Diffuse Large B Cell LymphomaPhase 2NCT06652139
Selinexor Combined With BEAM for ASCT in R/R DLBCL With MYC Positive
A Phase 2 study testing selinexor combined with BEAM regimen and BEAM regimen in people with Diffuse Large B Cell Lymphoma, run by Ruijin Hospital.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- selinexor combined with BEAM regimen and BEAM regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 Nov 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 18≤ 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;
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- 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.
Who cannot join
- 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.;
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- 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;
- The researcher judged that the patients were not suitable for this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-center, Randomized Controlled Clinical Study of Selinexor Combined With BEAM as a Preconditioning Regimen for ASCT in Relapsed and Refractory Diffuse Large B-cell Lymphoma With MYC Positive
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
Read the detailed description
This trial included 82 patients, who were randomly divided into pre-treatment with selinexor combined with BEAM regimen (experimental group) or BEAM regimen (control group) according to 1:1, and then underwent ASCT therapy. The trial included a screening period, a treatment period (2 weeks before and after transplantation), and a follow-up period (2 years after autologous transplantation). At 3, 6, 9 and 18 months after ASCT, blood routine, blood biochemistry, B-ultrasound of liver, bile, pancreas, spleen and lymph node, and whole body enhanced CT were performed. At 1 and 2 years after ASCT, blood routine, blood biochemistry, and whole body PET-CT evaluation were performed until the end of the study.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- selinexor combined with BEAM regimen, BEAM regimen
- Keywords
- Diffuse large B cell lymphoma, Autologous stem cell transplantation, Selinexor, BEAM
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selinexor combined with BEAM regimenDrug
Also called SINE+BEAM
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
BEAM regimenDrug
Also called BEAM
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: BEAM regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to data cut-off (up to approximately 2 years)
Secondary outcomes (4)
Overall survival
Overall survival was defined as the time from the date of ASCT to the date of death from any cause.
Measured: Baseline up to data cut-off (up to approximately 2 years)
Complete remission rate
Percentage of participants with complete response was determined on 2014 Lugano criteria.
Measured: 3 months after the transplantation
The time of hematopoietic reconstruction
The first day of neutrophils ≥0.5×109/L for 3 consecutive days was the time of successful implantation of granulocytes. Platelet ≥20.0×109/L for 7 consecutive days and the first day after platelet infusion was considered as the successful time of megakaryocytes implantation.
Measured: 2 months after the transplantation
Transplantation-related adverse reactions
Transplantation-related adverse reactions are any untoward medical occurrence in a participant which is related to ASCT.
Measured: Baseline up to data cut-off (up to approximately 4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652139
- Sponsor's protocol ID
- SINE+BEAM
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized Controlled Clinical Study of Selinexor Combined With BEAM as a Preconditioning Regimen for ASCT in Relapsed and Refractory Diffuse Large B-cell Lymphoma With MYC Positive
- ClinicalTrials.gov ID
- NCT06652139
- Acronym / sponsor ID
- SINE+BEAM
- Conditions
- Diffuse Large B Cell Lymphoma
- Keywords
- Diffuse large B cell lymphoma, Autologous stem cell transplantation, Selinexor, BEAM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This trial included 82 patients, who were randomly divided into pre-treatment with selinexor combined with BEAM regimen (experimental group) or BEAM regimen (control group) according to 1:1, and then underwent ASCT therapy. The trial included a screening period, a treatment period (2 weeks before and after transplantation), and a follow-up period (2 years after autologous transplantation). At 3, 6, 9 and 18 months after ASCT, blood routine, blood biochemistry, B-ultrasound of liver, bile, pancreas, spleen and lymph node, and whole body enhanced CT were performed. At 1 and 2 years after ASCT, blood routine, blood biochemistry, and whole body PET-CT evaluation were performed until the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| selinexor combined with BEAM pretreatment regimen | Experimental | Drug: selinexor combined with BEAM regimenPatients in this arm will receive selinexor combined with BEAM (carmustine, etoposide, cytarabine and melphalan) as pretreatment regimen of ASCT. |
| BEAM pretreatment regimen | Active comparator | Drug: BEAM regimenPatients in this arm will receive BEAM (carmustine, etoposide, cytarabine and melphalan) as pretreatment regimen of ASCT. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
- 18≤ 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) :
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| selinexor combined with BEAM regimenAlso: SINE+BEAMSelinexor: 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 | Drug | selinexor combined with BEAM pretreatment regimen |
| BEAM regimenAlso: BEAMCarmustine: 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 | Drug | BEAM pretreatment regimen |
Primary outcome
Progression free survival
Time frame: Baseline up to data cut-off (up to approximately 2 years)
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.
4 secondary outcomes
Overall survival
Time frame: Baseline up to data cut-off (up to approximately 2 years)
Complete remission rate
Time frame: 3 months after the transplantation
The time of hematopoietic reconstruction
Time frame: 2 months after the transplantation
Transplantation-related adverse reactions
Time frame: Baseline up to data cut-off (up to approximately 4 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing selinexor combined with BEAM regimen and BEAM regimen in people with Diffuse Large B Cell Lymphoma, run by Ruijin Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhao Weili, Professor (+862164370045, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: Baseline up to data cut-off (up to approximately 2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.