We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate Glofitamab as Single Agent Administered After Pretreatment With Obinutuzumab in Chinese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04657302
Recruitment Status : Active, not recruiting
First Posted : December 8, 2020
Last Update Posted : October 28, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaluate the pharmacokinetics, safety, tolerability, and efficacy of glofitamab as a single agent following a fixed single dose of obinutuzumab in Chinese patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have failed two or more lines of systemic therapy.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: Obinutuzumab Drug: Glofitamab Drug: Tocilizumab Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Efficacy of Glofitamab as Single Agent Administered After a Fixed, Single Dose Pretreatment of Obinutuzumab in Chinese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Actual Study Start Date : January 8, 2021
Estimated Primary Completion Date : August 24, 2023
Estimated Study Completion Date : August 24, 2023


Arm Intervention/treatment
Experimental: R/R DLBCL
Participants will receive a fixed dose of obinutuzumab pre-treatment followed by glofitamab on Cycle 1 Days 8 and 15, then every 3 weeks (Q3W) from Cycles 2-12 (cycle length = 21 days).
Drug: Obinutuzumab
Participants will receive 1000 mg of intravenous (IV) obinutuzumab on Cycle 1 Day 1.

Drug: Glofitamab
Participants will receive 2.5 mg of IV glofitamab Cycle 1 Day 8, 10 mg at Cycle 1 Day 15, and 30 mg on Day 1 of Cycles 2-12 Q3W (cycle length = 21 days).

Drug: Tocilizumab
Participants will receive tocilizumab as needed to manage cytokine release syndrome (CRS).




Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to 3.5 years ]
  2. Serum Concentration of Glofitamab [ Time Frame: At pre-defined intervals up to 3.5 years ]
  3. Total Exposure (AUC) of Glofitamab [ Time Frame: At pre-defined intervals up to 3.5 years ]
  4. Maximum Serum Concentration (Cmax) of Glofitamab [ Time Frame: At pre-defined intervals up to 3.5 years ]
  5. Minimum Serum Concentration (Cmin) of Glofitamab [ Time Frame: At pre-defined intervals up to 3.5 years ]
  6. Clearance of Glofitamab [ Time Frame: At pre-defined intervals up to 3.5 years ]
  7. Volume of Distribution at Steady State (Vss) of Glofitamab [ Time Frame: At pre-defined intervals up to 3.5 years ]
  8. Half-life (T1/2) of Glofitamab [ Time Frame: At pre-defined intervals up to 3.5 years ]
  9. Complete Response Rate (CRR) as Assessed by an Independent Review Committee (IRC) [ Time Frame: Up to 3.5 years ]
  10. Percentage of Participants with Anti-Drug Antibodies (ADA) [ Time Frame: Up to 3.5 years ]

Secondary Outcome Measures :
  1. Investigator-Assessed CRR [ Time Frame: Up to 3.5 years ]
  2. Objective Response Rate (ORR) as Assessed by IRC [ Time Frame: Up to 3.5 years ]
  3. ORR as Assessed by Investigator [ Time Frame: Up to 3.5 years ]
  4. Duration of Objective Response (DOR) as Assessed by IRC and Investigator [ Time Frame: Up to 3.5 years ]
  5. Duration of Complete Response (CR) as Assessed by IRC and Investigator [ Time Frame: Up to 3.5 years ]
  6. Progression-Free Survival (PFS) as Determined by IRC and Investigator [ Time Frame: Up to 3.5 years ]
  7. Overall Survival (OS) [ Time Frame: Up to 3.5 years ]
  8. Time to First Overall Response (TFOR) as Assessed by IRC and Investigator [ Time Frame: Up to 3.5 years ]
  9. Time to First Complete Response (TFCR) as Assessed by IRC and Investigator [ Time Frame: Up to 3.5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically-confirmed DLBCL
  • Participants must have relapsed or failed to respond to at least two lines of prior systemic therapy (including at least one prior regimen containing anthracycline, and at least one containing an anti-CD20-directed therapy)
  • Participants must have measurable disease: at least one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension; or at least one bi-dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longest dimension
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 1 or 1
  • Adverse events from prior anti-cancer therapy must have resolved to Grade </=1
  • Adequate liver, hematological, and renal function
  • Negative serum pregnancy test within 7 days prior to study treatment in women of childbearing potential
  • Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol, and agree to refrain from donating eggs during the treatment period and for at least 18 months after the final dose of obinutuzumab, 2 months after the final dose of glofitamab, and 3 months after the final dose of tocilizumab (if applicable)
  • Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol, and agree to refrain from donating sperm during the treatment period and for at least 3 months after the final dose of obinutuzumab, 4 months after the final dose of glofitamab, and 2 months after the final dose of tocilizumab (if applicable)
  • Reside in the People's Republic of China

Exclusion Criteria:

  • Richter's transformation
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection within 4 weeks prior to first study treatment
  • Suspected or latent tuberculosis
  • Positive for HIV, hepatitis C (HCV), or hepatitis B (HBV)
  • Known or suspected chronic active Epstein-Barr virus infection
  • Known or suspected history of hemaphagocytic lymphohistiocytosis (HLH)
  • Prior treatment with systemic immunotherapeutic agents
  • History of treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents
  • Documented refractoriness to an obinutuzumab monotherapy-containing regimen
  • Treatment with standard radiotherapy, any chemotherapeutic agent, including CAR T therapy
  • Prior solid organ or allogenic stem cell transplantation
  • Autologous stem cell transplantation within 100 days prior to obinutuzumab infusion
  • Active autoimmune disease requiring treatment
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
  • History of confirmed progressive multifocal leukoencephalopathy (PML)
  • Current or past history of CNS lymphoma
  • Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
  • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders, and known autoimmune diseases
  • Major surgery or significant traumatic injury < 28 days prior to obinutuzumab infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment
  • Another invasive malignancy in the last 2 years
  • Significant cardiovascular disease
  • Administration of a live, attenuated vaccine within 4 weeks before obinutizumab infusion, or anticipation that one will be required during the study
  • Systemic immunosuppresive medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04657302


Locations
Layout table for location information
China
Beijing Cancer Hospital
Beijing, China, 100142
Peking University Third Hospital
Beijing, China, 100191
West China Hospital, Sichuan University
Chengdu, China, 610041
Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology
Guangzhou City, China, 510060
Harbin Medical University Cancer Hospital
Harbin, China, 150081
Jiangsu Province Hospital
Nanjing, China, 210036
Tianjin Cancer Hospital
Tianjin, China, 300060
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04657302    
Other Study ID Numbers: YO42610
First Posted: December 8, 2020    Key Record Dates
Last Update Posted: October 28, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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).

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Obinutuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents