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 range18 Years – 65 Years
SexALL
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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
✓. ECOG performance status (appendix 5) of:
Exclusion criteria
✕. 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
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
✕. 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