BridgeMD
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of Glofitamab in Monotherapy and in Combination with Chemoimmunotherapy in Pediatric and Young Adult Participants with Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma
EU CTIS ID: 2023-504264-41-00
What this study is testing
To evaluate the efficacy of glofitamab in combination with rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) chemoimmunotherapy, as assessed by the investigator based on achievement of a complete response (CR) To evaluate the safety and tolerability of glofitamab in combination with R-ICE chemoimmunotherapy To determine the pharmacokinetics of glofitamab alone and in combination with R-ICE chemoimmunotherapy
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 6 months to <18 years at the time of signing Informed Consent for Cohort A Part 1 and Cohort B of the study, and age 6 months to < 30 years old at the time of signing Informed Consent for Cohort A Part 2 of the study Cohort A Part 2–18 up to < 30 years old, is restricted to young adults with first relapsed or refractory (R/R) aggressive mature B-NHL for whom no alternative standard-of-care treatment is available
- 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, defined as – 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 or – Percentage of bone marrow involvement with lymphoma cells defined by cytomorphological analysis of bone marrow aspirates
- Adequate performance status, as assessed according to the Lansky or Karnofsky Performance Status scales
- Adequate bone marrow, liver and renal function
- Negative test results for hepatitis B and hepatitis C viruses (HBV and HCV), human immunodeficiency virus (HIV) and severe-acute-respiratory-syndrome-related coronavirus 2 (SARS-CoV-2).
You likely can't join if
- Exclusion criteria applicable to both Cohorts A and B - Isolated CNS disease of mature B-NHL without systemic involvement, and primary central nervous system (CNS) lymphoma
- Exclusion criteria applicable to Cohorts A only - Receipt of glofitamab prior to study enrollment
- Exclusion criteria applicable to Cohort A only - Receipt of any R-ICE chemoimmunotherapy prior to study enrollment into Cohort A
- Exclusion criteria applicable to Cohort A only - Receipt of more than one prior line of standard-of-care B-NHL chemoimmunotherapy
- Exclusion criteria applicable to Cohort B only - Prior treatment with standard radiotherapy (within 2 weeks before Day 1 of Cycle 1), systemic chemotherapy and immunotherapeutic anticancer agents (within 4 weeks or five half-lives of the drug, before Day 1 of Cycle 1)
- Exclusion criteria applicable to Cohort B only - Patients with uncontrolled CNS involvement
The study team makes the final eligibility decision.
Where it's taking place
- China
- Australia
- United States
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; Australia; United States; Korea, Republic of. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.