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A Study on Pharmacokinetics (PK), Efficacy and Safety of Subcutaneous (SC) Versus Intravenous (IV) Rituximab, in Combination With CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) in Previously Untreated Participants With CD20 Positive Diffuse Large B-Cell Lymphoma (DLBCL)

Primary Purpose

Lymphoma, Large B-Cell, Diffuse

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Rituximab IV

Rituximab SC

Rituximab IV

Cyclophosphamide

Doxorubicin

Vincristine

Prednisone

Paracetamol

Diphenhydramine hydrochloride or alternative antihistamine

About this trial

This is an interventional treatment trial for Lymphoma, Large B-Cell, Diffuse focused on measuring Mabthera, Rituximab, SC, Subcutaneous, DLBCL

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Previously untreated CD20 positive diffuse large B-cell lymphoma (DLBCL)
Participants with an International Prognostic Index (IPI) score of 1 to 5 or IPI score of 0 with bulky disease, defined as one lesion >/=7.5 cm
At least one bi-dimensionally measurable lesion defined as >/=1.5 cm in its largest dimension on CT scan
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Left ventricular ejection fraction (LVEF) >/=50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram
A negative serum pregnancy test or a negative urine pregnancy test within 7 days prior to study treatment
For men who are not surgically sterile, agreement to use a barrier method of contraception during the treatment period and until >/=12 months after the last dose of rituximab SC or rituximab IV or according to institutional guidelines for CHOP chemotherapy, whichever is longer, and agreement to request that their partners use an additional method of contraception
For women of reproductive potential who are not surgically sterile, agreement to use adequate methods of contraception during the treatment period and until >/=12 months after the last dose of rituximab SC or rituximab IV or according to institutional guidelines for CHOP chemotherapy, whichever is longer
Adequate hematologic function confirmed within 14 days prior to randomization

Exclusion Criteria:

Transformed non-Hodgkin's lymphoma (NHL) or types of NHL other than DLBCL and its subtypes according to World Health Organization classification
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation or surgery for diagnosis
Prior treatment with cytotoxic drugs or rituximab for another condition (e.g.,rheumatoid arthritis) or prior use of an anti-CD20 antibody
Current or recent treatment with another investigational drug or participation in another investigational therapeutic study
Ongoing corticosteroid use (>30 mg/day of prednisone or equivalent)
Primary CNS lymphoma, blastic variant of mantle cell lymphoma, or histologic evidence of transformation to a Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, and primary cutaneous DLBCL
History of other malignancy that could affect compliance with the protocol or interpretation of results
Evidence of significant, uncontrolled concomitant diseases including but not limited to significant cardiovascular disease or pulmonary disease
Any of the following abnormal laboratory values: creatinine >1.5 upper limit of normal (ULN), aspartate aminotransferase (AST) / alanine aminotransferase (ALT) >2.5ULN, total bilirubin >1.5ULN, prothrombin time - international normalized ratio (PT-INR) / partial thromboplastin time (PTT) / activated partial thromboplastin time (aPTT)>1.5ULN
Positive test results for chronic hepatitis B (HBV) and or hepatitis C (HCV) infection; Participants with occult or prior HBV infection (defined as negative HBsAg and positive total hepatitis B core antibody [HBcAb]) may be included if HBV DNA is undetectable; Participants positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA
Known history of human immunodeficiency virus (HIV)

Sites / Locations

Peking University Third Hospital
The First Hospital of Jilin University
Fujian Provincial Cancer Hospital
Harbin Medical University Cancer Hospital
The 1st Affiliated Hospital of Nanchang Unversity
Tianjin Medical University Cancer Institute & Hospital
Union Hospital Tongji Medical College Huazhong University of Science and Technology
The First Affiliated Hospital of Xian Jiao Tong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Rituximab IV+CHOP

Rituximab SC+CHOP

Arm Description

Participants will receive 8 cycles of IV rituximab in combination with 6 or 8 cycles of CHOP chemotherapy administered every 3 weeks.

Participants will receive 1 cycle of IV plus 7 cycles of SC rituximab in combination with 6 or 8 cycles of CHOP chemotherapy administered every 3 weeks.

Outcomes

Primary Outcome Measures

Subcutaneous Serum Rituximab Trough Concentration (Ctrough SC) and Intravenous Serum Rituximab Trough Concentration (Ctrough IV)

For this pharmacokinetics (PK) primary outcome measure the serum rituximab Ctrough for SC and IV administrations were measured at Cycle 7, 21 days after study treatment administration for Cycle 7 (pre-dose of Cycle 8). Geometric mean ratio and 90% confidence interval were estimated based on an ANCOVA model adjusted for tumor load at baseline and are reported in the statistical analysis.

Secondary Outcome Measures

Observed SC and IV Rituximab Area Under the Curve (AUCsc and AUCiv)

The area under the curve (AUC) for serum rituximab concentration versus time after dosage was measured for SC and IV administrations during Cycle 7. Geometric mean ratio and 90% confidence interval were estimated based on an ANCOVA model adjusted for tumor load at baseline and are reported in the statistical analysis.

Maximum Observed Serum Concentration (Cmax) of Rituximab

Time to Cmax (Tmax) of Rituximab

Trough Serum Concentration (Ctrough) of Rituximab

Ctrough was measured at Cycle 2 and Cycle 7, 21 days after study treatment administration for each cycle (pre-dose of Cycle 3 and Cycle 8, respectively).

Area Under the Curve (AUC) of Rituximab

AUC is the area under the serum concentration curve over the dosing interval of 21 days during Cycle 2 and Cycle 7.

Complete Response Rate (CRR) as Determined by the Independent Review Committee (IRC) Using Lugano Response Criteria (LRC) for Malignant Lymphoma

Per LRC, CR based on positron emission tomography- computed tomography (PET-CT) was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass, on 5-point scale (5PS), where, 1= no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake > mediastinum but ≤ liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Per LRC, CR based on CT was defined as complete radiologic response in lymph nodes and extralymphatic sites with target nodes/nodal masses regressing to ≤ 1.5 centimeters (cm) in longest transverse diameter (LDi) and no extralymphatic sites of disease; absence of non-measured lesion; organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, immunohistochemistry (IHC) negative.

Objective Response Rate (ORR), Complete Response (CR) or Partial Response (PR), as Determined by Investigator and IRC Using Lugano Response Criteria (LRC) for Malignant Lymphoma

ORR=CR+PR. Per LRC: CR by PET-CT: complete MR in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass; no new lesions, no FDG-avid disease in bone marrow; CR by CT: complete radiologic response in lymph nodes and extralymphatic sites with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi, no extralymphatic disease; absence of non-measured lesion; organ enlargement regressing to normal; no new lesions; normal bone marrow; PR by PET-CT: partial MR in lymph nodes and extralymphatic sites with a score of 4 or 5 with reduced uptake compared with baseline + residual masses of any size; no new lesions, residual uptake higher than in normal bone marrow but reduced compared with baseline; PR by CT: ≥ 50% decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 target nodes and extranodal sites; non-measured lesion absent/normal, regressed, but no increase; spleen regressed by >50 % in length beyond normal; no new lesions.

CRR, as Determined by IRC Using International Working Group (IWG) Response Criteria for Non-Hodgkin's Lymphoma (NHL) 1999 Guidelines

CRR was assessed according to the IWG Response Criteria for NHL 1999 guidelines and included CR and CR unconfirmed (CRu). CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by > 75 % but still >1.5 cm in size, and indeterminate bone marrow assessment.

CRR, as Determined by the Investigator Using Lugano Response Criteria for Malignant Lymphoma

Per LRC, CR based on PET-CT was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass, on 5-point scale (5PS), where, 1= no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake > mediastinum but ≤ liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of FDG-avid disease in bone marrow. Per LRC, CR based on CT was defined as complete radiologic response in lymph nodes and extralymphatic sites with target nodes/nodal masses regressing to ≤ 1.5 centimeters (cm) in longest transverse diameter (LDi) and no extralymphatic sites of disease; absence of non-measured lesion; organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative.

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

AE: any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of causal attribution. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. New disease, exacerbation of existing disease, recurrence of an intermittent medical condition not present at baseline, any deterioration in a laboratory value or other clinical test associated with symptoms or leading to a change in study/concomitant treatment or discontinuation from study drug as well as events related to protocol-mandated interventions are considered AEs. SAEs: any event that met any of these criteria: fatal, life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, medically significant or required intervention to prevent any of the outcomes listed here.

Number of Participants With Rituximab Administration-related Reactions (ARRs)

Adverse events occurring within 24 hours after administration of rituximab (rituximab IV or rituximab SC) and considered related to the study drug, were considered as ARRs. ARRs could present with one or more of the following symptoms: allergic reaction, arthralgia, bronchospasm, chills, cough, dizziness, dyspnoea, headache, hypertension, hypotension, myalgia, nausea, pruritus, pyrexia, rash, tachycardia, urticaria, vomiting.

Number of Participants Positive for Anti-drug Antibodies (ADAs) to Rituximab

Reported here is the number of participants who had a positive ADA assay result at baseline or post-baseline. The post-baseline results are divided in treatment-enhanced ADAs and treatment-induced ADAs. Treatment-enhanced ADAs are participants with a positive ADA result at baseline who had one or more post-baseline titer results that was at least 0.60 titer unit greater than the baseline titer result. Treatment-induced ADAs include participants with negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result.

Number of Participants Positive for Anti-rHuPH20 Antibodies

Reported here is the number of participants who had a positive anti-rHuPH20 antibody assay result at baseline or post-baseline. The post-baseline results are divided in treatment-enhanced anti-rHuPH20 antibodies and treatment-induced anti-rHuPH20 antibodies. Treatment-enhanced anti-rHuPH20 antibodies are participants with a positive anti-rHuPH20 antibody result at baseline who had one or more post-baseline titer results that was at least 0.60 titer unit greater than the baseline titer result. Treatment-induced anti-rHuPH20 antibodies include participants with negative or missing baseline anti-rHuPH20 antibody result(s) and at least one positive post-baseline anti-rHuPH20 antibody result.

Full Information

NCT ID

NCT04660799

First Posted

November 25, 2020

Last Updated

September 29, 2023

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT04660799

Brief Title

A Study on Pharmacokinetics (PK), Efficacy and Safety of Subcutaneous (SC) Versus Intravenous (IV) Rituximab, in Combination With CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) in Previously Untreated Participants With CD20 Positive Diffuse Large B-Cell Lymphoma (DLBCL)

Official Title

A Phase II Comparative, Open-Label, Randomized, Multicenter, China-Only Study to Investigate the Pharmacokinetics, Efficacy and Safety of Subcutaneous Rituximab Versus Intravenous Rituximab Both in Combination With CHOP in Previously Untreated Patients With CD20 Positive Diffuse Large B Cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

February 24, 2021 (Actual)

Primary Completion Date

May 23, 2022 (Actual)

Study Completion Date

October 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

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

5. Study Description

Brief Summary

This is a multicenter China-only study to investigate the PK, efficacy and safety of SC rituximab versus IV rituximab, both in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) in previously untreated participants with CD20 positive DLBCL. Participants will be randomized to receive eight cycles of rituximab SC or rituximab IV combined with six or eight cycles of standard CHOP chemotherapy. After the end of study treatment, participants will be followed-up every 3 months for 6 months.

6. Conditions and Keywords

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

Lymphoma, Large B-Cell, Diffuse

Keywords

Mabthera, Rituximab, SC, Subcutaneous, DLBCL

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rituximab IV+CHOP

Arm Type

Active Comparator

Arm Description

Participants will receive 8 cycles of IV rituximab in combination with 6 or 8 cycles of CHOP chemotherapy administered every 3 weeks.

Arm Title

Rituximab SC+CHOP

Arm Type

Experimental

Arm Description

Participants will receive 1 cycle of IV plus 7 cycles of SC rituximab in combination with 6 or 8 cycles of CHOP chemotherapy administered every 3 weeks.

Intervention Type

Drug

Intervention Name(s)

Rituximab IV

Other Intervention Name(s)

MabThera

Intervention Description

Rituximab will be administered intravenously through Cycle 1-8 at a standard dose of 375 mg/m^2 (milligram per square meter).

Intervention Type

Drug

Intervention Name(s)

Rituximab SC

Other Intervention Name(s)

MabThera

Intervention Description

Rituximab will be administered subcutaneously through Cycle 2-8 at a dose of 1400 milligram (mg).

Intervention Type

Drug

Intervention Name(s)

Rituximab IV

Other Intervention Name(s)

MabThera

Intervention Description

Rituximab will be administered intravenously in Cycle 1 at a standard dose of 375 mg/m^2.

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Intervention Description

Cyclophosphamide will be administered IV at a dose of 750 mg/m^2

Intervention Type

Drug

Intervention Name(s)

Doxorubicin

Intervention Description

Doxorubicin will be administered IV at a dose of 50 mg/m^2

Intervention Type

Drug

Intervention Name(s)

Vincristine

Intervention Description

Vincristine will be administered IV at a dose of 1.4 mg/m^2

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

Prednisone will be administered orally at a dose of 100 mg/day

Intervention Type

Drug

Intervention Name(s)

Paracetamol

Intervention Description

All participants are required to receive 1000 mg oral paracetamol as premedication prior to starting each infusion of rituximab

Intervention Type

Drug

Intervention Name(s)

Diphenhydramine hydrochloride or alternative antihistamine

Intervention Description

All participants are required to receive 50-100 mg oral diphenhydramine hydrochloride or alternative antihistamine as premedication prior to starting each infusion of rituximab

Primary Outcome Measure Information:

Title

Subcutaneous Serum Rituximab Trough Concentration (Ctrough SC) and Intravenous Serum Rituximab Trough Concentration (Ctrough IV)

Description

Time Frame

At Cycle 7 (one cycle=21 days), 21 days after study treatment administration, up to 21 weeks

Secondary Outcome Measure Information:

Title

Observed SC and IV Rituximab Area Under the Curve (AUCsc and AUCiv)

Description

Time Frame

During Cycle 7 (one cycle=21 days): pre-dose, within 15 minutes of end of infusion, 24 hours post-dose, Days 3, 7, 15, 21, up to 21 weeks

Title

Maximum Observed Serum Concentration (Cmax) of Rituximab

Time Frame

At Cycles 2 and 7 (one cycle=21 days): pre-dose, within 15 minutes of end of infusion, 24 hours post-dose, Days 3, 7, 15, 21, up to 21 weeks

Title

Time to Cmax (Tmax) of Rituximab

Time Frame

At Cycles 2 and 7 (one cycle=21 days): pre-dose, within 15 minutes of end of infusion, 24 hours post-dose, Days 3, 7, 15, 21, up to 21 weeks

Title

Trough Serum Concentration (Ctrough) of Rituximab

Description

Ctrough was measured at Cycle 2 and Cycle 7, 21 days after study treatment administration for each cycle (pre-dose of Cycle 3 and Cycle 8, respectively).

Time Frame

At Cycles 2 and 7 (one cycle=21 days), 21 days after study treatment administration, up to 21 weeks

Title

Area Under the Curve (AUC) of Rituximab

Description

AUC is the area under the serum concentration curve over the dosing interval of 21 days during Cycle 2 and Cycle 7.

Time Frame

During Cycles 2 and 7 (one cycle=21 days): pre-dose, within 15 minutes of end of infusion, 24 hours post-dose, Days 3, 7, 15, 21, up to 21 weeks

Title

Complete Response Rate (CRR) as Determined by the Independent Review Committee (IRC) Using Lugano Response Criteria (LRC) for Malignant Lymphoma

Description

Time Frame

6-8 weeks after the last dose of study treatment or 4-8 weeks after last dose of study treatment for early discontinuation (up to approximately 32 weeks)

Title

Objective Response Rate (ORR), Complete Response (CR) or Partial Response (PR), as Determined by Investigator and IRC Using Lugano Response Criteria (LRC) for Malignant Lymphoma

Description

Time Frame

6-8 weeks after the last dose of study treatment or 4-8 weeks after last dose of study treatment for early discontinuation (up to approximately 32 weeks)

Title

CRR, as Determined by IRC Using International Working Group (IWG) Response Criteria for Non-Hodgkin's Lymphoma (NHL) 1999 Guidelines

Description

Time Frame

6-8 weeks after the last dose of study treatment or 4-8 weeks after last dose of study treatment for early discontinuation (up to approximately 32 weeks)

Title

CRR, as Determined by the Investigator Using Lugano Response Criteria for Malignant Lymphoma

Description

Time Frame

6-8 weeks after the last dose of study treatment or 4-8 weeks after last dose of study treatment for early discontinuation (up to approximately 32 weeks)

Title

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Description

Time Frame

AEs were reported up to 28 days after the last dose (up to approximately 7 months), and SAEs were reported up to 6 months after the last dose of study treatment (up to approximately 1 year)

Title

Number of Participants With Rituximab Administration-related Reactions (ARRs)

Description

Time Frame

Up to 24 hours after the last dose of study treatment (up to approximately 24 weeks)

Title

Number of Participants Positive for Anti-drug Antibodies (ADAs) to Rituximab

Description

Time Frame

From baseline up to 6 months after the last dose of study treatment (up to approximately 1 year)

Title

Number of Participants Positive for Anti-rHuPH20 Antibodies

Description

Time Frame

From baseline up to 6 months after the last dose of study treatment (up to approximately 1 year)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Previously untreated CD20 positive diffuse large B-cell lymphoma (DLBCL) Participants with an International Prognostic Index (IPI) score of 1 to 5 or IPI score of 0 with bulky disease, defined as one lesion >/=7.5 cm At least one bi-dimensionally measurable lesion defined as >/=1.5 cm in its largest dimension on CT scan Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 Left ventricular ejection fraction (LVEF) >/=50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram A negative serum pregnancy test or a negative urine pregnancy test within 7 days prior to study treatment For men who are not surgically sterile, agreement to use a barrier method of contraception during the treatment period and until >/=12 months after the last dose of rituximab SC or rituximab IV or according to institutional guidelines for CHOP chemotherapy, whichever is longer, and agreement to request that their partners use an additional method of contraception For women of reproductive potential who are not surgically sterile, agreement to use adequate methods of contraception during the treatment period and until >/=12 months after the last dose of rituximab SC or rituximab IV or according to institutional guidelines for CHOP chemotherapy, whichever is longer Adequate hematologic function confirmed within 14 days prior to randomization Exclusion Criteria: Transformed non-Hodgkin's lymphoma (NHL) or types of NHL other than DLBCL and its subtypes according to World Health Organization classification History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation or surgery for diagnosis Prior treatment with cytotoxic drugs or rituximab for another condition (e.g.,rheumatoid arthritis) or prior use of an anti-CD20 antibody Current or recent treatment with another investigational drug or participation in another investigational therapeutic study Ongoing corticosteroid use (>30 mg/day of prednisone or equivalent) Primary CNS lymphoma, blastic variant of mantle cell lymphoma, or histologic evidence of transformation to a Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, and primary cutaneous DLBCL History of other malignancy that could affect compliance with the protocol or interpretation of results Evidence of significant, uncontrolled concomitant diseases including but not limited to significant cardiovascular disease or pulmonary disease Any of the following abnormal laboratory values: creatinine >1.5 upper limit of normal (ULN), aspartate aminotransferase (AST) / alanine aminotransferase (ALT) >2.5ULN, total bilirubin >1.5ULN, prothrombin time - international normalized ratio (PT-INR) / partial thromboplastin time (PTT) / activated partial thromboplastin time (aPTT)>1.5ULN Positive test results for chronic hepatitis B (HBV) and or hepatitis C (HCV) infection; Participants with occult or prior HBV infection (defined as negative HBsAg and positive total hepatitis B core antibody [HBcAb]) may be included if HBV DNA is undetectable; Participants positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA Known history of human immunodeficiency virus (HIV)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

Facility Name

Peking University Third Hospital

City

Beijing

ZIP/Postal Code

100191

Country

China

Facility Name

The First Hospital of Jilin University

City

Changchun City

ZIP/Postal Code

130021

Country

China

Facility Name

Fujian Provincial Cancer Hospital

City

Fuzhou City

ZIP/Postal Code

350014

Country

China

Facility Name

Harbin Medical University Cancer Hospital

City

Harbin

ZIP/Postal Code

150081

Country

China

Facility Name

The 1st Affiliated Hospital of Nanchang Unversity

City

Nanchang

ZIP/Postal Code

330019

Country

China

Facility Name

Tianjin Medical University Cancer Institute & Hospital

City

Tianjing

ZIP/Postal Code

300060

Country

China

Facility Name

Union Hospital Tongji Medical College Huazhong University of Science and Technology

City

Wuhan City

ZIP/Postal Code

430023

Country

China

Facility Name

The First Affiliated Hospital of Xian Jiao Tong University

City

Xi'an City

ZIP/Postal Code

710061

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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