Double Hit LymphomaPhase 2NCT05974085
XPO-1 in Combination With RCHOP for DH/TH Lymphoma
A Phase 2 study testing Selinexor+RCHOP in people with Double Hit Lymphoma and Triple Hit Lymphoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
The purpose of this study was to evaluate the efficacy and safety of Selinexor in combination with RCHOP in first-line treatment of patients with DH or TH lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Double Hit Lymphoma, Triple Hit Lymphoma
- What is being tested?
- Selinexor+RCHOP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 1 Mar 2024
- Phase
- Phase 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteer to participate in clinical studies
- Age: 18~75 (inclusive), male and female.
- Histopathologically confirmed high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 gene rearrangement.
- No previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor therapy.
- ECOG score is 0-2.
- there must be at least one evaluable or measurable lesion that meets Lugano2014 criteria.
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- Adequate organ and bone marrow function.
- Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination.
- Serum pregnancy test negative
Who cannot join
- Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination. 1) Mixed lymphoma (Hodgkin's lymphoma + non-Hodgkin's lymphoma), or DLBCL transformed from inert non-Hodgkin's lymphoma, or gray zone lymphoma (lymphoma between DLBCL and Hodgkin's lymphoma), or inert lymphoma with MYC, BCL2, BCL6 gene rearrangement.
- known central nervous system involvement.
- received prior anti-tumor therapy
- Is participating in another clinical study or is receiving the first investigational drug less than 4 weeks after the completion of treatment in the previous clinical study
- Had other malignant tumors in the past 5 years
- Major surgery was performed within 28 days prior to study initiation
- Cardiovascular function is unstable
- Active infection
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhenjiang, 310005
Cong Li, doctor, 15267115611, licong@zjcc.org.cn
Haiyan Yang, doctor, 0571-88122192, yanghy@zjcc.org.cn
About this study
Official title: Prospective, Single-arm, Single-center, Phase II Clinical Study of XPO-1 Inhibitor Selinexor in Combination With RCHOP Regimen in the Treatment of Double Hit/Triple Hit B Cell Lymphoma
The purpose of this study was to evaluate the efficacy and safety of Selinexor in combination with RCHOP in first-line treatment of patients with DH or TH lymphoma.
Read the detailed description
This is a prospective, single-arm, single-center clinical study evaluating the first-line treatment of DH or TH lymphoma with Selinexor combined with RCHOP. There are three stages: screening, treatment and follow-up period. The screening period was 28 days before the first dose. Treatment period: Enrolled subjects were treated with Selinexor in combination with RCHOP every 21 days for a maximum of 6 cycles until the efficacy of SD or PD, drug toxicity became intolerable, subject withdrawal of consent, death, or continuation of chemotherapy deemed unsuitable by the investigator. Lugano2014 criteria were used to evaluate the efficacy during treatment. Objective effective rate, safety and survival data were observed during the experiment. After stopping treatment or completing 6 cycles of treatment, subjects entered the follow-up period, during which imaging evaluation (enhanced CT at focal site is recommended) was performed at the following intervals: once every 3 months for 2 years, once every 6 months for 3-5 years, and once every 5 years until the end of the follow-up period.
- Conditions
- Double Hit Lymphoma, Triple Hit Lymphoma
- Being tested
- Selinexor+RCHOP
- Keywords
- Double/Triple Hit Lymphoma, Selinexor, RCHOP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selinexor+RCHOPDrug
XPO-1 inhibitor selinexor in combination with RCHOP
| Study group | Role | What they receive |
|---|---|---|
| Selinexor+RCHOP | Experimental | Selinexor: 60 mg QW Rituximab: 375 mg/m2, d0 Vincristine: 4 mg, d1 Epirubicin: 75 mg/m2, d1 or Liposomal doxorubicin: 35 mg/m2, d1 Cyclophosphamide: 750 mg/m2, d1 Prednisone: 100 mg, d1-5 Receives: Drug: Selinexor+RCHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
CR plus PR
Measured: From date of first day of treatment until the date of last day of treatment
Secondary outcomes (3)
PFS
Progression Free Survival
Measured: From date of first day of treatmentuntil the date of first documented progression, assessed up to 24 months
OS
Overall Survival
Measured: From date of first day of treatmentuntil the date of first documented date of death from any cause, assessed up to 24 months
AE and SAE
Adverse event and serious adverse event
Measured: From date of first day of treatmentuntil 30 day after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start1 Aug 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Double Hit LymphomaStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang haiyan, Zhejiang Cancer Hospital
- Investigators
- Cong Li, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974085
- Sponsor's protocol ID
- XRCHOP
- Status last verified
- Aug 2023
- First submitted
- 13 Jan 2022
- Last updated
- 3 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li C, Chen X, Xu J, Lei T, Yu H, Peng S, Han S, Yang H. Selinexor Combined With R-CHOP Achieved a High Response Rate in Newly Diagnosed Double/Triple Hit Lymphoma. Blood Adv. 2026 Jul 21:bloodadvances.2025018580. doi: 10.1182/bloodadvances.2025018580. Online ahead of print.
PubMed 42480213
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-arm, Single-center, Phase II Clinical Study of XPO-1 Inhibitor Selinexor in Combination With RCHOP Regimen in the Treatment of Double Hit/Triple Hit B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT05974085
- Acronym / sponsor ID
- XRCHOP
- Conditions
- Double Hit Lymphoma, Triple Hit Lymphoma
- Keywords
- Double/Triple Hit Lymphoma, Selinexor, RCHOP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 3 Aug 2023 (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.
The purpose of this study was to evaluate the efficacy and safety of Selinexor in combination with RCHOP in first-line treatment of patients with DH or TH lymphoma.
Detailed description
This is a prospective, single-arm, single-center clinical study evaluating the first-line treatment of DH or TH lymphoma with Selinexor combined with RCHOP. There are three stages: screening, treatment and follow-up period. The screening period was 28 days before the first dose. Treatment period: Enrolled subjects were treated with Selinexor in combination with RCHOP every 21 days for a maximum of 6 cycles until the efficacy of SD or PD, drug toxicity became intolerable, subject withdrawal of consent, death, or continuation of chemotherapy deemed unsuitable by the investigator. Lugano2014 criteria were used to evaluate the efficacy during treatment. Objective effective rate, safety and survival data were observed during the experiment. After stopping treatment or completing 6 cycles of treatment, subjects entered the follow-up period, during which imaging evaluation (enhanced CT at focal site is recommended) was performed at the following intervals: once every 3 months for 2 years, once every 6 months for 3-5 years, and once every 5 years until the end of the follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Selinexor+RCHOP | Experimental | Drug: Selinexor+RCHOPSelinexor: 60 mg QW Rituximab: 375 mg/m2, d0 Vincristine: 4 mg, d1 Epirubicin: 75 mg/m2, d1 or Liposomal doxorubicin: 35 mg/m2, d1 Cyclophosphamide: 750 mg/m2, d1 Prednisone: 100 mg, d1-5 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Volunteer to participate in clinical studies
- Age: 18~75 (inclusive), male and female.
- Histopathologically confirmed high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 gene rearrangement.
- No previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor therapy.
- ECOG score is 0-2.
Key exclusion criteria (8 listed)
- Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination. 1) Mixed lymphoma (Hodgkin's lymphoma + non-Hodgkin's lymphoma), or DLBCL transformed from inert non-Hodgkin's lymphoma, or gray zone lymphoma (lymphoma between DLBCL and Hodgkin's lymphoma), or inert lymphoma with MYC, BCL2, BCL6 gene rearrangement.
- known central nervous system involvement.
- received prior anti-tumor therapy
- Is participating in another clinical study or is receiving the first investigational drug less than 4 weeks after the completion of treatment in the previous clinical study
- Had other malignant tumors in the past 5 years
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+RCHOPXPO-1 inhibitor selinexor in combination with RCHOP | Drug | Selinexor+RCHOP |
Primary outcome
Objective Response Rate
Time frame: From date of first day of treatment until the date of last day of treatment
CR plus PR
3 secondary outcomes
PFS
Time frame: From date of first day of treatmentuntil the date of first documented progression, assessed up to 24 months
OS
Time frame: From date of first day of treatmentuntil the date of first documented date of death from any cause, assessed up to 24 months
AE and SAE
Time frame: From date of first day of treatmentuntil 30 day after last treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Derived from this study: PubMed 42480213Li C, Chen X, Xu J, Lei T, Yu H, Peng S, Han S, Yang H. Selinexor Combined With R-CHOP Achieved a High Response Rate in Newly Diagnosed Double/Triple Hit Lymphoma. Blood Adv. 2026 Jul 21:bloodadvances.2025018580. doi: 10.1182/bloodadvances.2025018580. Online ahead of print.
- 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.
Cong Li principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Selinexor+RCHOP in people with Double Hit Lymphoma and Triple Hit Lymphoma, run by Zhejiang Cancer Hospital 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 9 inclusion and 8 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 3 Aug 2023. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cong Li (15267115611, licong@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: From date of first day of treatment until the date of last day of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05974085, which also lists 1 linked publication.
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 3 Aug 2023.