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Selinexor Plus R-CHOP in High-risk GCB-subtype Diffuse Large B-Cell Lymphoma

Primary Purpose

DLBCL Germinal Center B-Cell Type

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Selinexor

Rituximab

Cyclophosphamide

Doxorubicin

Vincristine

Prednisone

About this trial

This is an interventional treatment trial for DLBCL Germinal Center B-Cell Type focused on measuring Selinexor, Xpovio, Newly Diagnosed, DLBCL, IPI 3-5

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible to enroll in this study:
1. Willing and able to written informed consent (ICF) .
2. Age ≥ 18 years and ≤ 75 years.
3. Histologically confirmed Diffuse Large B-Cell Lymphoma of the germinal center B-cell(DLBCL) subtype by Hans.
4. Patients no prior chemotherapy or radiotherapy for DLBCL, with the exception of no more than 5 days of treatment with glucocorticoids for symptom control.
5. International Prognostic Index score of 3-5.
6. 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.
7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
8. 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).
  1. Absolute neutrophil count (ANC)≥1.5×109/L;
  2. 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.
  3. Hemoglobin (HB)≥85g/L(no red blood cell transfusion within 14 days prior to C1D1).
9. Adequate hepatic and renal function:
  1. 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),
  2. Serum total bilirubin ≤2×ULN, or Serum total bilirubin ≤5×ULN if due to Gilbert syndrome or lymphoma involvement.
  3. Estimated creatinine clearance ≥ 30 mL/min (calculated using the formula of Cockroft-Gault).
10. 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.
  1. 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).
  2. Male participants must agree to avoid sperm donation during the duration of the study and 14 months following the last dose of study treatment.

Exclusion Criteria:

Inclusion/Exclusion Criteria:

Inclusion Criteria:

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).
1. Absolute neutrophil count (ANC)≥1.5×109/L;
2. 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.
3. Hemoglobin (HB)≥85g/L(no red blood cell transfusion within 14 days prior to C1D1).
Adequate hepatic and renal function:
1. 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),
2. Serum total bilirubin ≤2×ULN, or Serum total bilirubin ≤5×ULN if due to Gilbert syndrome or lymphoma involvement.
3. 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.
1. 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).
2. Male participants must agree to avoid sperm donation during the duration of the study and 14 months following the last dose of study treatment.

Exclusion Criteria:

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.
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.

Sites / Locations

Department of Medical Oncology, Sun Yat-Sen University Cancer CenterRecruiting
Henan Cancer Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hubei Cancer Hospital
Hunan Cancer Hospital
The Affiliated People's Hospital of Ningbo University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Selinexor-R-CHOP

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Progression Free Survival(PFS)

Duration from start of study treatment to Progressive disease(PD) or death (regardless of cause), whichever comes first.

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.

Overall survival(OS)

Duration from start of study treatment to death (regardless of cause).

Safety/toxicity profile

Adverse events as per CTCAE. V5.0. Number of Participants With Adverse Events (AEs) by Occurrence, Nature, and Severity [ Time

Full Information

NCT ID

NCT05422066

First Posted

June 13, 2022

Last Updated

July 27, 2023

Sponsor

Li Zhiming

Collaborators

Antengene Corporation

1. Study Identification

Unique Protocol Identification Number

NCT05422066

Brief Title

Selinexor Plus R-CHOP in High-risk GCB-subtype Diffuse Large B-Cell Lymphoma

Official Title

Frontline Selinexor(ATG-010) Plus R-CHOP Therapy for High-risk GCB-subtype Diffuse Large B-Cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 26, 2022 (Actual)

Primary Completion Date

July 30, 2025 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Li Zhiming

Collaborators

Antengene Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

DLBCL Germinal Center B-Cell Type

Keywords

Selinexor, Xpovio, Newly Diagnosed, DLBCL, IPI 3-5

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Selinexor-R-CHOP

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Selinexor

Other Intervention Name(s)

ATG-010, Xpovio

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Rituximab

Other Intervention Name(s)

RiTUXimab Injection

Intervention Description

Induction Chemotherapy: 375mg/sqm, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease, up to 6 cycles.

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Other Intervention Name(s)

Cyclophosphamide Injection

Intervention Description

Induction Chemotherapy: 750mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease, up to 6 cycles.

Intervention Type

Drug

Intervention Name(s)

Doxorubicin

Other Intervention Name(s)

Doxorubicin Hydrochloride

Intervention Description

Induction Chemotherapy: 70mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease, up to 6 cycles.

Intervention Type

Drug

Intervention Name(s)

Vincristine

Other Intervention Name(s)

Vincristine Injection

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Prednisone

Other Intervention Name(s)

Prednisone Oral Product

Intervention Description

Induction Chemotherapy: 100mg, oral administration on day 1 to 5 of each 3-week cycle until disease progression/stable disease, up to 6 cycles.

Primary Outcome Measure Information:

Title

Complete Response Rate (CR)

Description

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

Time Frame

up to 18 months

Secondary Outcome Measure Information:

Title

Overall Response Rate (ORR)

Description

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)

Time Frame

up to 18 months

Title

Progression Free Survival(PFS)

Description

Duration from start of study treatment to Progressive disease(PD) or death (regardless of cause), whichever comes first.

Time Frame

up to 18 months

Title

Disease free survival(DFS)

Description

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.

Time Frame

up to 18 months

Title

Overall survival(OS)

Description

Duration from start of study treatment to death (regardless of cause).

Time Frame

up to 18 months

Title

Safety/toxicity profile

Description

Adverse events as per CTCAE. V5.0. Number of Participants With Adverse Events (AEs) by Occurrence, Nature, and Severity [ Time

Time Frame

From start of study drug administration up to 30 days after last dose of study treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: Inclusion/Exclusion Criteria: Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhiming Li, Ph.D

Phone

+86-020-87343765

lizhm@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhiming Li, Ph.D

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Medical Oncology, Sun Yat-Sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhiming Li, MD

Phone

+86-13719189172

lizhm@sysucc.org.cn

First Name & Middle Initial & Last Name & Degree

Yu Wang, MD

Phone

+86-20-87343765

wangyu@sysucc.org.cn

Facility Name

Henan Cancer Hospital

City

Zhengzhou

State/Province

Henan

ZIP/Postal Code

450008

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Keshu Zhou, Ph.D

Facility Name

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430022

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lu Zhang, Ph.D

Facility Name

Hubei Cancer Hospital

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430079

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Huijin Wu, Ph.D

Facility Name

Hunan Cancer Hospital

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410013

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hui Zhou, Ph.D

First Name & Middle Initial & Last Name & Degree

Hui Zhou, Ph.D

Facility Name

The Affiliated People's Hospital of Ningbo University

City

Ningbo

State/Province

Zhejiang

ZIP/Postal Code

315000

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ying Lu, Ph.D

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All IPD results are used for publication,and can be shared with other investigators and sponsors

IPD Sharing Time Frame

Study Protocol can be shared Starting 12 months after publication

IPD Sharing Access Criteria

Study Protocol must not be shared with non-participants until after publication and must be authorized by the principal investigator and sponsors

Learn more about this trial

Selinexor Plus R-CHOP in High-risk GCB-subtype Diffuse Large B-Cell Lymphoma

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