UnknownPhase 1/2

SPEL as Introductive Treatment Following Immune-chemotherapy as Consolidated Therapy for R/R DLBCL With p53 and/or c-Myc Expression

China67 participantsStarted 2022-10-01

Plain-language 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.

Who can participate

Age range

16 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. 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
. At least 1 evaluable or measurable lesion that meets Lugano2014 criteria \[Evaluable lesions: PET/CT examination showed increased uptake in lymph nodes or extranodal areas (higher than that in the liver), and pet/ct features were consistent with lymphoma. Measurable disease: Nodular lesions with longest diameter (LDi) greater than \> 15mm or extranodal lesion with LDi \>10mm. and FDG-PET positive lesions\]

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

CR rate

Timeframe: At the end of Cycle 4 (each cycle is 28 days)

ORR

Timeframe: At the end of Cycle 4 (each cycle is 28 days)

Trial details

NCT IDNCT05498636

SponsorThe Affiliated Hospital of Qingdao University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-30

Contact for this trial

Hongwei Xue, doctor

+8613475875599 hwx326@sina.com

View on ClinicalTrials.gov More DLBCL trials

Who can participate

Age range

16 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. 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
. At least 1 evaluable or measurable lesion that meets Lugano2014 criteria \[Evaluable lesions: PET/CT examination showed increased uptake in lymph nodes or extranodal areas (higher than that in the liver), and pet/ct features were consistent with lymphoma. Measurable disease: Nodular lesions with longest diameter (LDi) greater than \> 15mm or extranodal lesion with LDi \>10mm. and FDG-PET positive lesions\]

SPEL as Introductive Treatment Following Immune-chemotherapy as Consolidated Therapy for R/R DLBCL With p53 and/or c-Myc Expression

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

SPEL as Introductive Treatment Following Immune-chemotherapy as Consolidated Therapy for R/R DLBCL With p53 and/or c-Myc Expression

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria