RecruitingB-Cell Non-Hodgkins Lymphoma

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

Eligible age

18+ yrs

Accepts

All genders

Locations

18 states

Healthy volunteers

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About this study

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.

Sponsor: Hoffmann-La Roche

You may qualify if…

✓ 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

You may not qualify if…

✕ 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 mediastinal B-cell lymphoma
✕ 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
✕ Contraindication to obinutuzumab, gemcitabine or oxaliplatin, or tocilizumab
✕ Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
✕ Prior treatment with gemcitabine or oxaliplatin