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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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The primary objective of the current study is to demonstrate the equivalent efficacy of rituximab (DRL_RI) and MabThera® in subjects with Low Tumor Burden Follicular Lymphoma (LTB-FL).
Also evaluated by Pharmacokinetic, safety, and immunogenicity assessment between a proposed biosimilar (DRL_RI) and the RMP, as an component of clinical study program, and collectively providing the evidence of biosimilarity.
The study will compare the safety and efficacy of DRL_RI vs MabThera in patients with Low Tumor Burden Follicular Lymphoma (LTB-FL). The primary objective is to establish comparative efficacy as measured by ORR up to week 28
It is planned to randomise approx. 312 subjects at approximately ≥ 130 study sites worldwide. Subjects with LTB-FL will be randomized to receive either DRL_RI or MabThera®. Till date, 68 patients have been randomized for the study.
The study specific objectives are mentioned below:
Primary Objective:
• To demonstrate the equivalent efficacy of DRL_RI (biosimilar rituximab) and MabThera in subjects with CD20-positive, LTB FL, as measured by overall response rate (ORR) up to Week 28 evaluated in accordance with Cheson, 1999 response criteria for Non-Hodgkin's Lymphomas.
Secondary Objectives:
Exploratory Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: DRL_RI | Experimental | DRL_RI (rituximab-Dr. Reddy's Lab) for infusion 375 mg/m2 administered via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36 |
|
| Arm B: MabThera® | Active Comparator | MabThera® for infusion 375 mg/m2 administered via IV infusion on Days 1, 8, 15, 22 and Week 12, 20, 28 and 36. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DRL_RI (Proposed rituximab biosimilar) | Biological | Proposed rituximab biosimilar, 100mg and 500mg, concentrate for solution for infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response Rate (BORR) for Low Tumor Burden Follicular Lymphoma | Best Overall Response Rate (BORR) is defined as the proportion of participants in each treatment group that achieved a best overall response of either Complete response (CR), unconfirmed Complete response (CRu) or Partial response (PR), up to Month 7 (Week 28) based on central radiology review in accordance with the Cheson, 1999 response criteria for Non-Hodgkin's Lymphomas. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization; unconfirmed Complete response (CRu): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with non-confirmed Bone marrow normalization; Partial Response (PR): ≥ 50 % decrease of sum of products of diameter(SPD) of all the target lesions; Overall Response (OR)=CR+CRu+PR. | Month 7 (Week 28) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | The overall response rate (ORR) is defined as proportion of participants in each treatment group achieved a complete response or partial response at week 12 and week 28 based on central radiology review in accordance with published response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization; unconfirmed Complete response (uCR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with non-confirmed Bone marrow normalization; Partial Response (PR): ≥ 50 % decrease of sum of products of diameter(SPD) of all the target lesions; Overall Response (OR)=CR+uCR+PR. |
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Inclusion Criteria:
Subject is Male or female subjects aged ≥18 years of age.
Subject is histologically confirmed, Grade 1-3a, previous ly untreated, CD20-pos itive.
Subject has Ann Arbor Stage II to IV and ECOG status of 0 to 1.
Subject has Low tumor burden follicular lymphoma as per Groupe d'Etude des Lymphomes Folliculaires (GELF) Criteria
Subject has at least 1 measurable tumor mass in 2 dimensions, and the mass must be:
Subject has Life expectancy ≥3 months.
If female subject, then subject should be non-pregnant, non-lactating.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eliso Sopia, MD | Parexel | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Oncology Institute of Hope and Innovation | Whittier | California | 90602 | United States | ||
| American Oncology Partners of Maryland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40421128 | Derived | Maharaj N, Uppada DR, Eswaraiah A, Kakkattu R, Reddy P, Kalenik VA, Belada D, Ramos AO, Kim JS, Baranau YV. Efficacy and safety of rituximab biosimilar (DRL_RI) versus MabThera(R) in low-tumor-burden follicular lymphoma: the FLINTER study. Ther Adv Med Oncol. 2025 May 24;17:17588359251339925. doi: 10.1177/17588359251339925. eCollection 2025. |
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All the assessments were performed as per the schedule of the assessments.
The trial was conducted at 4 sites in the United States from 15 May 2019 to 27 February 2023. The final participant was examined or received an intervention for the purposes of final collection of data for the primary outcome on 28 September 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: DRL_RI | Randomized participants were administered rituximab biosimilar-Dr. Reddy's Lab (DRL_RI) 375mg/m^2 via intravenous (IV) infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36. |
| FG001 | Arm B: MabThera® |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 27, 2021 | Sep 28, 2023 |
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Clinical Phase III, randomised, multicentre, double-blind study to demonstrate the equivalence of DRL_RI to MabThera® in subjects with previously untreated, LTB-FL.
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| MabThera® | Other | Reference product rituximab, 100mg and 500mg, concentrate for solution for infusion |
|
| Week 12, Week 28 |
| Complete Response Rate | Complete Response rate is defined as the proportion of participants in each treatment group who achieved complete response up to particular visit based on investigator assessment in accordance with the response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization. | Week 28 |
| Complete Response Rate as a Best Response | Complete Response Rate as a Best Response is defined as the proportion of participants in each treatment group that achieved the best complete response up to Week 28 based on central radiology review in accordance with the Cheson 1999, response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization. | Week 28 |
| Duration of Response (DOR) | Duration of response (DOR) defined as the time from date of the first documentation of tumor response (Complete Response, unconfirmed complete response or partial response) to the date of first documentation of progressive disease (PD) or to death due to any cause up to 52 weeks/ End of study (EOS). Progression is defined as per Cheson 1999, response criteria is: Target Nodal SPD Progression: at least one node must be abnormal, and the SPD of all nodes must increase by ≥ 50% from its nadir SPD. Target Extranodal SPD Progression: at least one extranodal lesion must be present and the SPD of all extranodal lesions must increase by ≥ 50% from its nadir SPD. Also, if a patient had any unequivocal progression in non-target lesions; and detection of any new nodal lesion (longest diameter [LDi] 15mm with an absolute increase of 5mm) his/her response was considered as Progressive disease. | Week 52 |
| Progression-free Survival (PFS) | Progression-free survival (PFS) is defined as the time from date of randomization to the date of documented progressive disease or death due to any cause. Progression is defined as per Cheson 1999, response criteria is: Target Nodal SPD Progression: at least one node must be abnormal, and the SPD of all nodes must increase by ≥ 50% from its nadir SPD. Target Extranodal SPD Progression: at least one extranodal lesion must be present and the SPD of all extranodal lesions must increase by ≥ 50% from its nadir SPD. Also, if a patient had any unequivocal progression in non-target lesions; and detection of any new nodal lesion (LDi 15mm with an absolute increase of 5mm) his/her response was considered as Progressive disease. | Week 52 |
| Overall Survival (OS) | The Overall survival (OS) defined as the time from date of randomization to the date of death from any cause up to 52 weeks or EOS. | Week 52 |
| Number of Participants With Adverse Events | The safety and tolerability of DRL_RI and MabThera® in participants with CD20-positive, LTB-FL was evaluated. | From Screening (Day -28 to -1) up to 52 weeks |
| Number of Participants With Positive Anti-drug Antibody (ADA) | The immunogenicity of the Proposed Rituximab Biosimilar (DRL_RI) with MabThera® among trial participants was compared. | On Day 1, Week 2, Week 3, Week 4, Week 12 post dose |
| Bethesda |
| Maryland |
| 20817 |
| United States |
| University of Tennessee Medical Center - Cancer Institute | Knoxville | Tennessee | 37920 | United States |
| Gulf coast Oncology Associates, PA | Houston | Texas | 77089 | United States |
Randomized participants were administered MabThera® 375 mg/m^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Intent to Treat (ITT) Analysis Set included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: DRL_RI | Randomized participants were administered DRL_RI 375 mg/m^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36 |
| BG001 | Arm B: MabThera® | Randomized participants were administered MabThera® 375 mg/m^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Best Overall Response Rate (BORR) for Low Tumor Burden Follicular Lymphoma | Best Overall Response Rate (BORR) is defined as the proportion of participants in each treatment group that achieved a best overall response of either Complete response (CR), unconfirmed Complete response (CRu) or Partial response (PR), up to Month 7 (Week 28) based on central radiology review in accordance with the Cheson, 1999 response criteria for Non-Hodgkin's Lymphomas. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization; unconfirmed Complete response (CRu): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with non-confirmed Bone marrow normalization; Partial Response (PR): ≥ 50 % decrease of sum of products of diameter(SPD) of all the target lesions; Overall Response (OR)=CR+CRu+PR. | The ITT Analysis Set included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 7 (Week 28) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) | The overall response rate (ORR) is defined as proportion of participants in each treatment group achieved a complete response or partial response at week 12 and week 28 based on central radiology review in accordance with published response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization; unconfirmed Complete response (uCR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with non-confirmed Bone marrow normalization; Partial Response (PR): ≥ 50 % decrease of sum of products of diameter(SPD) of all the target lesions; Overall Response (OR)=CR+uCR+PR. | The ITT Analysis Set included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of particpants | Week 12, Week 28 |
| ||||||||||||||||||||||||||||||
| Secondary | Complete Response Rate | Complete Response rate is defined as the proportion of participants in each treatment group who achieved complete response up to particular visit based on investigator assessment in accordance with the response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization. | The ITT Analysis Set included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 28 |
|
| |||||||||||||||||||||||||||||
| Secondary | Complete Response Rate as a Best Response | Complete Response Rate as a Best Response is defined as the proportion of participants in each treatment group that achieved the best complete response up to Week 28 based on central radiology review in accordance with the Cheson 1999, response criteria for malignant lymphoma. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization. | The ITT Analysis Set included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 28 |
|
| |||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | Duration of response (DOR) defined as the time from date of the first documentation of tumor response (Complete Response, unconfirmed complete response or partial response) to the date of first documentation of progressive disease (PD) or to death due to any cause up to 52 weeks/ End of study (EOS). Progression is defined as per Cheson 1999, response criteria is: Target Nodal SPD Progression: at least one node must be abnormal, and the SPD of all nodes must increase by ≥ 50% from its nadir SPD. Target Extranodal SPD Progression: at least one extranodal lesion must be present and the SPD of all extranodal lesions must increase by ≥ 50% from its nadir SPD. Also, if a patient had any unequivocal progression in non-target lesions; and detection of any new nodal lesion (longest diameter [LDi] 15mm with an absolute increase of 5mm) his/her response was considered as Progressive disease. | The ITT Analysis Set included all randomized participants. The number analyzed are the participants with complete response, unconfirmed complete response or partial response. | Posted | Median | 95% Confidence Interval | Weeks | Week 52 |
| ||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | Progression-free survival (PFS) is defined as the time from date of randomization to the date of documented progressive disease or death due to any cause. Progression is defined as per Cheson 1999, response criteria is: Target Nodal SPD Progression: at least one node must be abnormal, and the SPD of all nodes must increase by ≥ 50% from its nadir SPD. Target Extranodal SPD Progression: at least one extranodal lesion must be present and the SPD of all extranodal lesions must increase by ≥ 50% from its nadir SPD. Also, if a patient had any unequivocal progression in non-target lesions; and detection of any new nodal lesion (LDi 15mm with an absolute increase of 5mm) his/her response was considered as Progressive disease. | The ITT Analysis Set included all randomized participants. | Posted | Median | 95% Confidence Interval | Weeks | Week 52 |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | The Overall survival (OS) defined as the time from date of randomization to the date of death from any cause up to 52 weeks or EOS. | The ITT Analysis Set included all randomized participants. | Posted | Median | 95% Confidence Interval | Weeks | Week 52 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events | The safety and tolerability of DRL_RI and MabThera® in participants with CD20-positive, LTB-FL was evaluated. | The Safety Analysis Set (SAF) will include all the participants who have received at least one dose of study drug. The SAF will be used for safety analysis. | Posted | Count of Participants | Participants | From Screening (Day -28 to -1) up to 52 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive Anti-drug Antibody (ADA) | The immunogenicity of the Proposed Rituximab Biosimilar (DRL_RI) with MabThera® among trial participants was compared. | The ITT Analysis Set included all randomized participants. | Posted | Count of Participants | Participants | On Day 1, Week 2, Week 3, Week 4, Week 12 post dose |
|
|
From Screening (Day -28 to -1) up to 52 weeks
The SAF include all participants who have received at least 1 dose of study drug and will be used for safety analysis. The number of participants analyzed for safety analysis is different from ITT analysis population (ITT population was defined as all patients randomized). Two participants were randomized but did not receive the treatment with MabThera and therefore were not included in the SAF but included in ITT.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A: DRL_RI | Randomized participants were administered DRL_RI 375mg/m^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36. | 3 | 162 | 22 | 162 | 47 | 162 |
| EG001 | Arm B: MabThera® | Randomized participants were administered MabThera® 375 mg/m^2 via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36. | 2 | 153 | 21 | 153 | 49 | 153 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Lumbar hernia | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
| |
| Infusion-related reaction | Investigations | MedDRA (25.0) | Non-systematic Assessment |
| |
| Haematoma muscle | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Non-systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Non-systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Psychomotor hyperactivity | Nervous system disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head - Clinical Development | Dr. Reddy's Laboratories Ltd. | 91-40-4464-4000 | RI-01-006@drreddys.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 26, 2019 | Sep 28, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| Aboriginal/Torres Strait Islander |
|
| Unknown |
|
| Not Reported |
|
| Units | Counts |
|---|---|
| Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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