Health TrialsbyHealthPanel

A Study of Glofitamab Plus GemOx Compared With Standard of Care in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

ConditionDiffuse Large B Cell Lymphoma (DLBCL)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Soochow University

About this trial

The purpose of this study is to evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (GemOx) versus standard of care (SOC) in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) who have relapsed early (within 1 year) or are primary refractory to first-line therapy. Participants will be randomly assigned in a 1:1 ratio to receive either the Glofitamab-GemOx combination regimen or SOC. The SOC arm consists of investigator's choice of salvage chemoimmunotherapy followed by autologous stem cell transplantation (ASCT) for eligible patients. The primary endpoint of the study is event-free survival (EFS).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed Informed Consent Form.

Age 18 years or older at the time of signing the Informed Consent Form.

Histologically proven diffuse large B-cell lymphoma (DLBCL), including transformation from follicular lymphoma.

Relapsed or refractory disease after first-line chemoimmunotherapy, defined as refractory disease (no complete remission to first-line therapy, progressive disease as best response, stable disease after 3-4 cycles, or partial response after 6-8 cycles/progression within 12 months of first-line therapy) or relapsed disease (complete remission followed by biopsy-proven relapse within 12 months of first-line therapy).

Disqualifiers

Contraindication to glofitamab components or a history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.

Not eligible for autologous stem cell transplantation (ASCT).

Prior solid organ transplantation.

History of Richter's transformation or of indolent disease to diffuse large B-cell lymphoma (DLBCL) or primary mediastinal B-cell lymphoma (PMBCL).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Obinutuzumab

    Drug

    A single 1000 mg dose is administered intravenously as pretreatment on Day 1 of Cycle 1 (7 days prior to the first glofitamab dose) to deplete peripheral B-cells and mitigate the risk of cytokine release syndrome (CRS).

  • Glofitamab

    Drug

    Glofitamab is administered intravenously using a step-up dosing schedule to mitigate CRS: Cycle 1 Day 8: 2.5 mg. Cycle 1 Day 15: 10 mg. Cycle 2-12 Day 1: 30 mg (target dose). Treatment continues for a maximum of 12 cycles (21-day cycles) or until disease progression/unacceptable toxicity.

  • Gemcitabine

    Drug

    Administered intravenously at 1000 mg/m² on Day 2 of Cycle 1, and then on Day 1 or 2 of subsequent cycles (Cycles 2-8).

  • Oxaliplatin

    Drug

    Administered intravenously at 100 mg/m² on Day 2 of Cycle 1, and then on Day 1 or 2 of subsequent cycles (Cycles 2-8).

  • Salvage Chemotherapy (Investigator's Choice)

    Drug

    Participants in the SOC arm will receive up to 2 cycles of investigator's choice salvage therapy among the following regimens: ICE ± R, DHAP ± R, GDP ± R, ESHAP ± R, GemOx ± R, or MINE ± R .

  • Autologous Stem Cell Transplantation (ASCT)

    Drug

    Participants in the SOC arm who achieve a CR or PR after salvage therapy will proceed to ASCT. This includes a conditioning regimen (e.g., BEAM) followed by autologous stem cell rescue and a recovery period.

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Glofit-GemOxExperimental treatment 4 interventions
Group B: SoCActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Event-Free Survival (EFS)

EFS is defined as the time from randomization to the earliest date of disease progression according to the Lugano Classification (2014), commencement of new anti-lymphoma therapy, or death from any cause, as determined by the investigator.

Time frame
From randomization until the first occurrence of an EFS event (disease progression, new therapy, or death), assessed up to approximately 48 months.

Secondary outcomes

1

Complete Response (CR) Rate

The proportion of participants whose best overall response is a CR on PET/CT or diagnostic CT during the study, as determined by the investigator according to the 2014 Lugano Response Criteria.

Time frame
From randomization to the end of study, up to approximately 48 months.
2

Objective Response Rate (ORR)

The proportion of participants whose best overall response is a Partial Response (PR) or a Complete Response (CR) during the study, as determined by the investigator according to the 2014 Lugano Response Criteria.

Time frame
From randomization to the end of study, up to approximately 48 months.
3

Progression-Free Survival (PFS)

The time from randomization to the first occurrence of disease progression according to the 2014 Lugano Response Criteria or death from any cause, whichever occurs first, as determined by the investigator.

Time frame
From randomization until disease progression or death, assessed up to approximately 48 months.
4

Duration of Response (DOR)

The time from the first occurrence of a documented objective response (CR or PR) to disease progression or death from any cause, whichever occurs first.

Time frame
From the date of first documented objective response until disease progression or death, assessed up to approximately 48 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Soochow University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: