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

University of Chinese Academy Sciences

Status and phase: Enrolling; Phase 2

Conditions: Triple Hit Lymphoma; Double Hit Lymphoma

Treatments: Drug: Selinexor+RCHOP

Study type: Interventional

Funder types: Other

Identifiers

NCT05974085

XRCHOP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Selinexor+RCHOP

Experimental group

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

Treatment:

Drug: Selinexor+RCHOP