A Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab in C… (NCT06806033) | Clinical Trial Compass
RecruitingPhase 2
A Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
United States100 participantsStarted 2025-03-05
Plain-language summary
This Phase II trial evaluates the optimization of the cytokine release syndrome (CRS) profile for glofitamab in combination with gemcitabine and oxaliplatin (Glofit-GemOx) in participants with relapsed or refractory aggressive B-cell Non-Hodgkin's lymphoma. The study utilizes an optimized steroid premedication regimen and monitoring schedule specifically designed to enable the administration of the treatment regimen in an outpatient setting.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically confirmed large B-cell lymphoma (de novo or transformed from FL) with one of the following diagnoses according to World Health Organization, fifth edition: DLBCL Not Otherwise Specified (NOS); High-Grade B-Cell Lymphoma (HGBL), NOS; DLBCL/HGBL with MYC and BCL2 rearrangements
* R/R disease, defined as: relapsed = disease that has recurred following a response that lasted \>/= 6 months after completion of the last line of therapy; refractory = disease that did not respond to or that progressed \< 6 months after completion of the last line of therapy
* At least one line of prior systemic therapy
* Participants who have failed only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)
* 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
* Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2
* According to the investigator's judgment, participants should be able to receive the step-up dose regimen in an outpatient setting
* Adequate hematologic and renal function
Exclusion Criteria:
* Prior enrollment in Studies GO41943 (NCT04313608), GO41944 (STARGLO; NCT04408638), or Study GO44900 (NCT06624085)
* Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation
* Any history of Waldenstrom's macroglobulinemia
* Primary…
What they're measuring
1
Incidence of cytokine release syndrome (CRS)
Timeframe: Up to approximately 5 years
Trial details
NCT IDNCT06806033
SponsorHoffmann-La Roche
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-01-31
Contact for this trial
Reference Study ID Number: GO45434 https://forpatients.roche.com/