post-dose observation<br/>* End of treatment visit.<br/>* Follow up visits: for months 10 - 24, visits will be every 3 months. For months 25 - 60 visits will be every 6 months.<br/>* After completion of a 10-patient safety lead-in cohort, enrollment will open to the other two cohorts.
design_group_title: Monotherapy Cohort: Obinutuzumab and Glofitamab
design_group_type: Active Comparator
design_group_description: Study procedures will be conducted as follows:<br/>* Baseline visit with screening procedures, including bone marrow biopsy and PET/CT scans.<br/>* PET/CT scans after 4, 8, and 12 cycles of therapy and at 6 and 15 months after end-of-treatment.<br/>* Cycle 1:<br/>  * Day 1, 2, and 7 of 21- day Cycle: Predetermined dose of Obinutuzumab 1x daily.<br/>  * Day 8 and 15 of 21- day Cycle: Predetermined dose of Glofitamab 1x daily. Hospitalization will be required for initial dose and post-dose observation.<br/>* Cycle 2 - 7:<br/>  - Day 1 of 21-day Cycle: Predetermined dose of Glofitamab 1x daily. Predetermined dose of Polatuzumab Vedotin 1x daily.<br/>* Cycle 8 - 12<br/>  - Day 1 of 21-day Cycle: Predetermined dose of Glofitamab 1x daily.<br/>* End of treatment visit.<br/>* Follow up visits: for months 10 - 24, visits will be every 3 months. For months 25 - 60 visits will be every 6 months.
design_group_title: Combination A Group: Obinutuzumab, Glofitamab, and Polatuzumab Vedotin
design_group_type: Experimental
design_group_description: Study procedures will be conducted as follows:<br/>* Baseline visit with screening procedures, including bone marrow biopsy and PET/CT scans.<br/>* PET/CT scans after 4, 8, and 12 cycles of therapy and at 6 and 15 months after end-of-treatment.<br/>* Cycle 1:<br/>  * Day 1, 2, and 7 of 21- day Cycle: Predetermined dose of Obinutuzumab 1x daily.<br/>  * Day 8 and 15 of 21- day Cycle: Predetermined dose of Glofitamab 1x daily. Hospitalization will be required for initial dose and post-dose observation.<br/>* Cycle 2 - 12<br/>  - Day 1 of 21-day Cycle: Predetermined dose of Glofitamab 1x daily. Predetermined dose of Pirtobrutinib 1x daily. Days 2-21 of each cycle: Pirtobrutinib will be taken once daily.<br/>* End of treatment visit.<br/>* Follow up visits: for months 10 - 24, visits will be every 3 months. For months 25 - 60 visits will be every 6 months.
design_group_title: Combination B Group: Obinutuzumab, Glofitamab, and Pirtobrutinib
design_group_type: Experimental
design_group_description: Study procedures will be conducted as follows:<br/>* Baseline visit with screening procedures, including bone marrow biopsy and PET/CT scans.<br/>* PET/CT scans after 4, 8, and 12 cycles of therapy and at 6 and 15 months after end-of-treatment.<br/>* Cycle 1:<br/>  * Day 1, 2, and 7 of 21- day Cycle: Predetermined dose of Obinutuzumab 1x daily.<br/>  * Day 8 and 15 of 21- day Cycle: Predetermined dose of Glofitamab 1x daily. Hospitalization will be required for initial dose and post-dose observation.<br/>* Cycle 2 - 12<br/>  - Day 1 of 21-day Cycle: Predetermined dose of Glofitamab 1x daily. Predetermined dose of Atezolizumab 1x daily.<br/>* End of treatment visit.<br/>* Follow up visits: for months 10 - 24, visits will be every 3 months. For months 25 - 60 visits will be every 6 months.
design_group_title: Combination C Group: Obinutuzumab, Glofitamab, and Atezolizumab
design_group_type: Experimental
Sponsor: Dana-Farber Cancer Institute, Inc.
Collaborators: Loxo Oncology, Inc.
Genentech, Inc.
Eli Lilly & Co.
Drug name mappings:
name: 维泊妥珠单抗
lang: CN
name: Polatuzumab Vedotin-Piiq
lang: EN
name: ポラツズマブ ベドチン（遺伝子組換え）
lang: JP
name: 托珠单抗
lang: CN
name: Tocilizumab
lang: EN
name: トシリズマブ（遺伝子組換え）
lang: JP
name: 奥妥珠单抗
lang: CN
name: Obinutuzumab
lang: EN
name: オビヌツズマブ（遺伝子組換え）
lang: JP
name: 匹妥布替尼
lang: CN
name: Pirtobrutinib
lang: EN
name: ピルトブルチニブ
lang: JP
name: 阿替利珠单抗
lang: CN
name: Atezolizumab
lang: EN
name: アテゾリズマブ（遺伝子組換え）
lang: JP
name: 格菲妥单抗
lang: CN
name: Glofitamab
lang: EN
name: グローフィタマブ（遺伝子組換え）
lang: JP