Selinexor Combined With BEAM for ASCT in R/R DLBCL With MYC Positive

NCT06652139 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: SINE+BEAM
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the efficacy and safety of selinexor combined with BEAM pretreatment regimen in ASCT of recurrent and refractory DLBCL patients with immunohistochemical positive for MYC

Conditions

Diffuse Large B Cell Lymphoma

Keywords

Diffuse large B cell lymphoma; Autologous stem cell transplantation; Selinexor; BEAM

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Progression-free survival was defined as the time from the date of ASCT until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from an cause, whichever occurred first.

  Baseline up to data cut-off (up to approximately 2 years)

Secondary Outcomes (4)

• Overall survival

  Baseline up to data cut-off (up to approximately 2 years)

• Complete remission rate

  3 months after the transplantation

• The time of hematopoietic reconstruction

  2 months after the transplantation

• Transplantation-related adverse reactions

  Baseline up to data cut-off (up to approximately 4 years)

Study Arms (2)

selinexor combined with BEAM pretreatment regimen

EXPERIMENTAL

Patients in this arm will receive selinexor combined with BEAM (carmustine, etoposide, cytarabine and melphalan) as pretreatment regimen of ASCT.

Drug: selinexor combined with BEAM regimen

BEAM pretreatment regimen

ACTIVE COMPARATOR

Patients in this arm will receive BEAM (carmustine, etoposide, cytarabine and melphalan) as pretreatment regimen of ASCT.

Drug: BEAM regimen

Interventions

selinexor combined with BEAM regimen DRUG

Selinexor: 60mg po D-10, D-7 and D-4 Carmustine: 300mg/m2 ivgtt D-8 Etoposide: 100mg/m2/d ivgtt q12h D-7-D-4 Cytarabine: 200mg/m2/d ivgtt q12h D-7-D-4 Melphalan: 140mg/m2 ivgtt D-3-D2

Also known as: SINE+BEAM

selinexor combined with BEAM pretreatment regimen

BEAM regimen DRUG

Carmustine: 300mg/m2 ivgtt D-8 Etoposide: 100mg/m2/d ivgtt q12h D-7-D-4 Cytarabine: 200mg/m2/d ivgtt q12h D-7-D-4 Melphalan: 140mg/m2 ivgtt D-3-D2

Also known as: BEAM

BEAM pretreatment regimen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• According to world Health Organization (WHO) classification of disease, diffuse large B-cell lymphoma was confirmed by histology, CR or PR after second-line and above treatment;
• The subjects tested positive for MYC in primary or pre-transplant lymphoma lesions;
• ≤ age ≤65 years old, male or female;
• ECOG score 0-2;
• No serious organic lesions in the main organs, meeting the requirements of the following laboratory examination indicators (conducted within 7 days before treatment) :
• White blood cell count ≥3.0×109/L, absolute neutrophil count ≥1.5×109/L, Hemoglobin ≥90g/L, platelet ≥75×109/L;
• Total bilirubin ≤1.5× upper normal value (ULN);
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN; Bilirubin ≤1.5× ULN
• Creatinine clearance was 44-133 mmol/L;
• No cardiac dysfunction;
• Life expectancy over 3 months;
• The subject or his/her legal representative must provide written informed consent prior to conducting a special study examination or procedure.

You may not qualify if:

• Previously received autologous hematopoietic stem cell transplantation;
• Suffering from serious complications or severe infection;
• Previous treatment with selinexor;
• Central nervous system lymphoma was excluded;
• A history of other malignant tumors within 5 years, excluding early tumors treated for curative purposes;
• Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.;
• HBsAg, HCV or HIV positive. Positive HBV and HCV serology is allowed, but DNA/RNA testing must be negative;
• Left ventricular ejection fraction ≦ 50%;
• Laboratory test value during screening;
• ① Neutrophils \<1.5×109/L; Platelet \<75×109/L;
• ② Bilirubin was 1.5 times higher than the normal upper limit, transaminase was 2.5 times higher than the normal upper limit;
• ③ The creatinine level is higher than 1.5 times the upper limit of normal value;
• Other concurrent and uncontrolled medical conditions considered by the investigator would affect the patient's participation in the study;
• Psychiatric patients or other patients known or suspected to be unable to fully comply with the study protocol;
• Pregnant or lactating women;

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

BEAM regimen

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Zhao Weili, Professor

CONTACT

+862164370045; zwl_trial@163.com

Shen Yige, Professor

CONTACT

+862164370045; 13735204096@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 22, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2028
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share