GLORY: Glofit-GemOx With Liso-Cel For Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
The goal of this clinical trial is to assess the clinical efficacy of bridging therapy with glofitamab/gemcitabine/oxaliplatin (Glofit-GemOx) followed by lisocabtagene maraleucel (liso-cel) in relapsed/refractory large B-cell lymphomas. This clinical trial also aims to investigate other efficacy parameters of the combination of Glofit-GemOx plus liso-cel and assess the safety of the combination of Glofit-GemOx bridging plus liso-cel. The main questions it aims to answer are:
* How effective Glofit-GemOx bridged to liso-cel therapy is compared to liso-cel alone? * How will Glofit-GemOx bridged to liso-cel therapy affect other factors such as how long treatment effects last, how long patients survive after treatment, re-hospitalization rates, and more? * How many patients receiving Glofit-GemOx bridging to liso-cel will experience side effects of differing severities? Participants will receive an obinutuzumab intravenous infusion 3 days prior to undergoing a leukapheresis procedure. 2 days after leukapheresis, participants will receive 1-2 cycles of Glofit-GemOx therapy via intravenous infusion. After completing Glofit-GemOx therapy, participants will receive lymphodepleting chemotherapy via intravenous infusion for 3 consecutive days, 3-5 days prior to then receiving an intravenous infusion of liso-cel.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed large B-cell NHL including diffuse large B-cell lymphoma (DLBCL), either de novo or transformed from any indolent B-cell lymphoma, DLBCL NOS, primary mediastinal [thymic] large B-cell lymphoma (PMBCL), high grade B-cell lymphoma NOS, or high grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements [double/triple-hit lymphoma (DHL/THL)]; and grade 3B follicular lymphoma.
Relapsed or refractory to 1 prior line of systemic lymphoma therapy if relapse/refractory within 12 months of initial treatment. Previous therapy must have included a CD20-targeted agent and an anthracycline or alkylating agent. Patients may have received steroids and/or polatuzumab-rituximab (without bendamustine), and/or radiation therapy for disease control and/or palliation "holding therapy" between frontline therapy and protocol registration and this will not be considered an additional line of systemic therapy.
Intent and eligibility to proceed to therapy with lisocabtagene maraleucel
Adult patients ≥ 18 years
Disqualifiers
History of prior malignancy that could affect compliance with the protocol or interpretation of results, except for the following: Non-melanoma skin cancers, in situ malignancies, prostate cancer followed with watchful waiting, indolent lymphoma, any previously treated malignancy felt at low risk for recurrence.
Evidence of disease (such as severe or uncontrolled systemic diseases) that, in the investigator's opinion, make it undesirable for the patient to participate in the study or that would jeopardize compliance with the protocol
Treatment with prior CAR T-cell therapy.
Treatment with prior CD20:CD3 bispecific antibody therapy.
Trial design
Design model
Single group
Treatments tested in this trial
Obinutuzumab
DrugIntravenous infusion received once, 5 days prior to receiving the first doses of glotfitamab, gemcitabine, and oxaliplatin.
Glofitamab
DrugIntravenous infusion received on days 1, 3, 8, and 15 of cycle 1 and on day 15 of the optional cycle 2 (each cycle is 21 days).
Gemcitabine & oxaliplatin
DrugIntravenous infusions received on day 1 of cycle 1 and an optional cycle 2 (each cycle is 21 days).
Leukapheresis
Procedure/SurgeryProcedure to collect stem cells for modification that will occur 2 days prior to administration of the first doses of glofitamab, gemcitabine, and oxaliplatin.
Lymphodepleting chemotherapy
DrugIntravenous infusions of cyclophosphamide and fludarabine administered for 3 consecutive days 3-5 days prior to receive lisocabtagene maraleucel.
LISOCABTAGENE MARALEUCEL
DrugIntravenous infusion of participant's re-manufactured stem cells administered one 3-5 days after completing lymphodepleting chemotherapy.
Treatment groups
56 Participants
are divided into 1 treatment groupGroup A: Liso-Cel after Glofit-GemOx bridging therapyExperimental treatment 6 interventions
Trial outcomes
Primary outcomes
1
Complete Response Rate (CRR) to lisocabtagene maraleucel
The complete response rate (CRR) is defined as the proportion of subjects achieving an objective response of complete response prior to start of another non-study anticancer therapy. CRR is based on the best overall response post-lisocabtagene maraleucel infusion. CRR will be defined according to the Lugano Classification.
Time frame
Screening to start of another non-study anticancer therapy or for up to 2 years from the day the last participant is enrolled, whichever occurs first.Secondary outcomes
1
Overall Response Rate to Glofit-GemOx bridging
Overall response rate is the proportion of participants achieving partial response (PR) or complete response (CR) according to the Lugano Classification. Overall response rate is based on the PR or CR to glofitamab, gemcitabine, and oxaliplatin (Glofit-GemOx) bridging therapy.
Time frame
Screening to start of another non-study anticancer therapy or for up to 2 years from the day the last participant is enrolled, whichever occurs first.2
Progression-Free Survival (PFS) after lisocabtagene maraleucel
Progression-free survival (PFS) is defined as the time from registration to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. PFS is based on the lisocabtagene maraleucel infusion. PFS will be summarized using Kaplan-Meier estimates.
Time frame
Registration to death or up to 2 years after the day of the lisocabtagene maraleucel infusion.3
Overall Survival (OS) after lisocabtagene maraleucel
Overall survival (OS) is defined as the time from registration to death due to any cause or censored at date last known alive. OS is based on the lisocabtagene maraleucel infusion. OS will be summarized using Kaplan-Meier estimates.
Time frame
Registration to death or up to 2 years after the day of the lisocabtagene maraleucel infusion.4
Overall Response Rate (ORR) to lisocabtagene maraleucel
Overall response rate is the proportion of participants achieving partial response (PR) or complete response (CR) according to the Lugano Classification. Overall response rate is based on the PR or CR to lisocabtagene maraleucel infusion.
Time frame
Screening to start of another non-study anticancer therapy or for up to 2 years from the day the last participant is enrolled, whichever occurs first.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Bristol-Myers Squibb
Collaborator
Source ClinicalTrials.gov
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