DLBCL Germinal Center B-Cell TypePhase 2NCT05422066
Selinexor Plus R-CHOP in High-risk GCB-subtype Diffuse Large B-Cell Lymphoma
A Phase 2 study testing Selinexor, Rituximab and Cyclophosphamide in people with DLBCL Germinal Center B-Cell Type, run by Li Zhiming at 6 sites in China.
Trial summary
This is a phase II, multicenter, single-arm and open-label study to explore Selinexor in combination with standard of care R-CHOP in New Diagnosed high-risk GCB-subtype DLBCL (IPI 3-5). Approximately 35 patients plan to be enrolled in about 6-8 study sites of the study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- DLBCL Germinal Center B-Cell Type
- What is being tested?
- Selinexor, Rituximab and Cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesChina
- Study dates
- 26 Jul 2022to 31 Dec 2025
- 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
- Patients must meet all of the following inclusion criteria to be eligible to enroll in this study:
- Willing and able to written informed consent (ICF) .
- Age ≥ 18 years and ≤ 75 years.
- Histologically confirmed Diffuse Large B-Cell Lymphoma of the germinal center B-cell(DLBCL) subtype by Hans.
- Patients no prior chemotherapy or radiotherapy for DLBCL, with the exception of no more than 5 days of treatment with glucocorticoids for symptom control.
- International Prognostic Index score of 3-5.
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- Computed Tomography(CT)/Positron emission tomography (PET) positive measurable disease per the Lugano Classification 2014, having at least 1 node with longest diameter (LDi) greater than > 1.5cm or 1 extranodal lesion with LDi >1 cm.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- Adequate bone marrow function at Screening(Except for underlying diseases, such as secondary hypersplenism due to bone marrow invasion or splenic invasion identified by the investigator).
- Absolute neutrophil count (ANC)≥1.5×109/L;
- Platelet count (PLT) ≥100×109/L(no platelet transfusion within 14 days prior to C1D1), or PLT≥ 75×109/L if due to lymphoma with bone marrow involvement.
- Hemoglobin (HB)≥85g/L(no red blood cell transfusion within 14 days prior to C1D1).
- Adequate hepatic and renal function:
- Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) ≤2.0 x upper limit of normal (ULN), or AST and ALT≤5.0 x ULN(if due to lymphoma involvement),
- Serum total bilirubin ≤2×ULN, or Serum total bilirubin ≤5×ULN if due to Gilbert syndrome or lymphoma involvement.
- Estimated creatinine clearance ≥ 30 mL/min (calculated using the formula of Cockroft-Gault).
- Participants of childearing potential must agree to use highly effective methods of contraception during the duration of the study and following the last dose of study treatment, female and male participants should continue contraception for 14 and 11 months, respectively.
- Female participants of childbearing potential must have a negative serum pregnancy test at screening(Non-Childbearing potential: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy).
- Male participants must agree to avoid sperm donation during the duration of the study and 14 months following the last dose of study treatment.
- Patients must meet all of the following inclusion criteria to be eligible to enroll in this study:
- Willing and able to written informed consent (ICF) .
- Age ≥ 18 years and ≤ 75 years.
- Histologically confirmed Diffuse Large B-Cell Lymphoma of the germinal center B-cell(DLBCL) subtype by Hans.
- Patients no prior chemotherapy or radiotherapy for DLBCL, with the exception of no more than 5 days of treatment with glucocorticoids for symptom control.
- International Prognostic Index score of 3-5.
- Computed Tomography(CT)/Positron emission tomography (PET) positive measurable disease per the Lugano Classification 2014, having at least 1 node with longest diameter (LDi) greater than > 1.5cm or 1 extranodal lesion with LDi >1 cm.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- Adequate bone marrow function at Screening(Except for underlying diseases, such as secondary hypersplenism due to bone marrow invasion or splenic invasion identified by the investigator).
- Absolute neutrophil count (ANC)≥1.5×109/L;
- Platelet count (PLT) ≥100×109/L(no platelet transfusion within 14 days prior to C1D1), or PLT≥ 75×109/L if due to lymphoma with bone marrow involvement.
- Hemoglobin (HB)≥85g/L(no red blood cell transfusion within 14 days prior to C1D1).
- Adequate hepatic and renal function:
- Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) ≤2.0 x upper limit of normal (ULN), or AST and ALT≤5.0 x ULN(if due to lymphoma involvement),
- Serum total bilirubin ≤2×ULN, or Serum total bilirubin ≤5×ULN if due to Gilbert syndrome or lymphoma involvement.
- Estimated creatinine clearance ≥ 30 mL/min (calculated using the formula of Cockroft-Gault).
- Participants of childearing potential must agree to use highly effective methods of contraception during the duration of the study and following the last dose of study treatment, female and male participants should continue contraception for 14 and 11 months, respectively.
- Female participants of childbearing potential must have a negative serum pregnancy test at screening(Non-Childbearing potential: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy).
- Male participants must agree to avoid sperm donation during the duration of the study and 14 months following the last dose of study treatment.
Who cannot join
- Patients who meet any of the following criteria will not be enrolled:
- DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma; composite lymphoma (Hodgkin lymphoma + NHL); Gray zone lymphoma; DLBCL transformed from Chronic Lymphocytic Leukemia (Richter Syndrome); Primary mediastinal large B-cell lymphoma (PMBCL); T-cell rich large B-cell lymphoma.
- Known active central nervous system lymphoma or meningeal involvement at screening. Participants with a history of CNS disease treated into remission may be enrolled. The DLBCL of Testis involvement or more than two extranodal involvement.
- Previous treatment with selinexor or other XPO1 inhibitors.
- Contraindication to any drug contained in these regimen.
- Major surgery <14 days of C1D1, Except for disease diagnosis.
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- Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the participant's safety, or able to comply with the study procedures.
- Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 7 days prior to first dose of study treatment; however, prophylactic use of these agents is acceptable (including parenteral).
- Subjects with known active Hepatitis B (HB) infection, active Hepatitis C (HCV) infection or Human Immunodeficiency Virus (HIV) positivity. Participants with active hepatitis B Virus (HBV) are eligible if antiviral therapy for hepatitis B has been given for >8 weeks and viral load is <100 international units per milliliter (IU/mL); participants with untreated hepatitis C Virus (HCV) are eligible if viral load is negative per institutional standard; participants with human immunodeficiency virus (HIV) are eligible if cluster of differentiation 4 (CD4+) T-cell counts ≥350 cells per microliter (cells/μL), viral load is negative and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections in the last year.
- Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 7 days prior to first dose of study treatment; however, prophylactic use of these agents is acceptable (including parenteral).
- Breastfeeding women or pregnant women.
- In the opinion of the Investigator, participants who are below their ideal body weight and would be unduly impacted by changes in their weight.
- Life expectancy of less than 6 months.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Hui Zhou, Ph.D
Hui Zhou, Ph.D
- Recruiting
Department of Medical Oncology, Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
Zhiming Li, MD, +86-13719189172, lizhm@sysucc.org.cn
Yu Wang, MD, +86-20-87343765, wangyu@sysucc.org.cn
- Not yet recruiting
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, 315000
Ying Lu, Ph.D
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Lu Zhang, Ph.D
- Not yet recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Huijin Wu, Ph.D
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Keshu Zhou, Ph.D
About this study
Official title: Frontline Selinexor(ATG-010) Plus R-CHOP Therapy for High-risk GCB-subtype Diffuse Large B-Cell Lymphoma
This is a phase II, multicenter, single-arm and open-label study to explore Selinexor in combination with standard of care R-CHOP in New Diagnosed high-risk GCB-subtype DLBCL (IPI 3-5). Approximately 35 patients plan to be enrolled in about 6-8 study sites of the study. And the objective is to Evaluate the safety and efficacy of XR-CHOP in High-Risk (IPI 3-5) GCB-subtype DLBCL.The enrollment period for this study is expected to be approximately 18 months. The study will end when all patients have completed 6 cycles treatment/follow-up since the initiation of the study drug, or the last patient has expired, has been lost to follow-up, or has withdrawn consent, whichever occurs first.
Read the detailed description
This is a phase II, multicenter, single-arm and open-label study to explore Selinexor in combination with standard of care R-CHOP in New Diagnosed high-risk GCB-subtype DLBCL (IPI 3-5). Approximately 35 patients plan to be enrolled in about 6-8 study sites of the study.
Enrolled patients will be treated with 6 cycles of R-CHOP (Rituximab 375 mg/m2, cyclophosphamide 750 mg/m2 , doxorubicin 50 mg/m2 IV, vincristine 0.5 mg/kg on day 1, prednisone 100 mg po on days 1-5 in a 21 day cycle) and a fixed dose, 60 mg of selinexor, orally, weekly, each 3 week a cycle. Disease assessment will be made by positron emission tomography computed tomography (PET-CT) or PET- magnetic resonance imaging (MRI) scans (if CT is contraindicated) at screening (within 14 days of Cycle 1 Day 1). The PET-CT or PET-MRI scans (if CT is contraindicated) will be performed on Cycle 3 Day 1 (±1 week) and then every 8 weeks ± 1 week (i.e., Day 1 of odd numbered cycles) until disease progression is confirmed. The CT (or MRI) is allowed at alternating assessment time points (i.e., every 16 weeks, or every other scan) to replace PET if PET cannot be performed for every assessment.
Enrolled patients will be treated with 6 cycles of R-CHOP (Rituximab 375 mg/m2, Cyclophosphamide 750 mg/m2, Doxorubicin 50 mg/m2 IV, Vincristine 0.5 mg/kg on day 1, Prednisone 100 mg po on days 1-5 in a 21 day cycle) and a fixed dose, 60 mg of selinexor, orally, weekly, each 3 week a cycle. Treatment will continue for six cycles, or until intolerability, inadequate response, disease progression, consent withdrawal, or death, whichever occur first.
Two additional Rituximab doses (1 dose/21-day cycle) are permitted at cycles 7 and 8 if prespecified and considered standard of care per local practice. Investigators could prospectively give prespecified local radiotherapy consolidation after chemotherapy to treat a particular bulky disease site (at least 7 cm) or large mass. Additional prophylaxis or supportive care are recommended for better patient management.
The enrollment period for this study is expected to be approximately 18 months. The study will end when all patients have completed 6 cycles treatment/follow-up since the initiation of the study drug, or the last patient has expired, has been lost to follow-up, or has withdrawn consent, whichever occurs first.
- Conditions
- DLBCL Germinal Center B-Cell Type
- Being tested
- Selinexor, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine
- Keywords
- Selinexor, Xpovio, Newly Diagnosed, DLBCL, IPI 3-5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelinexorDrug
Also called ATG-010, Xpovio
Selinexor (ATG-010# is a first-in-class, oral selective exportin 1 (XPO1) inhibitor (1,2). Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus along with inhibition of translation of oncoprotein mRNAs. Selinexor 60mg on day 1,8,15 for 21 days cycles
RituximabDrug
Also called RiTUXimab Injection
Induction Chemotherapy: 375mg/sqm, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease, up to 6 cycles.
CyclophosphamideDrug
Also called Cyclophosphamide Injection
Induction Chemotherapy: 750mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease, up to 6 cycles.
DoxorubicinDrug
Also called Doxorubicin Hydrochloride
Induction Chemotherapy: 70mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease, up to 6 cycles.
VincristineDrug
Also called Vincristine Injection
Induction Chemotherapy: 1.4mg/m2 (Max: 2mg), Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease, up to 6 cycles.
PrednisoneDrug
Also called Prednisone Oral Product
Induction Chemotherapy: 100mg, oral administration on day 1 to 5 of each 3-week cycle until disease progression/stable disease, up to 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Selinexor-R-CHOP | Experimental | Selinexor po 60mg once weekly, Rituximab iv 375 mg/sqm on day 1, Cyclophosphamide iv 750 mg/sqm on day 1, Doxorubicin iv 50 mg/sqm on day 1, Vincristine iv 0.5 mg/kg on day 1, Prednisone po 100mg on days 1-5 in a 21 days per cycle. Receives: Drug: Selinexor; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate (CR)
Complete Remission (CR) rate at any time up of cycle 6 defined by Lugano 2014 defined response. Number of patients who achieved complete response after treatment by XR-CHOP
Measured: up to 18 months
Secondary outcomes (5)
Overall Response Rate (ORR)
Overall Response Rate (ORR) per the Lugano Classification 2014 [ Time Frame: Cycle 1 Day 1 (each cycle consists of maximum 21 days) until a complete response (CR) or partial response (PR)
Measured: up to 18 months
Progression Free Survival(PFS)
Duration from start of study treatment to Progressive disease(PD) or death (regardless of cause), whichever comes first.
Measured: up to 18 months
Disease free survival(DFS)
To assess only the population with the best response to CR, Duration from patients who achieve CR or better time to first occurrence of PD or death(regardless of cause),whichever comes first.
Measured: up to 18 months
Overall survival(OS)
Duration from start of study treatment to death (regardless of cause).
Measured: up to 18 months
Safety/toxicity profile
Adverse events as per CTCAE. V5.0. Number of Participants With Adverse Events (AEs) by Occurrence, Nature, and Severity [ Time
Measured: From start of study drug administration up to 30 days after last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start26 Jul 2022
- 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 DLBCL Germinal Center B-Cell TypeStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Zhiming
- Sponsor type
- University, hospital or other
- Collaborators
- Antengene Corporation
- Responsible party
- Sponsor-investigator, Li Zhiming, Sun Yat-sen University
- Investigators
- Zhiming Li, Ph.D, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422066
- Sponsor's protocol ID
- ATG-010-MA-CL-DLBCL-002
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2022
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD results are used for publication,and can be shared with other investigators and sponsors
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frontline Selinexor(ATG-010) Plus R-CHOP Therapy for High-risk GCB-subtype Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT05422066
- Acronym / sponsor ID
- ATG-010-MA-CL-DLBCL-002
- Conditions
- DLBCL Germinal Center B-Cell Type
- Keywords
- Selinexor, Xpovio, Newly Diagnosed, DLBCL, IPI 3-5
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Li ZhimingUniversity, hospital or other
- Collaborators
- Antengene Corporation
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Jun 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 is a phase II, multicenter, single-arm and open-label study to explore Selinexor in combination with standard of care R-CHOP in New Diagnosed high-risk GCB-subtype DLBCL (IPI 3-5). Approximately 35 patients plan to be enrolled in about 6-8 study sites of the study. And the objective is to Evaluate the safety and efficacy of XR-CHOP in High-Risk (IPI 3-5) GCB-subtype DLBCL.The enrollment period for this study is expected to be approximately 18 months. The study will end when all patients have completed 6 cycles treatment/follow-up since the initiation of the study drug, or the last patient has expired, has been lost to follow-up, or has withdrawn consent, whichever occurs first.
Detailed description
This is a phase II, multicenter, single-arm and open-label study to explore Selinexor in combination with standard of care R-CHOP in New Diagnosed high-risk GCB-subtype DLBCL (IPI 3-5). Approximately 35 patients plan to be enrolled in about 6-8 study sites of the study.
Enrolled patients will be treated with 6 cycles of R-CHOP (Rituximab 375 mg/m2, cyclophosphamide 750 mg/m2 , doxorubicin 50 mg/m2 IV, vincristine 0.5 mg/kg on day 1, prednisone 100 mg po on days 1-5 in a 21 day cycle) and a fixed dose, 60 mg of selinexor, orally, weekly, each 3 week a cycle. Disease assessment will be made by positron emission tomography computed tomography (PET-CT) or PET- magnetic resonance imaging (MRI) scans (if CT is contraindicated) at screening (within 14 days of Cycle 1 Day 1). The PET-CT or PET-MRI scans (if CT is contraindicated) will be performed on Cycle 3 Day 1 (±1 week) and then every 8 weeks ± 1 week (i.e., Day 1 of odd numbered cycles) until disease progression is confirmed. The CT (or MRI) is allowed at alternating assessment time points (i.e., every 16 weeks, or every other scan) to replace PET if PET cannot be performed for every assessment.
Enrolled patients will be treated with 6 cycles of R-CHOP (Rituximab 375 mg/m2, Cyclophosphamide 750 mg/m2, Doxorubicin 50 mg/m2 IV, Vincristine 0.5 mg/kg on day 1, Prednisone 100 mg po on days 1-5 in a 21 day cycle) and a fixed dose, 60 mg of selinexor, orally, weekly, each 3 week a cycle. Treatment will continue for six cycles, or until intolerability, inadequate response, disease progression, consent withdrawal, or death, whichever occur first.
Two additional Rituximab doses (1 dose/21-day cycle) are permitted at cycles 7 and 8 if prespecified and considered standard of care per local practice. Investigators could prospectively give prespecified local radiotherapy consolidation after chemotherapy to treat a particular bulky disease site (at least 7 cm) or large mass. Additional prophylaxis or supportive care are recommended for better patient management.
The enrollment period for this study is expected to be approximately 18 months. The study will end when all patients have completed 6 cycles treatment/follow-up since the initiation of the study drug, or the last patient has expired, has been lost to follow-up, or has withdrawn consent, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Selinexor-R-CHOP | Experimental | Drug: Selinexor, Drug: Rituximab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: PrednisoneSelinexor po 60mg once weekly, Rituximab iv 375 mg/sqm on day 1, Cyclophosphamide iv 750 mg/sqm on day 1, Doxorubicin iv 50 mg/sqm on day 1, Vincristine iv 0.5 mg/kg on day 1, Prednisone po 100mg on days 1-5 in a 21 days per cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (38 listed)
- Patients must meet all of the following inclusion criteria to be eligible to enroll in this study:
- Patients must meet all of the following inclusion criteria to be eligible to enroll in this study:
- Willing and able to written informed consent (ICF) .
- Age ≥ 18 years and ≤ 75 years.
- Histologically confirmed Diffuse Large B-Cell Lymphoma of the germinal center B-cell(DLBCL) subtype by Hans.
Key exclusion criteria (13 listed)
- DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma; composite lymphoma (Hodgkin lymphoma + NHL); Gray zone lymphoma; DLBCL transformed from Chronic Lymphocytic Leukemia (Richter Syndrome); Primary mediastinal large B-cell lymphoma (PMBCL); T-cell rich large B-cell lymphoma.
- Known active central nervous system lymphoma or meningeal involvement at screening. Participants with a history of CNS disease treated into remission may be enrolled. The DLBCL of Testis involvement or more than two extranodal involvement.
- Previous treatment with selinexor or other XPO1 inhibitors.
- Contraindication to any drug contained in these regimen.
- Major surgery <14 days of C1D1, Except for disease diagnosis.
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 |
|---|---|---|
| SelinexorAlso: ATG-010, XpovioSelinexor (ATG-010# is a first-in-class, oral selective exportin 1 (XPO1) inhibitor (1,2). Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus along with inhibition of translation of oncoprotein mRNAs. Selinexor 60mg on day 1,8,15 for 21 days cycles | Drug | Selinexor-R-CHOP |
| RituximabAlso: RiTUXimab InjectionInduction Chemotherapy: 375mg/sqm, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease, up to 6 cycles. | Drug | Selinexor-R-CHOP |
| CyclophosphamideAlso: Cyclophosphamide InjectionInduction Chemotherapy: 750mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease, up to 6 cycles. | Drug | Selinexor-R-CHOP |
| DoxorubicinAlso: Doxorubicin HydrochlorideInduction Chemotherapy: 70mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease, up to 6 cycles. | Drug | Selinexor-R-CHOP |
| VincristineAlso: Vincristine InjectionInduction Chemotherapy: 1.4mg/m2 (Max: 2mg), Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease, up to 6 cycles. | Drug | Selinexor-R-CHOP |
| PrednisoneAlso: Prednisone Oral ProductInduction Chemotherapy: 100mg, oral administration on day 1 to 5 of each 3-week cycle until disease progression/stable disease, up to 6 cycles. | Drug | Selinexor-R-CHOP |
Primary outcome
Complete Response Rate (CR)
Time frame: up to 18 months
Complete Remission (CR) rate at any time up of cycle 6 defined by Lugano 2014 defined response. Number of patients who achieved complete response after treatment by XR-CHOP
5 secondary outcomes
Overall Response Rate (ORR)
Time frame: up to 18 months
Progression Free Survival(PFS)
Time frame: up to 18 months
Disease free survival(DFS)
Time frame: up to 18 months
Overall survival(OS)
Time frame: up to 18 months
Safety/toxicity profile
Time frame: From start of study drug administration up to 30 days after last dose of study treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: Yes. All IPD results are used for publication,and can be shared with other investigators and sponsors
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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.
Zhiming Li, Ph.D principal investigator
Sun Yat-sen University
6 sites 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, Rituximab and Cyclophosphamide in people with DLBCL Germinal Center B-Cell Type, run by Li Zhiming at 6 sites 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 38 inclusion and 13 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 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 Zhiming Li, Ph.D (+86-020-87343765, lizhm@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate (CR) (time frame: up to 18 months). 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 17 Jun 2024.