EUCTR2021-006326-48-DKActive, not recruitingPhase 1
A PHASE I/II, OPEN-LABEL, SINGLE-ARM, TWO-PART TRIAL TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI-TUMOR ACTIVITY OF GLOFITAMAB IN COMBINATION WITH CHEMOIMMUNOTHERAPY IN PEDIATRIC AND YOUNG ADULT PARTICIPANTS WITH RELAPSED/REFRACTORY MATURE B-CELL NON-HODGKIN LYMPHOMA
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- F.Hoffmann-La Roche Ltd
- Enrollment
- 65
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •? Age 6 months to <18 years at the time of signing Informed Consent for Part 1 and Cohort B of the study, and age 6 months to <=30 years old at the time of signing Informed Consent for Part 2 of the study
- •? Histologically re-confirmed diagnosis, via tissue biopsy, or bone marrow aspirate, pleural effusion, or ascites, prior to study entry of aggressive mature B-cell non-Hodgkin lymphoma (B-NHL) that expresses CD20 (reconfirmed by immunohistochemistry [IHC]), or flow cytometry if IHC is not possible including Burkitt lymphoma (BL), Burkitt leukemia (BAL) (mature B-cell leukemia fragment antigen-binding [FAB] L3), diffuse large B-cell lymphoma (DLBCL), and primary mediastinal large B-cell lymphoma (PMBCL), at the time of first relapsed or refractory (R/R) disease for Cohort A and second or greater R/R disease for Cohort B
- •? Refractory or relapsed disease (i.e., prior treatment was ineffective or intolerable) following first-line standard-of-care chemoimmunotherapy for Cohort A and following at least two prior systemic chemoimmunotherapy regimens and who have exhausted all available established therapies for Cohort B
- •? Measurable disease
- •? Adequate performance status, as assessed according to the Lansky or Karnofsky Performance Status scales
- •? Adequate bone marrow function
- •? Adequate liver and renal function
- •? Negative serologic or polymerase chain reaction (PCR) test results for acute or chronic hepatitis B virus (HBV) infection
- •? Negative test results for hepatitis C virus (HCV) and human immunodeficiency virus (HIV)
- •? Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) PCR test and negative result within 48 hours before study treatment
- •? Vaccination status in line with the French National guidelines/recommendations (French vaccine strategy council [COSV])
- •? For female participants of childbearing potential, or who will reach childbearing potential during the study: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for at least 18 months after obinutuzumab pretreatment, 2 months after the final dose of glofitamab, 12 months after the final dose of rituximab and/or ifosfamide, carboplatin, and etoposide (ICE), or 3 months after the final dose of tocilizumab
- •? For male participants who are expected to reach sexual maturity during the study, or have already reached sexual maturity by the screening visit: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for at least 3 months after pretreatment with obinutuzumab, 2 months after the final dose of glofitamab, 6 months after the final dose of rituximab and/or ICE, or 2 months after the last dose of tocilizumab (if applicable), whichever is longer, to avoid exposing the embryo
- •? Participants and/or caregivers who are willing and able to complete clinical outcome assessments throughout the study using either paper or interviewer methods
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 55
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
- •? Isolated CNS disease of mature B-NHL without systemic involvement, and primary central nervous system (CNS) lymphoma
- •? Receipt of glofitamab prior to study enrollment
- •? Ongoing adverse events from prior anti-cancer therapy that were not resolved to Grade <=1
- •?Participants with active infections which are not resolved prior to Day 1 of Cycle 1
- •? Grade >=3 adverse events, with the exception of Grade 3 endocrinopathy managed with replacement therapy
- •? Prior solid organ transplantation
- •? Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
- •? Known or suspected chronic active Epstein-Barr viral infection (CAEBV)
- •? Active autoimmune disease requiring treatment
- •? History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
- •? History of confirmed progressive multifocal leukoencephalopathy
- •? Current or past history of uncontrolled non-malignant CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
- •? Evidence of significant and uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
- •? Major surgery or significant traumatic injury <28 days prior to the obinutuzumab pretreatment infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment
- •? Administration of a live, attenuated vaccine within 4 weeks before the start of study treatment (obinutuzumab pretreatment) or at any time during the study treatment period and within 12 months after end of study treatment
- •? Participants with any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
- •? Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- •Exclusion criteria applicable to Cohort A only
- •? Receipt of any R-ICE chemoimmunotherapy prior to study enrollment into Cohort A
- •? Receipt of more than one prior line of standard-of-care B-NHL chemoimmunotherapy
- •? Prior allogeneic or autologous stem cell transplantation (SCT)
- •Exclusion criteria applicable to Cohort B only
- •? Prior treatment with systemic chemotherapy and immunotherapeutic anticancer agents
- •? Patients with uncontrolled CNS involvement
- •? Prior allogeneic or autologous SCT <=100 days post-transplant prior to enrollment
- •? Presence of Grade >=2 acute or extensive chronic graft -versus-host disease (GVHD) in participants who received prior allogeneic hematopoietic stem cell transplantation (HSCT)
- •?Prior treatment with systemic immunosuppressive agents for treatment of GVHD, within 4 weeks or five half-lives of the drug, whichever is shorter, before Cycle 1 Day 1
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