A Multicentre, Parallel Arm, Open-label Trial of Frontline R-CHOP/Pola-RCHP and Glofitamab in You… (NCT04914741) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Multicentre, Parallel Arm, Open-label Trial of Frontline R-CHOP/Pola-RCHP and Glofitamab in Younger, Higher Risk Patients With Diffuse Large B Cell Lymphoma (DLBCL)
Australia80 participantsStarted 2021-06-29
Plain-language summary
This is an open label, multi-centre, phase Ib/II, parallel arm study evaluating the safety and tolerability of glofitamab in addition to backbone chemotherapy consisting of R-CHOP or polatuzumab vedotin-RCHP for younger patients with higher-risk Diffuse Large B-cell Lymphoma or High Grade B-Cell Lymphoma.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18yo and ≤65yo at the time of signing consent
. Have a histologically confirmed diagnosis of one of the following, according to the 2016 WHO classification:
. DLBCL, NOS or DLBCL arising as a result of transformation of an indolent lymphoma
. HGBL, NOS
. HGBL with rearrangements of MYC and BCL2 and/or BCL6
. For DLBCL, and HGBL, NOS meets one of the following risk criteria:
. Considered fit for 6 cycles of full dose R-CHOP chemotherapy, as per the Investigator
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess safety of the combination of glofitamab and R-CHOP or pola-RCHP according to number of participants with treatment-related adverse events
Timeframe: From start of treatment till the end of study, assessed up to approximately 60 months
2
To evaluate the Relative Dose Intensity (RDI) of the chemotherapy backbone
Timeframe: From start of study treatment till the end of study treatment, assessed up to approximately 12 months
3
To evaluate the rates of early chemotherapy discontinuation
Timeframe: From start of study treatment till the end of study treatment, assessed up to approximately 12 months
. Inability to comply with protocol mandated hospitalisations and restrictions
. Prior systemic treatment of an underlying indolent lymphoma with an anthracycline-containing regimen
. Richter's syndrome
. Patients with known CNS involvement by lymphoma
. With the exception of rituximab, any prior treatment with systemic immunotherapeutic agents, including, but not limited to, radio-immuno-conjugates, antibody-drug conjugates, immune/cytokines, and monoclonal antibodies within 4 weeks or five half-lives of the drug, whichever is shorter, before the first dose of study drug
. With the exception of CHOP used as a first cycle of lymphoma treatment, any chemotherapeutic agent, or treatment with any other investigational agent within 4 weeks prior to study treatment
. Prior solid organ transplantation
. Prior autologous or allogeneic stem cell transplantation