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G-Pola-GemOx in Refractory/Relapsed Aggressive B-Cell Lymphoma

ConditionAggressive B-Cell Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14+
SponsorNavy General Hospital, Beijing

About this trial

The goal of this phase 2 trial is to test the safety and efficacy of G-Pola-GemOx as induction therapy in patients with Refractory/Relapsed Aggressive B-Cell Lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically confirmed Aggressive B-Cell Lymphoma (Including but not limited to diffuse large B-cell lymphoma, mantle cell lymphoma, Burkitt lymphoma, high-grade B-cell lymphoma, etc. according World Health Organization (WHO) classification;

Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).

Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted;

Patient is willing and able to adhere to the study visit schedule and other protocol requirements;

Disqualifiers

Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.

Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.

Pregnant or lactating women

Trial design

Design model

Single group

Treatments tested in this trial

  • Glofitamab, Polatuzumab Vedotin, Gemcitabine, and Oxaliplatin as Induction Therapy

    Drug

    Patients were treated by Glofitama(Cycle 1: D8, 2.5mg, D15, 10mg; followed by the target dose of 30mg on D1 of Cycle 2-12), Polatuzumab Vedotin(1.8mg/kg iv qd d1), Gemcitabine (1000 mg/m2 iv qd d2), Oxaliplatin (100 mg/m2 iv qd d2) as induction therapy.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Induction TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall Response Rate (ORR)

ORR was defined as the proportion of patients who achieved CR or PR as their best response

Time frame
1 year

Secondary outcomes

1

Overall Survival (OS)

OS was defined as time from diagnosis to death from any cause or the last follow-up

Time frame
through study completion, an average of 2 years
2

Progression Free Survival (PFS)

For patients in morphologic remission, documented relapse was considered progression. Relapse following complete remission(CR) is defined as reappearance of leukemic blasts in the peripheral blood or the finding of more than 5% blasts in the BM, not attributable to another cause (eg, BM regeneration after consolidation therapy) or extramedullary relapse.

Time frame
2 years]

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Navy General Hospital, Beijing

Lead sponsor

Source ClinicalTrials.gov

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