XPO-1 in Combination With RCHOP for DH/TH Lymphoma

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Primary Purpose

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Selinexor+RCHOP

About this trial

This is an interventional treatment trial for Double Hit Lymphoma focused on measuring Double/Triple Hit Lymphoma, Selinexor, RCHOP

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Volunteer to participate in clinical studies Age: 18~75 (inclusive), male and female. Histopathologically confirmed high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 gene rearrangement. No previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor therapy. ECOG score is 0-2. there must be at least one evaluable or measurable lesion that meets Lugano2014 criteria. Adequate organ and bone marrow function. Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination. Serum pregnancy test negative Exclusion Criteria: Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination. 1) Mixed lymphoma (Hodgkin's lymphoma + non-Hodgkin's lymphoma), or DLBCL transformed from inert non-Hodgkin's lymphoma, or gray zone lymphoma (lymphoma between DLBCL and Hodgkin's lymphoma), or inert lymphoma with MYC, BCL2, BCL6 gene rearrangement. known central nervous system involvement. received prior anti-tumor therapy Is participating in another clinical study or is receiving the first investigational drug less than 4 weeks after the completion of treatment in the previous clinical study Had other malignant tumors in the past 5 years Major surgery was performed within 28 days prior to study initiation Cardiovascular function is unstable Active infection

Sites / Locations

Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Selinexor+RCHOP

Arm Description

Selinexor: 60 mg QW Rituximab: 375 mg/m2, d0 Vincristine: 4 mg, d1 Epirubicin: 75 mg/m2, d1 or Liposomal doxorubicin: 35 mg/m2, d1 Cyclophosphamide: 750 mg/m2, d1 Prednisone: 100 mg, d1-5

Outcomes

Primary Outcome Measures

Objective Response Rate

CR plus PR

Secondary Outcome Measures

PFS

Progression Free Survival

OS

Overall Survival

AE and SAE

Adverse event and serious adverse event

Full Information

NCT ID

NCT05974085

First Posted

January 13, 2022

Last Updated

August 2, 2023

Sponsor

Zhejiang Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05974085

Brief Title

XPO-1 in Combination With RCHOP for DH/TH Lymphoma

Official Title

Prospective, Single-arm, Single-center, Phase II Clinical Study of XPO-1 Inhibitor Selinexor in Combination With RCHOP Regimen in the Treatment of Double Hit/Triple Hit B Cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

Brief Summary

The purpose of this study was to evaluate the efficacy and safety of Selinexor in combination with RCHOP in first-line treatment of patients with DH or TH lymphoma.

Detailed Description

This is a prospective, single-arm, single-center clinical study evaluating the first-line treatment of DH or TH lymphoma with Selinexor combined with RCHOP. There are three stages: screening, treatment and follow-up period. The screening period was 28 days before the first dose. Treatment period: Enrolled subjects were treated with Selinexor in combination with RCHOP every 21 days for a maximum of 6 cycles until the efficacy of SD or PD, drug toxicity became intolerable, subject withdrawal of consent, death, or continuation of chemotherapy deemed unsuitable by the investigator. Lugano2014 criteria were used to evaluate the efficacy during treatment. Objective effective rate, safety and survival data were observed during the experiment. After stopping treatment or completing 6 cycles of treatment, subjects entered the follow-up period, during which imaging evaluation (enhanced CT at focal site is recommended) was performed at the following intervals: once every 3 months for 2 years, once every 6 months for 3-5 years, and once every 5 years until the end of the follow-up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Double Hit Lymphoma, Triple Hit Lymphoma

Keywords

Double/Triple Hit Lymphoma, Selinexor, RCHOP

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Selinexor+RCHOP

Arm Type

Experimental

Arm Description

Selinexor: 60 mg QW Rituximab: 375 mg/m2, d0 Vincristine: 4 mg, d1 Epirubicin: 75 mg/m2, d1 or Liposomal doxorubicin: 35 mg/m2, d1 Cyclophosphamide: 750 mg/m2, d1 Prednisone: 100 mg, d1-5

Intervention Type

Drug

Intervention Name(s)

Selinexor+RCHOP

Intervention Description

XPO-1 inhibitor selinexor in combination with RCHOP

Primary Outcome Measure Information:

Title

Objective Response Rate

Description

CR plus PR

Time Frame

From date of first day of treatment until the date of last day of treatment

Secondary Outcome Measure Information:

Title

PFS

Description

Progression Free Survival

Time Frame

From date of first day of treatmentuntil the date of first documented progression, assessed up to 24 months

Title

OS

Description

Overall Survival

Time Frame

From date of first day of treatmentuntil the date of first documented date of death from any cause, assessed up to 24 months

Title

AE and SAE

Description

Adverse event and serious adverse event

Time Frame

From date of first day of treatmentuntil 30 day after last treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Volunteer to participate in clinical studies Age: 18~75 (inclusive), male and female. Histopathologically confirmed high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 gene rearrangement. No previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor therapy. ECOG score is 0-2. there must be at least one evaluable or measurable lesion that meets Lugano2014 criteria. Adequate organ and bone marrow function. Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination. Serum pregnancy test negative Exclusion Criteria: Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination. 1) Mixed lymphoma (Hodgkin's lymphoma + non-Hodgkin's lymphoma), or DLBCL transformed from inert non-Hodgkin's lymphoma, or gray zone lymphoma (lymphoma between DLBCL and Hodgkin's lymphoma), or inert lymphoma with MYC, BCL2, BCL6 gene rearrangement. known central nervous system involvement. received prior anti-tumor therapy Is participating in another clinical study or is receiving the first investigational drug less than 4 weeks after the completion of treatment in the previous clinical study Had other malignant tumors in the past 5 years Major surgery was performed within 28 days prior to study initiation Cardiovascular function is unstable Active infection

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cong Li

Phone

15267115611

Email

licong@zjcc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cong Li

Organizational Affiliation

Zhejiang Cancer Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhejiang Cancer Hospital

City

Hangzhou

State/Province

Zhenjiang

ZIP/Postal Code

310005

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cong Li, doctor

Phone

15267115611

Email

licong@zjcc.org.cn

First Name & Middle Initial & Last Name & Degree

Haiyan Yang, doctor

Phone

0571-88122192

Email

yanghy@zjcc.org.cn

12. IPD Sharing Statement

Plan to Share IPD

No

Double Hit Lymphoma, Triple Hit Lymphoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial