The Double-T trial is a prospective, randomized, single-arm, open-label, multicenter phase II trial investigating a double T-cell therapy strategy, which includes glofitamab with gemcitabine/oxaliplatin (Glofi-Gem/Ox) prior to and glofitamab monotherapy consolidation after standard of care Chimeric Antigen Receptor (CAR)-T cell therapy in high-risk 2nd line relapsed/refractory Large B-Cell Lymphoma (r/r LBCL) patients.
Data on safety, efficacy, and quality of life (QoL) will be collected and analyzed.
Patient* has given written informed consent.
Patient is 18-80 years of age at time of signing the written informed consent
Patient has histologically confirmed diagnosis of large B-cell lymphoma by local pathologist at time of relapse.
Patient received R-CHOP based first-line therapy containing a CD20-antibody and anthracyclines.
Patient has HIV infection of any stage as determined by presence of anti-HIV antibodies (confirmatory test) and / or presence of RNA confirmed by PCR during screening
Surgically cured carcinoma in-situ
Other kinds of cancer without evidence of disease for at least 3 years
Patient has known hypersensitivity to any component of the Glofitamab, Obinutuzumab, Yescarta and/or Breyanzi formulation formulation as well as a known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion protein and/or any known contraindication (including hypersensitivity) to one of the other trial drugs
Single group
Glofitamab, Gemcitabine, and Oxaliplatin as Induction Therapy
DrugInduction Therapy before Standard of Care CAR-T Cell therapy
Glofitamab as Consolidation therapy
DrugConsolidation with Glofitamab after CAR-T Cell Therapy
CRR@EOT
Complete response rate (CRR) at end of treatment (CCR@EOT), defined as proportion of patients who achieved complete response (CR) at the end of trial treatment (EOT) as per Lugano classification
CCR@pIT and CCR@3MpCT
CRR post induction (CCR@pIT) and at 3 months post-CAR-T cell infusion (CCR@3MpCT), defined as proportion of patients who achieved complete response after two cycles induction treatment and 3 months after CAR-T cell infusion as per Lugano classification
Overall CRR
Overall CRR, defined as proportion of patients who achieved CR as best overall response (BOR)
ORR post induction, at 3 months post-CAR-T cell infusion, and at EOT
Objective Response rate (ORR) post induction (OOR@pIT), at 3 months post-CAR T cell infusion (ORR@3MpCT) and at end of trial treatment (ORR@EOT), defined as proportion of patients who achieved complete or partial response (CR/PR) after 2 cycles of induction treatment, at 3 months after CAR-T cell infusion and at the end of the treatment
Overall ORR
Overall ORR, defined as proportion of patients who achieved CR/PR as BOR
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Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Lead sponsor
Universitätsklinikum Düsseldorf, Germany
Collaborator
Roche Pharma AG
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
