Zanubrutinib Combined With BEAM for ASCT in Relapsed and Refractory DLBCL

NCT06652165 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: ASCT-003
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial is a prospective, single-center, randomized controlled clinical research. The intention is to evaluate the efficacy and safety of zanubrutinib combined with BEAM as a pretreatment regimen for ASCT in relapsed and refractory DLBCL patients through prospective clinical studies.

Conditions

DLBCL

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

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

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

Secondary Outcomes (4)

• Overall survival

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

Study Arms (2)

zanubrutinib combined with BEAM

EXPERIMENTAL

zanubrutinib combined with camustine, etoposide, cytarabine, and mafaran (BEAM)

Drug: zanubrutinib combined with BEAM

BEAM

ACTIVE COMPARATOR

camustine, etoposide, cytarabine, and mafaran (BEAM)

Drug: BEAM

Interventions

zanubrutinib combined with BEAM DRUG

zanubrutinib：160mg oral bid D-8-D-2 camustine: 300mg/m2 vgtt qd D-8 etoposide: 100mg/m2/d vgtt q12h D-7-D-4 cytarabine: 200mg/m2/d vgtt q12h D-7-D-4 melphalan: 140mg/m2 vgtt qd D3-D-2

zanubrutinib combined with BEAM

BEAM DRUG

camustine: 300mg/m2 vgtt qd D-8 etoposide: 100mg/m2/d vgtt q12h D-7-D-4 cytarabine: 200mg/m2/d vgtt q12h D-7-D-4 melphalan: 140mg/m2 vgtt qd D3-D-2

BEAM

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;
• ≤ 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

Central Study Contacts

Wei-Li Zhao, professor

CONTACT

+862164370045; zwl_trial@163.com

Meng-Meng Ji, doctor

CONTACT

+862164370045; jimengmeng025@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: 2024-08

Data Sharing

• IPD Sharing: Will not share