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A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma

Primary Purpose

B-cell Non-Hodgkin Lymphoma

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Mosunetuzumab
Polatuzumab Vedotin
Rituxumab
Cyclophosphamide
Doxorubicin
Vincristine
Prednisone
Tocilizumab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-cell Non-Hodgkin Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria for Phase Ib and Phase II Portions

  • At least one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longest diameter
  • Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
  • Adequate hematologic function

Inclusion Criteria for Phase Ib Portion

Participants must also meet the following criteria for study entry into the Phase Ib portion:

  • Histologically confirmed B-cell NHL according to the World Health Organization (WHO) 2016 classification expected to express the cluster of differentiation-20 (CD20) antigen
  • Relapsed or refractory (R/R) B-cell NHL after at least one prior systemic lymphoma therapy
  • Treatment with at least one prior CD20-directed therapy
  • Group B only: no prior treatment with polatuzumab vedotin

Inclusion Criteria for Phase II Portion

Participants must also meet the following criteria for study entry in the Phase II portion:

  • Previously untreated, histologically confirmed DLBCL according to WHO 2016 classification
  • International Prognostic Index (IPI) score of 2-5

Exclusion Criteria

  • Prior treatment with mosunetuzumab
  • Prior allogenic stem-cell transplant
  • Current Grade >1 peripheral neuropathy
  • Participants with history of confirmed progressive multifocal leukoencephalopathy (PML)
  • Known or suspected chronic active Epstein Barr virus (CAEBV), hepatitis B, hepatitis C (HCV), or Human Immunodeficiency Virus (HIV)
  • Prior solid organ transplantation
  • History of autoimmune disease
  • Current or past history of central nervous system (CNS) lymphoma
  • Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
  • Significant cardiovascular disease or pulmonary disease
  • Clinically significant history of liver disease
  • Recent major surgery within 4 weeks before the start of C1D1, other than superficial lymph node biopsies for diagnosis

Exclusion Criteria for Phase Ib Portion

Participants who also meet any of the following criteria will be excluded from study entry in the Phase Ib portion:

  • Prior treatment with chemotherapy, immunotherapy, and biologic therapy 4 weeks prior to C1D1
  • Prior treatment with radiotherapy within 2 weeks prior to C1D1
  • Adverse events from prior anti-cancer therapy resolved to ≤Grade 1 (with the exception of alopecia and anorexia)
  • Prior treatment with >250 mg/m^2 doxorubicin (or equivalent anthracycline dose)

Exclusion Criteria for Phase II Portion

Participants who also meet any of the following criteria will be excluded from study entry in the Phase II portion:

  • Participants with transformed lymphoma
  • Prior therapy for B-cell NHL

Sites / Locations

  • University of Alabama Birmingham
  • University of California; Moores Cancer Center
  • University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica
  • Banner MD Anderson Cancer Center
  • Georgetown University Medical Center
  • University of Miami Miller School of Medicine
  • University of Kansas Cancer Center
  • Dana-Farber Cancer Institute
  • University of Michigan
  • Mayo Clinic Cancer Center
  • Rhode Island Hospital
  • Vanderbilt University Medical Center
  • The University of Texas MD Anderson Cancer Center
  • Scott and White Hospital; Cancer Center
  • Medical College of Wisconsin, Inc.
  • Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU
  • LKH Steyr
  • Medizinische Universität Wien, Allgemeines Krankenhaus der Stadt Wien
  • Hanusch-Krankenhaus
  • CHU Henri Mondor; Service d'Oncologie Medicale
  • Centre Leon Berard
  • Hôpital Saint-Louis
  • Centre Henri Becquerel- Centre de Lutte Contre le Cancer
  • Gustave Roussy
  • Pusan National University Yangsan Hospital
  • Seoul National University Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Maria Sklodowska-Curie Memorial Cancer Centre
  • Ma?opolskie Centrum Medyczne
  • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
  • Instytut Hematologii i Transfuzjologii; Klinika Zaburze? Hemostazy i Chorób Wewn?trznych
  • Katedra i Klinika Hematologii; Nowotworów Krwi i Transplantacji Szpiku
  • Institut Catala d?Oncologia Hospital Germans Trias i Pujol
  • Clinica Universidad de Navarra
  • Hospital Universitario Virgen Macarena
  • Hospital de la Santa Creu i Sant Pau
  • Hospital San Pedro de Alcantara; Servicio de Hematología
  • Hospital General Universitario Gregorio Marañon
  • Hospital Universitario La Paz
  • Hospital Universitario 12 de Octubre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Experimental

Arm Label

Phase Ib: Mosunetuzumab (M)-CHOP Dose Finding

Phase Ib: M-CHP-Pola Dose-Finding

Phase II: M-CHOP Previously Untreated (1L) DLBCL Safety Cohort

Phase II: M-CHP-Pola 1L DLBCL

Phase II: Rituxumab (R)-CHP-Pola 1L DLBCL

Phase II: M-CHOP 1L DLBCL

Arm Description

Participants will receive M-CHOP up to the phase II recommended dose (RP2D).

Participants will receive M-CHP-Pola up to the RP2D.

Participants with 1L DLBCL will receive mosunetuzumab at the RP2D in combination with CHOP.

Participants with 1L DLBCL will receive M-CHP-Pola at a dose determined in the dose finding stage.

Participants with 1L DLBCL will receive R-CHP-Pola at a dose determined in the dose finding stage.

Participants with 1L DLBCL will receive M-CHOP at a dose determined in the dose finding stage.

Outcomes

Primary Outcome Measures

Percentage of Participants with Adverse Events (AE)
Complete Response (CR) Rate at the Time of Primary Response Assessment Based on Positron Emission Tomography - Computed Tomography (PET-CT) as Assessed According to Lugano 2014 Response Criteria

Secondary Outcome Measures

Maximum Serum Concentration (Cmax) of Mosunetuzumab
Minimum Serum Concentration (Cmin) of Mosunetuzumab
Area Under the Curve (AUC) of Mosunetuzumab
Clearance (CL) of Mosunetuzumab
Volume of Distribution at Steady State (Vss) of Mosunetuzumab
Maximum Plasma Concentration (Cmax) of Polatuzumab Vedotin
Minimum Plasma Concentration (Cmin) of Polatuzumab Vedotin
AUC of Polatuzumab Vedotin
CL of Polatuzumab Vedotin
Vss of Polatuzumab Vedotin
Best Objective Response Rate (ORR), Defined as Complete Response (CR) or Partial Response (PR) at any Time on Study Based on PET-CT and/or CT scan as Assessed According to Lugano 2014 Response Criteria
Duration of Response (DOR)
Anti-Drug Antibodies (ADAs) to Mosunetuzumab
ADAs to Polatuzumab Vedotin
Progression-Free Survival (PFS)
PFS at 1 Year
Event-Free Survival (EFS)
Time to Deterioration in the European Organization for Research and Treatment of Cancer Quality of Life - Core 30 Questionnaire (EORTC QLQ-C30) Physical Functioning and Fatigue
Time to Deterioration in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale

Full Information

First Posted
September 11, 2018
Last Updated
September 29, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT03677141
Brief Title
A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma
Official Title
A Phase Ib/II, Open-Label, Multicenter, Randomized, Controlled Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Patients With B-Cell Non-Hodgkin Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 8, 2019 (Actual)
Primary Completion Date
October 12, 2023 (Anticipated)
Study Completion Date
October 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (M-CHOP) and, subsequently, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) plus polatuzumab vedotin (CHP-pola) in participants with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (NHL), and in previously untreated participants with diffuse large B-cell lymphoma (DLBCL).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Non-Hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase Ib: Mosunetuzumab (M)-CHOP Dose Finding
Arm Type
Experimental
Arm Description
Participants will receive M-CHOP up to the phase II recommended dose (RP2D).
Arm Title
Phase Ib: M-CHP-Pola Dose-Finding
Arm Type
Experimental
Arm Description
Participants will receive M-CHP-Pola up to the RP2D.
Arm Title
Phase II: M-CHOP Previously Untreated (1L) DLBCL Safety Cohort
Arm Type
Experimental
Arm Description
Participants with 1L DLBCL will receive mosunetuzumab at the RP2D in combination with CHOP.
Arm Title
Phase II: M-CHP-Pola 1L DLBCL
Arm Type
Experimental
Arm Description
Participants with 1L DLBCL will receive M-CHP-Pola at a dose determined in the dose finding stage.
Arm Title
Phase II: Rituxumab (R)-CHP-Pola 1L DLBCL
Arm Type
Active Comparator
Arm Description
Participants with 1L DLBCL will receive R-CHP-Pola at a dose determined in the dose finding stage.
Arm Title
Phase II: M-CHOP 1L DLBCL
Arm Type
Experimental
Arm Description
Participants with 1L DLBCL will receive M-CHOP at a dose determined in the dose finding stage.
Intervention Type
Drug
Intervention Name(s)
Mosunetuzumab
Intervention Description
Participants will receive intravenous (IV) mosunetuzumab.
Intervention Type
Drug
Intervention Name(s)
Polatuzumab Vedotin
Intervention Description
Participants will receive polatuzumab vedotin via IV.
Intervention Type
Drug
Intervention Name(s)
Rituxumab
Intervention Description
Participants will receive rituxumab via IV.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Participants will receive cyclophosphamide via IV.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
Participants will receive doxorubicin via IV.
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
Participants will receive vincristine via IV.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Participants will receive oral prednisone.
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Intervention Description
Participants will receive tocilizumab via IV.
Primary Outcome Measure Information:
Title
Percentage of Participants with Adverse Events (AE)
Time Frame
Baseline through approximately 90 days after the last study treatment
Title
Complete Response (CR) Rate at the Time of Primary Response Assessment Based on Positron Emission Tomography - Computed Tomography (PET-CT) as Assessed According to Lugano 2014 Response Criteria
Time Frame
Approximately 6-8 weeks after Cycle 6 (cycle = 21 days), or at early treatment discontinuation
Secondary Outcome Measure Information:
Title
Maximum Serum Concentration (Cmax) of Mosunetuzumab
Time Frame
At pre-defined intervals from Cycle 1, Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Title
Minimum Serum Concentration (Cmin) of Mosunetuzumab
Time Frame
At pre-defined intervals from Cycle 1, Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Title
Area Under the Curve (AUC) of Mosunetuzumab
Time Frame
At pre-defined intervals from Cycle 1, Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Title
Clearance (CL) of Mosunetuzumab
Time Frame
At pre-defined intervals from Cycle 1, Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Title
Volume of Distribution at Steady State (Vss) of Mosunetuzumab
Time Frame
At pre-defined intervals from Cycle 1, Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Title
Maximum Plasma Concentration (Cmax) of Polatuzumab Vedotin
Time Frame
At pre-defined intervals from Cycle 1, Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Title
Minimum Plasma Concentration (Cmin) of Polatuzumab Vedotin
Time Frame
At pre-defined intervals from Cycle 1, Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Title
AUC of Polatuzumab Vedotin
Time Frame
At pre-defined intervals from Cycle 1, Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Title
CL of Polatuzumab Vedotin
Time Frame
At pre-defined intervals from Cycle 1, Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Title
Vss of Polatuzumab Vedotin
Time Frame
At pre-defined intervals from Cycle 1, Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Title
Best Objective Response Rate (ORR), Defined as Complete Response (CR) or Partial Response (PR) at any Time on Study Based on PET-CT and/or CT scan as Assessed According to Lugano 2014 Response Criteria
Time Frame
Baseline through 2 years after partial response assessment (PRA) (up to a total of approximately 2.5 years)
Title
Duration of Response (DOR)
Time Frame
From the first occurrence of a response to disease progression, relapse, or death, whichever comes first (up to approximately 2.5 years)
Title
Anti-Drug Antibodies (ADAs) to Mosunetuzumab
Time Frame
At pre-defined intervals from Cycle 1, Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Title
ADAs to Polatuzumab Vedotin
Time Frame
At pre-defined intervals from Cycle 1, Day 1 through approximately 90 days after the last study treatment (cycle = 21 days)
Title
Progression-Free Survival (PFS)
Time Frame
From randomization to the first occurrence of disease progression, relapse, or death from any cause, whichever occurs first (up to approximately 2.5 years)
Title
PFS at 1 Year
Time Frame
Randomization to 1 Year
Title
Event-Free Survival (EFS)
Time Frame
From randomization to the first occurrence of disease progression or relapse, initiation of new anti-lymphoma therapy (NALT), or death from any cause, whichever occurs first (up to approximately 2.5 years)
Title
Time to Deterioration in the European Organization for Research and Treatment of Cancer Quality of Life - Core 30 Questionnaire (EORTC QLQ-C30) Physical Functioning and Fatigue
Time Frame
From baseline through follow-up (up to approximately 2.5 years)
Title
Time to Deterioration in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale
Time Frame
From baseline through follow-up (up to approximately 2.5 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for Phase Ib and Phase II Portions At least one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longest diameter Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2 Adequate hematologic function Inclusion Criteria for Phase Ib Portion Participants must also meet the following criteria for study entry into the Phase Ib portion: Histologically confirmed B-cell NHL according to the World Health Organization (WHO) 2016 classification expected to express the cluster of differentiation-20 (CD20) antigen Relapsed or refractory (R/R) B-cell NHL after at least one prior systemic lymphoma therapy Treatment with at least one prior CD20-directed therapy Group B only: no prior treatment with polatuzumab vedotin Inclusion Criteria for Phase II Portion Participants must also meet the following criteria for study entry in the Phase II portion: Previously untreated, histologically confirmed DLBCL according to WHO 2016 classification International Prognostic Index (IPI) score of 2-5 Exclusion Criteria Prior treatment with mosunetuzumab Prior allogenic stem-cell transplant Current Grade >1 peripheral neuropathy Participants with history of confirmed progressive multifocal leukoencephalopathy (PML) Known or suspected chronic active Epstein Barr virus (CAEBV), hepatitis B, hepatitis C (HCV), or Human Immunodeficiency Virus (HIV) Prior solid organ transplantation History of autoimmune disease Current or past history of central nervous system (CNS) lymphoma Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease Significant cardiovascular disease or pulmonary disease Clinically significant history of liver disease Recent major surgery within 4 weeks before the start of C1D1, other than superficial lymph node biopsies for diagnosis Exclusion Criteria for Phase Ib Portion Participants who also meet any of the following criteria will be excluded from study entry in the Phase Ib portion: Prior treatment with chemotherapy, immunotherapy, and biologic therapy 4 weeks prior to C1D1 Prior treatment with radiotherapy within 2 weeks prior to C1D1 Adverse events from prior anti-cancer therapy resolved to ≤Grade 1 (with the exception of alopecia and anorexia) Prior treatment with >250 mg/m^2 doxorubicin (or equivalent anthracycline dose) Exclusion Criteria for Phase II Portion Participants who also meet any of the following criteria will be excluded from study entry in the Phase II portion: Participants with transformed lymphoma Prior therapy for B-cell NHL
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of California; Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404-2023
Country
United States
Facility Name
Banner MD Anderson Cancer Center
City
Greeley
State/Province
Colorado
ZIP/Postal Code
85234
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0934
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903-4801
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Scott and White Hospital; Cancer Center
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Medical College of Wisconsin, Inc.
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3596
Country
United States
Facility Name
Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
LKH Steyr
City
Steyr
ZIP/Postal Code
4400
Country
Austria
Facility Name
Medizinische Universität Wien, Allgemeines Krankenhaus der Stadt Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Hanusch-Krankenhaus
City
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
CHU Henri Mondor; Service d'Oncologie Medicale
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Centre Henri Becquerel- Centre de Lutte Contre le Cancer
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Pusan National University Yangsan Hospital
City
Gyeongsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Maria Sklodowska-Curie Memorial Cancer Centre
City
Gliwice
ZIP/Postal Code
44-102
Country
Poland
Facility Name
Ma?opolskie Centrum Medyczne
City
Kraków
ZIP/Postal Code
30-501
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
City
Slupsk
ZIP/Postal Code
76-200
Country
Poland
Facility Name
Instytut Hematologii i Transfuzjologii; Klinika Zaburze? Hemostazy i Chorób Wewn?trznych
City
Warsaw
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Katedra i Klinika Hematologii; Nowotworów Krwi i Transplantacji Szpiku
City
Wroc?aw
Country
Poland
Facility Name
Institut Catala d?Oncologia Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Clinica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Seville
State/Province
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital San Pedro de Alcantara; Servicio de Hematología
City
Caceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
280146
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma

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