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Selinexor Plus R-CHOP in High-risk GCB-subtype Diffuse Large B-Cell Lymphoma

ConditionDLBCL Germinal Center B-Cell Type
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLi Zhiming

About this trial

This is a phase II, multicenter, single-arm and open-label study to explore Selinexor in combination with standard of care R-CHOP in New Diagnosed high-risk GCB-subtype DLBCL (IPI 3-5). Approximately 35 patients plan to be enrolled in about 6-8 study sites of the study. And the objective is to Evaluate the safety and efficacy of XR-CHOP in High-Risk (IPI 3-5) GCB-subtype DLBCL.The enrollment period for this study is expected to be approximately 18 months. The study will end when all patients have completed 6 cycles treatment/follow-up since the initiation of the study drug, or the last patient has expired, has been lost to follow-up, or has withdrawn consent, whichever occurs first.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Willing and able to written informed consent (ICF) .

Age ≥ 18 years and ≤ 75 years.

Histologically confirmed Diffuse Large B-Cell Lymphoma of the germinal center B-cell(DLBCL) subtype by Hans.

Patients no prior chemotherapy or radiotherapy for DLBCL, with the exception of no more than 5 days of treatment with glucocorticoids for symptom control.

Disqualifiers

Willing and able to written informed consent (ICF) .

Age ≥ 18 years and ≤ 75 years.

Histologically confirmed Diffuse Large B-Cell Lymphoma of the germinal center B-cell(DLBCL) subtype by Hans.

Patients no prior chemotherapy or radiotherapy for DLBCL, with the exception of no more than 5 days of treatment with glucocorticoids for symptom control.

Trial design

Design model

Single group

Treatments tested in this trial

  • Selinexor

    Drug

    Selinexor (ATG-010# is a first-in-class, oral selective exportin 1 (XPO1) inhibitor (1,2). Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus along with inhibition of translation of oncoprotein mRNAs. Selinexor 60mg on day 1,8,15 for 21 days cycles

  • Rituximab

    Drug

    Induction Chemotherapy: 375mg/sqm, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease, up to 6 cycles.

  • Cyclophosphamide

    Drug

    Induction Chemotherapy: 750mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease, up to 6 cycles.

  • Doxorubicin

    Drug

    Induction Chemotherapy: 70mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease, up to 6 cycles.

  • Vincristine

    Drug

    Induction Chemotherapy: 1.4mg/m2 (Max: 2mg), Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease, up to 6 cycles.

  • Prednisone

    Drug

    Induction Chemotherapy: 100mg, oral administration on day 1 to 5 of each 3-week cycle until disease progression/stable disease, up to 6 cycles.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Selinexor-R-CHOPExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Complete Response Rate (CR)

Complete Remission (CR) rate at any time up of cycle 6 defined by Lugano 2014 defined response. Number of patients who achieved complete response after treatment by XR-CHOP

Time frame
up to 18 months

Secondary outcomes

1

Overall Response Rate (ORR)

Overall Response Rate (ORR) per the Lugano Classification 2014 \[ Time Frame: Cycle 1 Day 1 (each cycle consists of maximum 21 days) until a complete response (CR) or partial response (PR)

Time frame
up to 18 months
2

Progression Free Survival(PFS)

Duration from start of study treatment to Progressive disease(PD) or death (regardless of cause), whichever comes first.

Time frame
up to 18 months
3

Disease free survival(DFS)

To assess only the population with the best response to CR, Duration from patients who achieve CR or better time to first occurrence of PD or death(regardless of cause),whichever comes first.

Time frame
up to 18 months
4

Overall survival(OS)

Duration from start of study treatment to death (regardless of cause).

Time frame
up to 18 months

Other outcomes

Sponsors and contacts

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

Li Zhiming

Lead sponsor

Sun Yat-sen University

Sponsor institution

Antengene Corporation

Collaborator

Source ClinicalTrials.gov
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