GO43878 - A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY EVALUATING GLOFITAMAB AS A SINGLE AGENT VERSUS INVESTIGATOR S CHOICE IN PATIENTS WITH RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA
H
Huda Salman
Primary Investigator
Enrolling By Invitation
18-100 years
All
Phase
3
3 participants needed
1 Location
Brief description of study
What is the purpose of this study?
The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared with an investigator's choice of either rituximab plus bendamustine (BR), or lenalidomide with rituximab (R-Len) in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Lymphoma
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion Criteria:
- Life expectancy at least 12 weeks
- Histologically-confirmed MCL, with documentation of either overexpression of cyclin D1 or the presence of t(11:14)
- Relapsed (disease progression after the last treatment regimen) or refractory (failure to achieve a partial or complete response from the last treatment regimen) disease
- At least 1 line of prior systemic therapy including a BTK inhibitor and additional systemic therapy option
- Confirmed availability of tumor tissue, unless deemed unsafe per investigator assessment
- At least one bi-dimensionally measurable (defined as at least 1.5 cm) nodal lesion, or one bi-dimensionally measurable (at least 1 cm) extranodal lesion, as measured on CT scan
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Negative HIV test at screening
- Adequate hematological function
Exclusion Criteria:
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of tocilizumab, 2 months after the final dose of glofitamab, whichever is longer
- Leukemic, non-nodal MCL
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
- Contraindication to obinutuzumab or rituximab, and either bendamustine or lenalidomide
- Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
- Prior treatment with CAR-T cell therapy
- Treatment with systemic therapy or BTK inhibitors, or any investigational agent for the purposes of treating cancer within 2 weeks or 5 half-lives (whichever is shorter) prior to first study treatment
- Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma
- Current or history of CNS disease, such as stroke, epilepisy, CNS vasculitis, or neurodegenerative disease
- History of other malignancy that could affect compliance with the protocol or interpretation of results
- Significant or extensive cardiovascular disease
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment or any major episode of infection within 4 weeks prior to the first study treatment
- Suspected or latent tuberculosis
- Positive test for hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Known or suspected chronic active Epstein-Barr viral infection (EBV)
- Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
- Known history of progressive multifocal leukoencephalopathy (PML)
- Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better
- Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study
- Prior solid organ transplantation or allogenic stem cell transplant
- Eligibility for stem cell transplantation (SCT)
- Active autoimmune disease requiring treatment
- Prior treatment with systemic immunosuppressive medications within 2 weeks or five half-lives (whichever is shorter) prior to the first dose of study treatment
- Corticosteroid therapy within 2 weeks prior to first dose of study treatment
- Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis
- Clinically significant history of cirrhotic liver disease
Updated on
13 Nov 2024.
Study ID: CTO-GO43878, 23029
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