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A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab As Monotherapy or Combined With Standard of Care Therapies in Adult Participants in China With B-Cell Non-Hodgkin Lymphoma

Primary Purpose

B-Cell Non-Hodgkin Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Epcoritamab
Cyclophosphamide
Rituximab
Doxorubicin
Vincristine
Prednisone
Lenalidomide
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-Cell Non-Hodgkin Lymphoma focused on measuring B-Cell Non-Hodgkin Lymphoma, Epcoritamab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, R-CHOP, Rituximab, Lenalidomide, R2, ABBV-GMAB-3013, Cancer, EPCORE

Eligibility Criteria

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

Inclusion Criteria:

All Cohorts:

  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2.
  • Has one or more measurable disease sites:

    • Fluorodeoxyglucose-positron emission tomography (FDGPET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites.
    • >= 1 measurable nodal lesion (long axis >= 1.5 cm and short axis > 1.0 cm) or >= 1 measurable extra-nodal lesion (long axis >= 1 cm) on CT scan or MRI. Note: A previously irradiated lesion must have demonstrated progression or residual disease in the lesion after radiotherapy to be considered measurable.

Cohort 1 Part 1 (Monotherapy Safety Run-in) Specific Criteria:

  • Must have histologically confirmed CD20+ Diffuse large B-cell lymphoma (DLBCL), or High-grade B-cell lymphoma (HGCBL) with MYC and BCL2 and/or BCL6 translocations and DLBCL feature, and follicular Lymphoma (FL) at most recent (previous or current) representative tumor biopsy based on the pathology report, according to the World Health Organization (WHO) 2016 classification.
  • Must have at least one prior treatment with an anti-CD20 monoclonal antibody (e.g., rituximab) potentially in combination with chemotherapy and/or relapsed after autologous stem cell rescue.
  • Must have relapsed or refractory disease. Relapsed disease is defined as disease that has recurred >= 6 months after completion of therapy. Refractory disease is defined as disease that either progressed during therapy or progressed within 6 months (<6 months) of completion of therapy.

Cohort 1 Part 2 (Monotherapy Expansion) Specific Criteria:

  • Must have histologically confirmed DLBCL and documented in pathology report, inclusive of the following pathology report, according to the World Health Organization (WHO) 2016 classification.

    • DLBCL, not otherwise specified (NOS) including de novo or histologically transformed from an earlier diagnosis of indolent lymphoma such as FL and nodal marginal zone lymphoma with a subsequent development of DLBCL relapse or.
    • "Double-hit" or "triple-hit" with DLBCL morphology (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations). Note: Double- /triple-hit lymphomas without DLBCL morphology and those classified in WHO 2016 as HGBCL, NOS are not eligible.
    • FL Grade 3B.
  • Following safety run-in and up to the 12th participant (including the number of safety run-in participants) in Cohort 1, participant must have received at least 1 prior line of systemic therapies which must include an anti-CD20 monoclonal antibody containing combination therapy (e.g., rituximab). After 12 participants have been enrolled at dose A of epcoritamab, participants must have received at least 2 prior lines of systemic therapies.
  • Must have either failed prior autologous HSCT, or be ineligible for autologous HSCT due to age, comorbidities, performance status, comorbidities, or insufficient response to prior treatment.
  • Must have relapsed or refractory disease.

Cohort 2 Specific Criteria:

  • Must have newly diagnosed DLBCL.
  • Double-/triple-hit DLBCL (categorized in WHO 2016 as high-grade B-cell lymphoma [HGBCL] with MYC and BCL2 and/or BCL6 rearrangements)*

    * Note: other histologies with MYC and BCL2 and/or BCL6 translocations are excluded.

  • Eligible for standard R-CHOP for 6 cycles.

Cohort 3 Specific Criteria:

  • Must have histologically confirmed Grade 1 - 3a Follicular Lymphoma stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma at most recent (previous or current) representative tumor biopsy and CD20+ on a representative tumor biopsy based on the pathology report, according to the WHO 2016 classification.
  • Must have R/R disease to at least one prior systemic anti-lymphoma treatment which must include an anti CD20 monoclonal antibody (e.g., rituximab). Participant who received only prior anti-CD20 monoclonal antibody monotherapy is not eligible. Note: Relapsed disease is defined as disease that previously responded to therapy but progressed >= 6 months after completion of therapy. Refractory disease is defined as disease that either progressed during therapy, failed to achieve an objective response or progressed within 6 months (< 6 months) of completion of therapy.
  • Must be eligible for R2 per investigator determination.
  • Willing to take aspirin prophylaxis (participants with low or intermediate risk for thromboembolism) or prophylactic anticoagulant (if high risk for a thromboembolic event) (lenalidomide treated participants only).

Exclusion Criteria:

All Cohorts:

  • History of primary mediastinal lymphoma.
  • Autologous Stem Cell Transplantation within 100 days prior to enrollment.
  • Have received prior allogeneic hematopoietic stem cell transplantation at any time.
  • Have been treated with a bispecific antibody targeting CD3 and CD20.

Cohort 2 Specific Criteria:

- History of prior systemic anti-lymphoma therapy (including definitive radiotherapy) for Diffuse large B-cell lymphoma (DLBCL) other than corticosteroids.

Sites / Locations

  • Peking University Third Hospital /ID# 228138Recruiting
  • Fujian Medical University Union Hospital /ID# 231890Recruiting
  • Sun Yat-Sen University Cancer Center /ID# 228033Recruiting
  • Guangdong Provincial People's Hospital /ID# 228028Recruiting
  • Nanfang Hospital of Southern Medical University /ID# 227916Recruiting
  • Henan Cancer Hospital /ID# 228772Recruiting
  • Hunan Cancer Hospital /ID# 231859Recruiting
  • The First Affiliated Hospital of Soochow University /ID# 228024Recruiting
  • The Affiliated Hospital of Xuzhou Medical University /ID# 228774Recruiting
  • The First Affiliated Hospital of Nanchang University /ID# 228771Recruiting
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 227724Recruiting
  • West China Hospital, Sichuan University /ID# 231434Recruiting
  • Tianjin Medical University Cancer Institute and Hospital /ID# 228135Recruiting
  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 228154Recruiting
  • Zhejiang Cancer hospital /ID# 228776Recruiting
  • The Fifth Medical Center of PLA General Hospital /ID# 230520Recruiting
  • Jiangxi Cancer Hospital /ID# 231944Recruiting
  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 231221Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1 Part 1: Epcoritamab Monotherapy

Cohort 1 Part 2: Epcoritamab Expansion

Cohort 2: Epcoritamab + RCHOP

Cohort 3: Epcoritamab + R2

Arm Description

Participants will receive subcutaneous (SC) epcoritamab in 28 day cycles.

Participants will receive SC epcoritamab in 28 day cycles.

Participants will receive SC epcoritamab in combination with [intravenously (IV) infused rituximab, IV injected cyclophosphamide, IV infused doxorubicin, IV infused vincristine, and oral prednisone (R-CHOP)] in 21 day cycles followed by 28 day cycles.

Participants will receive SC epcoritamab in combination with [intravenously (IV) infused rituximab, and oral lenalidomide (R2)] in 28 day cycles.

Outcomes

Primary Outcome Measures

Cohort 1 Part 2 [(3L+) R/R DLBCL]: Best Overall Response (BOR)
Best overall response (BOR) is defined as the percentage of participants in Cohort 1 Part 2 third line plus (3L) R/R DLBCL who achieved best overall response of complete response (CR) or partial response (PR) by Lugano 2014 criteria as assessed by independent review committee (IRC).
Cohort 1 Part 1, Cohort 2, and Cohort 3: Number of Incidence of Dose-Limiting Toxicities (DLT)
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.

Secondary Outcome Measures

Cohort 1 Part 2 [(3L+) R/R DLBCL]: Percentage of Participants with Complete Remission (CR)
CR is defined as the absence of lymphoma determined by Lugano 2014 criteria as assessed by IRC.
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Number of Participants with Progression-free survival (PFS)
PFS is defined as the time in months from the first dose of study drug to the earliest occurrence of radiographic progression determined by Lugano 2014 criteria as assessed by IRC, or death from any cause.
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Overall survival (OS)
OS is defined for Cohort 1 epcoritamab monotherapy participants, as the time in months from first dose of epcoritamab to death from any cause.
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Duration of response (DOR)
DOR is defined for participants who achieved best overall response of CR or PR ('responders'), as the time in months from initial CR/PR to the earliest occurrence of radiographic progression determined by Lugano 2014 criteria as assessed by IRC, or death from any cause.
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Time-to-response (TTR)
TTR is defined as the number of months from the date of first dose to the date of best overall response of CR or PR ('responders') determined by Lugano 2014 criteria as assessed by IRC.

Full Information

First Posted
January 18, 2022
Last Updated
August 7, 2023
Sponsor
AbbVie
Collaborators
Genmab
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1. Study Identification

Unique Protocol Identification Number
NCT05201248
Brief Title
A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab As Monotherapy or Combined With Standard of Care Therapies in Adult Participants in China With B-Cell Non-Hodgkin Lymphoma
Official Title
Phase 1b/2, Open-Label Trial to Evaluate Safety and Preliminary Efficacy of Epcoritamab As Monotherapy or Combined With Standard-of-Care Therapies in Chinese Subjects With B-Cell Non-Hodgkin Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
January 25, 2024 (Anticipated)
Study Completion Date
January 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
Collaborators
Genmab

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and toxicity of epcoritamab as a monotherapy and when combined with standard of care therapy [Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or Rituximab and lenalidomide (R2)] in adult participants in China with B-Cell Non-Hodgkin Lymphoma. Adverse events and change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of B-Cell Non-Hodgkin Lymphoma. Study doctors put the participants in groups called treatment arms. A monotherapy of epcoritamab and two different combination of epcoritamab with standard of care therapy (R-CHOP or R2) will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. Approximately 66 adult participants with B-Cell Non-Hodgkin Lymphoma will be enrolled in the study in approximately 21 sites in China. In the monotherapy arm (Cohort 1), participants will receive subcutaneous epcoritamab in 28-day cycles. In the combination arms (Cohorts 2 and 3), participants in Cohort 2 will receive subcutaneous epcoritamab with standard of care therapy (R-CHOP) in 21-day cycles followed by 28-day cycles, participants in Cohort 3 will receive subcutaneous epcoritamab with standard of care therapy (R2) in 28-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-Cell Non-Hodgkin Lymphoma
Keywords
B-Cell Non-Hodgkin Lymphoma, Epcoritamab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, R-CHOP, Rituximab, Lenalidomide, R2, ABBV-GMAB-3013, Cancer, EPCORE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 Part 1: Epcoritamab Monotherapy
Arm Type
Experimental
Arm Description
Participants will receive subcutaneous (SC) epcoritamab in 28 day cycles.
Arm Title
Cohort 1 Part 2: Epcoritamab Expansion
Arm Type
Experimental
Arm Description
Participants will receive SC epcoritamab in 28 day cycles.
Arm Title
Cohort 2: Epcoritamab + RCHOP
Arm Type
Experimental
Arm Description
Participants will receive SC epcoritamab in combination with [intravenously (IV) infused rituximab, IV injected cyclophosphamide, IV infused doxorubicin, IV infused vincristine, and oral prednisone (R-CHOP)] in 21 day cycles followed by 28 day cycles.
Arm Title
Cohort 3: Epcoritamab + R2
Arm Type
Experimental
Arm Description
Participants will receive SC epcoritamab in combination with [intravenously (IV) infused rituximab, and oral lenalidomide (R2)] in 28 day cycles.
Intervention Type
Drug
Intervention Name(s)
Epcoritamab
Other Intervention Name(s)
ABBV-GMAB-3013
Intervention Description
Subcutaneous Injection (SC)
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
IV Injection
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Intravenous (IV) Infusion
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
IV Infusion
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
IV Infusion
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Oral; Tablet
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Oral; Capsule
Primary Outcome Measure Information:
Title
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Best Overall Response (BOR)
Description
Best overall response (BOR) is defined as the percentage of participants in Cohort 1 Part 2 third line plus (3L) R/R DLBCL who achieved best overall response of complete response (CR) or partial response (PR) by Lugano 2014 criteria as assessed by independent review committee (IRC).
Time Frame
Up to Approximately 5 Years
Title
Cohort 1 Part 1, Cohort 2, and Cohort 3: Number of Incidence of Dose-Limiting Toxicities (DLT)
Description
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
Time Frame
Up to Approximately 5 Years
Secondary Outcome Measure Information:
Title
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Percentage of Participants with Complete Remission (CR)
Description
CR is defined as the absence of lymphoma determined by Lugano 2014 criteria as assessed by IRC.
Time Frame
Up to Approximately 5 Years
Title
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Number of Participants with Progression-free survival (PFS)
Description
PFS is defined as the time in months from the first dose of study drug to the earliest occurrence of radiographic progression determined by Lugano 2014 criteria as assessed by IRC, or death from any cause.
Time Frame
Up to Approximately 5 Years
Title
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Overall survival (OS)
Description
OS is defined for Cohort 1 epcoritamab monotherapy participants, as the time in months from first dose of epcoritamab to death from any cause.
Time Frame
Up to Approximately 5 Years
Title
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Duration of response (DOR)
Description
DOR is defined for participants who achieved best overall response of CR or PR ('responders'), as the time in months from initial CR/PR to the earliest occurrence of radiographic progression determined by Lugano 2014 criteria as assessed by IRC, or death from any cause.
Time Frame
Up to Approximately 5 Years
Title
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Time-to-response (TTR)
Description
TTR is defined as the number of months from the date of first dose to the date of best overall response of CR or PR ('responders') determined by Lugano 2014 criteria as assessed by IRC.
Time Frame
Up to Approximately 5 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All Cohorts: Life expectancy of >= 3 months on standard of care (SOC). Must have an Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2. Has one or more measurable disease sites: Fluorodeoxyglucose-positron emission tomography (FDGPET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites. >= 1 measurable nodal lesion (long axis > 1.5 cm and short axis > 1.0 cm) or >= 1.0 measurable extra-nodal lesion (long axis >= 1 cm) on CT scan or MRI. Note: A previously irradiated lesion must have demonstrated progression or residual disease in the lesion after radiotherapy to be considered measurable. Cohort 1 Part 1 (Monotherapy Safety Run-in) Specific Criteria: Must have histologically confirmed CD20+ Diffuse large B-cell lymphoma (DLBCL), or High-grade B-cell lymphoma (HGCBL) with MYC and BCL2 and/or BCL6 translocations and DLBCL feature, and follicular Lymphoma (FL) at most recent (previous or current) representative tumor biopsy based on the pathology report, according to the World Health Organization (WHO) 2016 (or later) classification. Must have at least one prior treatment with an anti-CD20 monoclonal antibody (e.g., rituximab) potentially in combination with chemotherapy and/or relapsed after autologous stem cell rescue. Must have relapsed or refractory disease. Note: Relapsed disease is defined as disease that has recurred >= 6 months after completion of therapy. Refractory disease is defined as disease that either progressed or failed to achieve an objective response during therapy or progressed within 6 months (<6 months) of completion of therapy. Cohort 1 Part 2 (Monotherapy Expansion) Specific Criteria: Must have histologically confirmed CD20+ DLBCL at most recent (previous or current) representative tumor biopsy based on the pathology report, inclusive of the following according to the World Health Organization (WHO) 2016 (or later) classification. DLBCL, not otherwise specified (NOS) including de novo or histologically transformed from an earlier diagnosis of indolent lymphoma such as FL and nodal marginal zone lymphoma with a subsequent development of DLBCL relapse or. "Double-hit" or "triple-hit" with DLBCL morphology (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations). Note: Double- /triple-hit lymphomas without DLBCL morphology and those classified in WHO 2016 as HGBCL, NOS are not eligible. FL Grade 3B. Following safety run-in and up to the 12th participant (including the number of safety run-in participants) in Cohort 1, participants must have received at least 1 prior line of systemic therapies which must include an anti-CD20 monoclonal antibody containing combination therapy (e.g., rituximab). After safety run-in confirms tolerability of the full dose A of epcoritamab, participants must have received at least 2 prior lines of systemic therapies. Must have either failed prior autologous HSCT, or be ineligible for autologous HSCT due to age, comorbidities, performance status, comorbidities, or insufficient response to prior treatment. Must have relapsed or refractory disease. Note: Relapsed disease is defined as disease that has recurred >= 6 months after completion of therapy. Refractory disease is defined as disease that either progressed or failed to achieve an objective response during therapy or progressed within 6 months (< 6 months) of completion of therapy. Cohort 2 Specific Criteria: Must have newly diagnosed CD20+ DLBCL. Must have one of the following histologically confirmed CD20+ DLBCL (de novo or histologically transformed from FL at most recent (previous or current) representative tumor biopsy based on the pathology report including one of the following diagnoses according to the WHO 2016 (or later) classification: DLBCL, not otherwise specified (NOS); "Double-hit" or "triple-hit" with DLBCL morphology (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations) Note: Double-/triple-hit lymphomas without DLBCL morphology and those classified in WHO 2016 as HGBCL, NOS are not eligible or; FL Grade 3B Eligible for standard R-CHOP for 6 cycles. Cohort 3 Specific Criteria: Must have histologically confirmed CD20+ Grade 1 - 3a Follicular Lymphoma stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma at most recent (previous or current) representative tumor biopsy and based on the pathology report, according to the WHO 2016 (or later) classification. Must have R/R disease to at least one prior systemic anti-lymphoma treatment which must include an anti CD20 monoclonal antibody (e.g., rituximab). Participant who received only prior anti-CD20 monoclonal antibody monotherapy is not eligible. Note: Relapsed disease is defined as disease that previously responded to therapy but progressed >= 6 months after completion of therapy. Refractory disease is defined as disease that either progressed during therapy, failed to achieve an objective response or progressed within 6 months (< 6 months) of completion of therapy. Must be eligible for R2 per investigator determination. Willing to take aspirin prophylaxis (participants with low or intermediate risk for thromboembolism) or prophylactic anticoagulant (if high risk for a thromboembolic event) (lenalidomide treated participants only). Exclusion Criteria: All Cohorts: History of primary mediastinal lymphoma. Autologous Stem Cell Transplantation within 100 days prior to enrollment. Have received prior allogeneic hematopoietic stem cell transplantation at any time. Have been treated with a bispecific antibody targeting CD3 and CD20. Cohort 2 Specific Criteria: - History of prior systemic anti-lymphoma therapy (including definitive radiotherapy) for Diffuse large B-cell lymphoma (DLBCL) other than corticosteroids.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Third Hospital /ID# 228138
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Name
Fujian Medical University Union Hospital /ID# 231890
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Name
Sun Yat-Sen University Cancer Center /ID# 228033
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Name
Guangdong Provincial People's Hospital /ID# 228028
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Name
Nanfang Hospital of Southern Medical University /ID# 227916
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Cancer Hospital /ID# 228772
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Name
Hunan Cancer Hospital /ID# 231859
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410006
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Soochow University /ID# 228024
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Name
The Affiliated Hospital of Xuzhou Medical University /ID# 228774
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Nanchang University /ID# 228771
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 227724
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200065
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital, Sichuan University /ID# 231434
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University Cancer Institute and Hospital /ID# 228135
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300222
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 228154
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang Cancer hospital /ID# 228776
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Name
The Fifth Medical Center of PLA General Hospital /ID# 230520
City
Beijing
ZIP/Postal Code
100071
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangxi Cancer Hospital /ID# 231944
City
Nanchang
ZIP/Postal Code
330029
Country
China
Individual Site Status
Recruiting
Facility Name
Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 231221
City
Wuhan
ZIP/Postal Code
420022
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/

Learn more about this trial

A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab As Monotherapy or Combined With Standard of Care Therapies in Adult Participants in China With B-Cell Non-Hodgkin Lymphoma

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