Glofit and Obin in Follicular Lymphoma and Marginal Zone Lymphoma
A Phase 2 Study of Glofitamab and Obinutuzumab for First-line Treatment of Follicular Lymphoma and Marginal Zone Lymphoma
1 other identifier
interventional
47
1 country
4
Brief Summary
The purpose of this study is to determine how effective and safe the combination of glofitamab and obinutuzumab is in treating patients with Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL) who have not received other treatments for their lymphoma. The names of the study drugs involved in this study are:
- Glofitamab (a type of immunotherapy)
- Obinutuzumab (a type of immunotherapy)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2023
Longer than P75 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2023
CompletedFirst Posted
Study publicly available on registry
March 24, 2023
CompletedStudy Start
First participant enrolled
July 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2029
March 16, 2026
March 1, 2026
3 years
March 13, 2023
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
End of Treatment (EOT) Complete Metabolic Response (CMR) Rate
EOT CMR rate defined as the proportion of participants achieving CR per PET/CT Lugano 2014 criteria (protocol appendix B) at the EOT assessment: PET-CT, score 1, 2, or 3 with or without a residual mass on a 5-point scale (5PS).
(Cycle 1 = 36 days, cycle 2 - 12 = 21 days), up to 267 days
Secondary Outcomes (18)
Best Partial Metabolic Response (PMR) Rate
(Cycle 1 = 36 days, cycle 2 - 12 = 21 days), up to 267 days
Best Complete Metabolic Response (CMR) Rate
(Cycle 1 = 36 days, cycle 2 - 12 = 21 days), up to 267 days
Best Objective Metabolic Response (OMR) Rate
(Cycle 1 = 36 days, cycle 2 - 12 = 21 days), up to 267 days
EOT Partial Metabolic Response (PMR) Rate
(Cycle 1 = 36 days, cycle 2 - 12 = 21 days), up to 267 days
EOT Objective Metabolic Response (OMR) Rate
(Cycle 1 = 36 days, cycle 2 - 12 = 21 days), up to 267 days
- +13 more secondary outcomes
Study Arms (2)
Obinutuzumab + Glofitamab for Follicular Lymphoma
EXPERIMENTALParticipants will undergo study procedures as outlined: * Imaging scans (CT or PET) at screening and after cycles 3, 7, and 12 of treatment. * Bone marrow biopsy at baseline. * Cycle 1 * Days -21, -14, -7, 0 of 36 day cycle: Predetermined dose of Obinutuzumab. * Days 1 and 8 of 36 day cycle: Predetermined dose of Glofitamab. (First dose will be administered in the hospital.) * Cycles 2 - 12: o Day 1 of 21 day cycle: Predetermined dose of Glofitamab. * Bone marrow biopsy within 2 weeks of end of treatment. * Imaging scans (CT or PET) at 12, 18, and 24 months after treatment initiation. * Follow up visits up to 5 years after treatment completion.
Obinutuzumab + Glofitamab for Marginal Zone Lymphoma
EXPERIMENTALParticipants will undergo study procedures as outlined: * Imaging scans (CT or PET) at screening and after cycles 3, 7, and 12 of treatment. * Bone marrow biopsy at baseline. * Cycle 1 * Days -21, -14, -7, 0 of 36 day cycle: Predetermined dose of Obinutuzumab. * Days 1 and 8 of 36 day cycle: Predetermined dose of Glofitamab. (First dose will be administered in the hospital.) * Cycles 2 - 12: o Day 1 of 21 day cycle: Predetermined dose of Glofitamab. * Bone marrow biopsy within 2 weeks of end of treatment. * Imaging scans (CT or PET) at 12, 18, and 24 months after treatment initiation. * Follow up visits up to 5 years after treatment completion.
Interventions
Humanized glycoengineered type II anti-CD20 monoclonal antibody, via IV infusion.
T-cell bispecific humanized monoclonal antibody, via IV infusion.
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis of either FL (grade 1-3A) or MZL (any subtype) with review of the diagnostic pathology specimen at one of the participating institutions. Patients with active histologic transformation are excluded.
- No prior systemic therapy for FL or MZL. Prior treatment with radiation therapy or short course steroids is allowed.
- Meets at least one criterion to begin treatment based on the modified GELF criteria:
- Symptomatic adenopathy
- Organ function impairment due to disease involvement, including cytopenias due to marrow involvement (WBC \<1.5x109/L; absolute neutrophil count \[ANC\] \<1.0x109/L, Hgb \<10g/dL; or platelets \<100x109/L)
- Constitutional symptoms
- Maximum diameter of disease \> 7cm
- \>3 nodal sites of involvement
- Risk of local compressive symptoms
- Splenomegaly (craniocaudal diameter \> 16cm on CT imaging)
- Clinically significant pleural or peritoneal effusion
- Leukemic phase (\>5x109/L circulating malignant cells)
- Rapid generalized disease progression
- Renal infiltration
- Bone lesions
- +14 more criteria
You may not qualify if:
- Patients who require systemic immunosuppressive therapy for an ongoing medical condition will be excluded. For corticosteroids, patients receiving a prednisone dose of \>10 mg daily (or equivalent) will not be eligible. A short course of steroids (up to 14 days, not exceeding 40 mg dexamethasone or equivalent in a single day) for symptom palliation is allowed, in which case patients should be off steroids at least 7 days prior to treatment start.
- Patients with bulky cervical adenopathy that is 1) compressing the upper airway or 2) in close proximity to the upper airway and could result in airway compression during a tumor flare event).
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy unless in consultation with an allergy specialist they are deemed eligible for retreatment with desensitization.
- Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia).
- Patients with known HIV infection or hepatitis B or C infection. Testing for HIV is optional. Testing for hepatitis B and C is mandatory. Patients with hepatitis B core Ab positivity but negative surface antigen and negative viral load may be enrolled if they can be treated with a prophylactic agent (e.g., entecavir); patients with hepatitis C seropositivity who have a negative viral load can also be enrolled.
- Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
- Prior history of another malignancy (except for non-melanoma skin cancer or in situ cervical or breast cancer) unless disease free for at least 2 years. Patients with prostate cancer (Gleason score 6-7) are allowed if PSA is less than 1 ng/mL.
- Patients should not have received immunization with lives or live attenuated vaccine within one week of study entry or during study period.
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study or limit adherence to study requirements.
- Patients with any one of the following currently on or in the previous 6 months will be excluded: myocardial infarction, congenital long QT syndrome, torsade de pointes, unstable angina, coronary/peripheral artery bypass graft, or cerebrovascular accident.
- Patients with New York Heart Association Class III or IV heart failure.
- Inability to comply with protocol mandated hospitalizations and restrictions
- Patients who are pregnant, breast-feeding, or intending to become pregnant during the study.
- Prior solid organ or allogeneic stem cell transplantation
- History of known or suspected hemophagocytic lymphohistiocytosis (HLH).
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Reid Merryman, MDlead
- Genentech, Inc.collaborator
Study Sites (4)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Columbia University Irving Medical Center
New York, New York, 10032, United States
Mount Sinai Medical Center
New York, New York, 10128, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Reid Merryman, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 13, 2023
First Posted
March 24, 2023
Study Start
July 18, 2023
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2029
Last Updated
March 16, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.