Diffuse Large B Cell Lymphoma study: R-CHOP Protocol
Official title Selinexor in Combination With R-CHOP as the First-line Therapy for TP53-mutated DLBCL Patients (Smart Trial)
ClinicalTrials.gov ID: NCT06517511
What this study is testing
What is Selinexor Oral Tablet [Xpovio]?
Selinexor Oral Tablet [Xpovio] is an investigational medicine, taken by mouth, being studied as a potential treatment for diffuse large b cell lymphoma.
Also referred to as exportin 1 (XPO1) inhibitor.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-arm, multi-center, phase II clinical trial to look at how well it works and how safe it is of selinexor in combination with R-CHOP (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone) followed by selinexor maintenance for untreated TP53-mutated diffuse large B-cell lymphoma (DLBCL) patients.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- people fully understand and voluntarily participate in this study and sign informed consent.
- Aged ≥18 and ≤80 years, no gender limitation.
- Histologically confirmed DLBCL with TP53 mutations (allowing transformed or concurrent indolent B-cell non-Hodgkin lymphoma)
- No prior systemic anti-lymphoma therapy; prior local radiotherapy alone is permitted.
- There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
You likely can't join if
- DLBCL with Hodgkin lymphoma, T-cell lymphoma, or other non-B-cell lymphoma; Richter transformation.
- DLBCL with central nervous system invasion.
- The patients had previously received XPO1 inhibitors.
- The patients have contraindications to any drug in the combined treatment.
- Patients with chronic active hepatitis B or active hepatitis C. If the background hepatitis B surface antigen (HBsAg) and/or hepatitis B core...
- Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
See the full eligibility criteria
- people fully understand and voluntarily participate in this study and sign informed consent.
- Aged ≥18 and ≤80 years, no gender limitation.
- Histologically confirmed DLBCL with TP53 mutations (allowing transformed or concurrent indolent B-cell non-Hodgkin lymphoma)
- No prior systemic anti-lymphoma therapy; prior local radiotherapy alone is permitted.
- There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2.
- Expected survival ≥ 3 months.
- Adequate function of bone marrow, liver, and kidney.
- DLBCL with Hodgkin lymphoma, T-cell lymphoma, or other non-B-cell lymphoma; Richter transformation.
- DLBCL with central nervous system invasion.
- The patients had previously received XPO1 inhibitors.
- The patients have contraindications to any drug in the combined treatment.
- Patients with chronic active hepatitis B or active hepatitis C. If the background hepatitis B surface antigen (HBsAg) and/or hepatitis B core Antibody (HBcAb) or hepatitis C Virus (HCV) antibody are positive, the...
- Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
- Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug.
- Pregnant and lactating women and people of childbearing age who do not want to use contraception.
- Mentally ill persons or persons unable to obtain informed consent.
- Any condition deemed unsuitable by the investigator.
The study team makes the final eligibility decision.
Where it is enrolling
- Guangzhou, Guangdong, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Guangzhou, Guangdong, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.