DLBCLPhase 1/2NCT05498636
SPEL as Introductive Treatment Following Immune-chemotherapy as Consolidated Therapy for R/R DLBCL With p53 and/or c-Myc Expression
A Phase 1/2 study testing Selinexor combined with Prednisone, Etoposide, and Lenalidomide in people with DLBCL, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
This study is a phase II multi-center prospective clinical trail which investigates the efficacy and safety of Selinexor combined with prednisone, etoposide and lenalidomide in the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patient with high p53 and/or c-myc expression. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- DLBCL
- What is being tested?
- Selinexor combined with Prednisone, Etoposide, and Lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 31 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any of the following as defined by the WHO, 2016 lymphoid neoplasm classifications and histologically confirmed：Diffuse large B-cell lymphoma with p53 and/ or c-Myc protein overexpression.
- Note: a. The cutoff value for p53 protein overexpression by immunohistochemistry (IHC) is 50%; cutoff value for c-Myc protein overexpression is 30-40%; b. For patients with high expression of C-Myc, dual-color FISH probes detection method should be used to check whether there is Myc and BCL2 gene rearrangement, which is cut by 5%; c. We need 5-10 pathological white films with a thickness of 5-10 um for review.
- Patients who cannot tolerate or are unwilling to undergo intensive salvage therapy due to age or frailty; patients who have received at most three prior lines of regimen, in which stem cell transplantation is considered first-line.
- With a life expectancy of ≥ 3 months
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
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- At least 1 evaluable or measurable lesion that meets Lugano2014 criteria [Evaluable lesions: PET/CT examination showed increased uptake in lymph nodes or extranodal areas (higher than that in the liver), and pet/ct features were consistent with lymphoma. Measurable disease: Nodular lesions with longest diameter (LDi) greater than > 15mm or extranodal lesion with LDi >10mm. and FDG-PET positive lesions]
- All screening laboratory tests should be performed according to the protocol and within 14 days before enrollment. Screening laboratory values must meet the following criteria： Routine blood tests (no blood transfusion, no G-CSF, no drug correction within 14 days before screening) : a. Hb≥80g/L；b.ANC≥1.0×109/L；c.PLT≥75×109/L.
- Blood biochemistry: a.TBIL≤1.5×upper limit of normal (ULN), or TBIL≤3×ULN(if due to liver involvement); b. ALT and AST≤3×ULN, or AST and ALT≤5.0 x ULN(if due to liver involvement); c. Serum creatinine ≤1.5×ULN, or Estimated creatinine clearance ≥ 50 mL/min (calculated using the formula of Cockcroft-Gault).
- Coagulation function (unless the subject is receiving anticoagulant treatment and the coagulation parameters (PT/INR and APTT) are within the expected range of anticoagulant treatment at the time of screening): INR≤1.5×ULN; APTT≤1.5×ULN.
- Written informed consent of the patient
Who cannot join
- Patient with hemophagocytic syndrome
- With uncontrolled serious active infections, including active tuberculosis
- Known to have central nervous system (CNS), testicular, breast lymphoma; Patients with massive pleural and peritoneal effusion
- Previous treatment with Selinexor or lenalidomide in the past 6 months
- Previous treatment with allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation.
- Autologous hematopoietic stem cell transplantation was performed within 6 months prior to initiation of treatment.
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- Major surgery <28 days of C1D1.
- Live vaccine (excluding attenuated influenza vaccine) within 28 days before study treatment.
- Ongoing participation in another clinical study, or planned initiation of treatment in this study less than 4 weeks from the end of treatment in the previous clinical study.
- Patients with serious medical diseases, such as organic heart disease, resulting in clinical symptoms or cardiac dysfunction (≥NYHA grade 2), a history of myocardial infarction within 6 months prior to screening, echocardiographic ejection fraction < 50%, and severe thromboembolic diseases.
- Positive HIV serologies before inclusion.
- Other malignant tumors in the past 5 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, and gastrointestinal intramucosal carcinoma after radical treatment.
- Additional systemic antitumor therapy may be accepted during the study period.
- Other conditions that patients considered unsuitable for inclusion by the researchers.
Trial locations and contacts
1 site in 1 country.
China1 site
the affiliated hospital of Qingdao University
Qingdao, Shandong, 266000
Hongwei Xue, doctor, 13475875599, hwx326@sina.com
Yawen Wang, doctor, 18661801601, wangyawang09@163.com
About this study
Official title: Selinexor Combined With Prednisone, Etoposide, and Lenalidomide as Introductive Treatment Following Immune-chemotherapy as Consolidated Therapy for Refractory Diffuse Large B-cell Lymphoma With p53 and/or c-Myc Expression
This study is a phase II multi-center prospective clinical trail which investigates the efficacy and safety of Selinexor combined with prednisone, etoposide and lenalidomide in the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patient with high p53 and/or c-myc expression.
- Conditions
- DLBCL
- Being tested
- Selinexor combined with Prednisone, Etoposide, and Lenalidomide
- Keywords
- DLBCL, p53, c-myc, selinexor, lenalidomide, refractory/relapse
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selinexor combined with Prednisone, Etoposide, and LenalidomideCombination product
Selinexor combined with Prednisone, Etoposide, and Lenalidomide
| Study group | Role | What they receive |
|---|---|---|
| SPEL | Experimental | Not described Receives: Combination Product: Selinexor combined with Prednisone, Etoposide, and Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR rate
complete remission rate after 4 cycles of SPEL regimen
Measured: At the end of Cycle 4 (each cycle is 28 days)
ORR
overall response rate after 4 cycles of SPEL regimen
Measured: At the end of Cycle 4 (each cycle is 28 days)
Secondary outcomes (1)
AE
adverse event of SPEL regimen
Measured: from the first dose of SPEL regimen to 3 months after last dose of the regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Oct 2022 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DLBCLStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498636
- Sponsor's protocol ID
- 202201
- Status last verified
- Aug 2022
- First submitted
- 3 Aug 2022
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selinexor Combined With Prednisone, Etoposide, and Lenalidomide as Introductive Treatment Following Immune-chemotherapy as Consolidated Therapy for Refractory Diffuse Large B-cell Lymphoma With p53 and/or c-Myc Expression
- ClinicalTrials.gov ID
- NCT05498636
- Acronym / sponsor ID
- 202201
- Conditions
- DLBCL
- Keywords
- DLBCL, p53, c-myc, selinexor, lenalidomide, refractory/relapse
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Aug 2022 (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.
This study is a phase II multi-center prospective clinical trail which investigates the efficacy and safety of Selinexor combined with prednisone, etoposide and lenalidomide in the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patient with high p53 and/or c-myc expression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPEL | Experimental | Combination Product: Selinexor combined with Prednisone, Etoposide, and Lenalidomide |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Any of the following as defined by the WHO, 2016 lymphoid neoplasm classifications and histologically confirmed：Diffuse large B-cell lymphoma with p53 and/ or c-Myc protein overexpression.
- Note: a. The cutoff value for p53 protein overexpression by immunohistochemistry (IHC) is 50%; cutoff value for c-Myc protein overexpression is 30-40%; b. For patients with high expression of C-Myc, dual-color FISH probes detection method should be used to check whether there is Myc and BCL2 gene rearrangement, which is cut by 5%; c. We need 5-10 pathological white films with a thickness of 5-10 um for review.
- Patients who cannot tolerate or are unwilling to undergo intensive salvage therapy due to age or frailty; patients who have received at most three prior lines of regimen, in which stem cell transplantation is considered first-line.
- With a life expectancy of ≥ 3 months
- Age ≥ 18 years
Key exclusion criteria (14 listed)
- Patient with hemophagocytic syndrome
- With uncontrolled serious active infections, including active tuberculosis
- Known to have central nervous system (CNS), testicular, breast lymphoma; Patients with massive pleural and peritoneal effusion
- Previous treatment with Selinexor or lenalidomide in the past 6 months
- Previous treatment with allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation.
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 Prednisone, Etoposide, and LenalidomideSelinexor combined with Prednisone, Etoposide, and Lenalidomide | Combination product | SPEL |
Primary outcome
CR rate
Time frame: At the end of Cycle 4 (each cycle is 28 days)
complete remission rate after 4 cycles of SPEL regimen
ORR
Time frame: At the end of Cycle 4 (each cycle is 28 days)
overall response rate after 4 cycles of SPEL regimen
1 secondary outcome
AE
Time frame: from the first dose of SPEL regimen to 3 months after last dose of the regimen
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Selinexor combined with Prednisone, Etoposide, and Lenalidomide in people with DLBCL, run by The Affiliated Hospital of Qingdao University at 1 site in China.
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 11 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongwei Xue, doctor (+8613475875599, hwx326@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CR rate (time frame: At the end of Cycle 4 (each cycle is 28 days)). The study lists 2 primary outcomes in all. 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 19 Aug 2022.