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Trial Title:
XPO-1 in Combination With RCHOP for DH/TH Lymphoma
NCT ID:
NCT05974085
Condition:
Double Hit Lymphoma
Triple Hit Lymphoma
Conditions: Official terms:
Lymphoma
Conditions: Keywords:
Double/Triple Hit Lymphoma
Selinexor
RCHOP
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Selinexor+RCHOP
Description:
XPO-1 inhibitor selinexor in combination with RCHOP
Arm group label:
Selinexor+RCHOP
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Volunteer to participate in clinical studies
2. Age: 18~75 (inclusive), male and female.
3. Histopathologically confirmed high-grade B-cell lymphoma with MYC and BCL2 and/or
BCL6 gene rearrangement.
4. No previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor therapy.
5. ECOG score is 0-2.
6. there must be at least one evaluable or measurable lesion that meets Lugano2014
criteria.
7. Adequate organ and bone marrow function.
8. Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination.
9. Serum pregnancy test negative
Exclusion Criteria:
1. 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.
2. known central nervous system involvement.
3. received prior anti-tumor therapy
4. 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
5. Had other malignant tumors in the past 5 years
6. Major surgery was performed within 28 days prior to study initiation
7. Cardiovascular function is unstable
8. Active infection
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310005
Country:
China
Status:
Recruiting
Contact:
Last name:
Cong Li, doctor
Phone:
15267115611
Email:
licong@zjcc.org.cn
Contact backup:
Last name:
Haiyan Yang, doctor
Phone:
0571-88122192
Email:
yanghy@zjcc.org.cn
Start date:
August 1, 2022
Completion date:
March 1, 2024
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05974085
