BridgeMD
A Study to Understand the Optimization of the Cytokine Release Syndrome Profile for Glofitamab along with Gemcitabine Plus Oxaliplatin in Patients with Relapsed/Refractory Aggressive B-Cell Non-Hodgkin’s Lymphoma
EU CTIS ID: 2024-516791-15-00
What this study is testing
To evaluate the frequency of cytokine release syndrome (CRS)
- Therapeutic exploratory (Phase II)
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
- Life expectancy ≥ 12 weeks
- Participant with histologically confirmed diffuse large B-cell lymphoma, (de novo or transformed from a follicular lymphoma) with one of the following diagnoses according to World Health Organization, fifth edition (Alaggio et al. 2022):-DLBCL not otherwise specified (NOS) - High-Grade B-Cell Lymphoma (HGBL), NOS; – DLBCL/HGBL with myelocytomatosis proto-oncogene (MYC) and B-cell lymphoma 2 (BCL2) rearrangements
- Relapsed / refractory disease
- At least one prior line of systemic therapy - Participants may have undergone ASCT prior to recruitment - Local therapies (e.g., radiotherapy) will not be considered as lines of therapy
- Participants who have failed one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant
- At least one bi-dimensionally measurable ( > 1.5 cm) nodal lesion, or one bi-dimensionally measurable ( > 1 cm) extranodal lesion, as measured on CT scan
You likely can't join if
- Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation
- Any history of Waldenström’s macroglobulinemia
- Primary mediastinal B-cell lymphoma
- Contraindication to obinutuzumab, gemcitabine or oxaliplatin, or tocilizumab
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Australia
- United States
- Canada
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, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Australia; United States; Canada. 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.