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| ID | Type | Description | Link |
|---|---|---|---|
| GEN415 | Other Identifier | Genmab |
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The purpose of this trial is to determine the effect of ofatumumab in patients with Diffused Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapsed after autologous transplant
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ofatumumab | Experimental | 8 weekly intra-venous (I.V.) infusions, 1 x 300mg and 7 x 1000mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ofatumumab | Drug | 8 weekly intra-venous (i.v.) infusions, 1 x 300mg and 7 x 1000mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Objective Response | Objective response of ofatumumab treatment was assessed according to the "revised response criteria for malignant lymphoma." Participants with objective response were defined as responders with complete remission (CR) or partial remission (PR) of disease. CR is defined as the disappearance of all evidence of disease, and PR is defined as the regression of measurable disease with no new sites of disease. | 6-month period from start of treatment (up to Week 24) |
| Number of Participants Classified as Responders and Non-responders for Objective Response | According to the "revised response criteria for malignant lymphoma," responders included participants with CR and PR, and non-responders included participants with stable disease (SD) and progressive disease (PD). Participants not evaluable (NE) were also considered to be non-responders. PD is defined as any new lesion or an increase by more than or equal to 50% of previously involved sites from baseline. SD is defined as failure to attain CR, PR, or PD. | 6-month period from start of treatment (up to Week 24) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | The duration of response was defined as the time from the initial response (CR or PR) to the time of relapse, progression, or death. If the participant was lost to follow-up, the endpoint was censored, and the censoring date was the date of the last attended visit at which the endpoint was assessed. | From date of start of treatment to 2 years or withdrawal |
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Inclusion Criteria:
Patients with DLBCL
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | London | London | EC1M 6BQ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24032456 | Derived | Coiffier B, Radford J, Bosly A, Martinelli G, Verhoef G, Barca G, Davies A, Decaudin D, Gallop-Evans E, Padmanabhan-Iyer S, Van Eygen K, Wu KL, Gupta IV, Lin TS, Goldstein N, Jewell RC, Winter P, Lisby S; 415 study investigators. A multicentre, phase II trial of ofatumumab monotherapy in relapsed/progressive diffuse large B-cell lymphoma. Br J Haematol. 2013 Nov;163(3):334-42. doi: 10.1111/bjh.12537. Epub 2013 Aug 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ofatumumab | Participants received 8 weekly intravenous (iv) infusions of ofatumumab: first infusion of 300 milligrams (mg), followed by 7 infusions of 1000 mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ofatumumab | Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Objective Response | Objective response of ofatumumab treatment was assessed according to the "revised response criteria for malignant lymphoma." Participants with objective response were defined as responders with complete remission (CR) or partial remission (PR) of disease. CR is defined as the disappearance of all evidence of disease, and PR is defined as the regression of measurable disease with no new sites of disease. | Full Analysis Set (FAS): all participants who were exposed to study drug irrespective of their compliance to the planned course of treatment | Posted | Number | participants | 6-month period from start of treatment (up to Week 24) |
|
Adverse events (AE) were reported from first infusion (Week 0) to Month 24 of follow-up (FU)/withdrawal (treatment and FU). Serious AEs were reported through Month 60 (treatment, FU, and extended FU).
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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 | Ofatumumab | Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disease progression | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C527517 | ofatumumab |
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| Progression-free Survival (PFS) | PFS was defined as the time from treatment start until progression or death. | From date of start of treatment to 2 years or withdrawal |
| Time to Next Diffuse Large B-Cell Lymphoma (DLBCL) Therapy | Time to next DLBCL therapy was defined as the time from the first infusion date to the time of the first administration of the next DLBCL treatment other than ofatumumab. If the participants were lost to follow-up, the endpoint was censored, and the censoring date was the date of the last attended visit at which the endpoint was assessed. | From date of start of treatment to 5 years or withdrawal |
| Overall Survival (OS) | Overall survival is defined as the time from first infusion to death. Overall survival was a secondary endpoint in the study. However, since many participants withdrew from the study after developing disease progression overall survival could not be reliably estimated. | From date of start of treatment to 5 years or withdrawal |
| Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18 | HAHA are indicators of immune response to ofatumumab. Blood samples were collected from participants at Visits 1, 12, 13, 14, and 18 and analyzed in batches. The number of participants with positive results at each visit is reported. | Screening visit (=<14 days before treatment start), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), and Visit 18 (Month 24) |
| Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits | B cells (CD45+CD19+ and CD45+CD20+) were measured in peripheral blood samples by flow cytometry. Percent change from Baseline = (value at the indicated visits minus the value at Baseline divided by the value at Baseline) * 100. | Baseline and Visit 10 (Week 8), Visit 11 (Week 11), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), Visit 15 (Month 15), Visit 16 (Month 18), Visit 17 (Month 21), Visit 18 (Month 24), Visit 19 (Month 30), Visit 20 (Month 36) |
| Number of Participants Who Experienced at Least One Adverse Event (AE) | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. The protocol-defined AE reporting period was from the first infusion (Visit 2/Week 0) to Visit 18 (Month 24 of follow-up) or time of withdrawal (treatment and follow-up). | Time frame is from date of start of treatment to 2 years or withdrawal |
| Percent Change From Screening in Complement (CH50) Levels | CH50 was mistakenly registered as an outcome measure with the protocol record. Samples were not collected, and no analysis will take place. Thus, no data will be reported for this outcome measure. | Screening and post-baseline visits (last visit was to occur 24 months post first dose) |
| AUC(0-inf) and AUC(0-168) for Ofatumumab at the Eighth Infusion | AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-168) is the AUC from the start of infusion to 168 hours after the start of the infusion; AUC(0-inf) is the AUC from the start of infusion extrapolated to infinity. | Visit 9 (Week 7; up to 11 months after last dose) |
| Cmax and Ctrough for Ofatumumab at the First and Eighth Infusions | Cmax is defined as the maximum concentration of drug in serum samples. Ctrough is defined as the minimum observed concentration prior to the start of the next dose. No drug is present prior to the first infusion; therefore, there are no Ctrough results for the first dose. | Visit 2 (Week 0) and Visit 9 (Week 7) |
| Half-life (T1/2) for Ofatumumab at the Eighth Infusion | t1/2 is defined as terminal half-life and is the time required for the amount of drug in the body to decrease by half. | Visit 9 (Week 7; up to 11 months after last dose) |
| Clearance (CL) of Ofatumumab at the Eighth Infusion | CL is the clearance of drug from serum, which is defined as the volume of serum from which the drug is cleared per unit time. | Visit 9 (Week 7; up to 11 months after last dose) |
| Volume of Distribution at Steady State (Vss) of Ofatumumab at the Eighth Infusion | Vss is the volume of distribution at steady state of ofatumumab. | Visit 9 (Week 7; up to 11 months after the last dose) |
| Participant Refusal |
|
| Death |
|
| Received Alternate Anticancer Therapy |
|
| Took Prohibited Medication |
|
| Withdrew Consent |
|
| Insurance Expired |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Number of Participants with the Indicated Prior Therapy | Study participants had to have either prior autologous stem cell transplant (ASCT) or had to be ineligible for ASCT to be eligible for inclusion. | Number | participants |
|
|
|
|
| Primary | Number of Participants Classified as Responders and Non-responders for Objective Response | According to the "revised response criteria for malignant lymphoma," responders included participants with CR and PR, and non-responders included participants with stable disease (SD) and progressive disease (PD). Participants not evaluable (NE) were also considered to be non-responders. PD is defined as any new lesion or an increase by more than or equal to 50% of previously involved sites from baseline. SD is defined as failure to attain CR, PR, or PD. | FAS | Posted | Number | participants | 6-month period from start of treatment (up to Week 24) |
|
|
|
| Secondary | Duration of Response | The duration of response was defined as the time from the initial response (CR or PR) to the time of relapse, progression, or death. If the participant was lost to follow-up, the endpoint was censored, and the censoring date was the date of the last attended visit at which the endpoint was assessed. | FAS. Only participants with CR or PR were analyzed. | Posted | Median | 95% Confidence Interval | months | From date of start of treatment to 2 years or withdrawal |
|
|
|
| Secondary | Progression-free Survival (PFS) | PFS was defined as the time from treatment start until progression or death. | FAS | Posted | Median | 95% Confidence Interval | months | From date of start of treatment to 2 years or withdrawal |
|
|
|
| Secondary | Time to Next Diffuse Large B-Cell Lymphoma (DLBCL) Therapy | Time to next DLBCL therapy was defined as the time from the first infusion date to the time of the first administration of the next DLBCL treatment other than ofatumumab. If the participants were lost to follow-up, the endpoint was censored, and the censoring date was the date of the last attended visit at which the endpoint was assessed. | FAS | Posted | Median | 95% Confidence Interval | months | From date of start of treatment to 5 years or withdrawal |
|
|
|
| Secondary | Overall Survival (OS) | Overall survival is defined as the time from first infusion to death. Overall survival was a secondary endpoint in the study. However, since many participants withdrew from the study after developing disease progression overall survival could not be reliably estimated. | FAS | Posted | From date of start of treatment to 5 years or withdrawal |
|
|
| Secondary | Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18 | HAHA are indicators of immune response to ofatumumab. Blood samples were collected from participants at Visits 1, 12, 13, 14, and 18 and analyzed in batches. The number of participants with positive results at each visit is reported. | FAS. Data are provided for the number of participants attending each visit. | Posted | Number | participants | Screening visit (=<14 days before treatment start), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), and Visit 18 (Month 24) |
|
|
|
| Secondary | Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits | B cells (CD45+CD19+ and CD45+CD20+) were measured in peripheral blood samples by flow cytometry. Percent change from Baseline = (value at the indicated visits minus the value at Baseline divided by the value at Baseline) * 100. | FAS. Data are provided for the number of participants attending each visit. | Posted | Median | Full Range | percent change in cells | Baseline and Visit 10 (Week 8), Visit 11 (Week 11), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), Visit 15 (Month 15), Visit 16 (Month 18), Visit 17 (Month 21), Visit 18 (Month 24), Visit 19 (Month 30), Visit 20 (Month 36) |
|
|
|
| Secondary | Number of Participants Who Experienced at Least One Adverse Event (AE) | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. The protocol-defined AE reporting period was from the first infusion (Visit 2/Week 0) to Visit 18 (Month 24 of follow-up) or time of withdrawal (treatment and follow-up). | FAS | Posted | Number | participants | Time frame is from date of start of treatment to 2 years or withdrawal |
|
|
|
| Secondary | Percent Change From Screening in Complement (CH50) Levels | CH50 was mistakenly registered as an outcome measure with the protocol record. Samples were not collected, and no analysis will take place. Thus, no data will be reported for this outcome measure. | FAS | Posted | Screening and post-baseline visits (last visit was to occur 24 months post first dose) |
|
|
| Secondary | AUC(0-inf) and AUC(0-168) for Ofatumumab at the Eighth Infusion | AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-168) is the AUC from the start of infusion to 168 hours after the start of the infusion; AUC(0-inf) is the AUC from the start of infusion extrapolated to infinity. | FAS. Data are provided for the number of participants attending each visit for whom the parameter value could be calculated. Participants contributing AUC(0-inf) data also contributed AUC(0-168) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms*hour/milliliter (µg.h/mL) | Visit 9 (Week 7; up to 11 months after last dose) |
|
|
|
| Secondary | Cmax and Ctrough for Ofatumumab at the First and Eighth Infusions | Cmax is defined as the maximum concentration of drug in serum samples. Ctrough is defined as the minimum observed concentration prior to the start of the next dose. No drug is present prior to the first infusion; therefore, there are no Ctrough results for the first dose. | FAS. Data are provided for the number of participants attending each visit. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (µg/mL) | Visit 2 (Week 0) and Visit 9 (Week 7) |
|
|
|
| Secondary | Half-life (T1/2) for Ofatumumab at the Eighth Infusion | t1/2 is defined as terminal half-life and is the time required for the amount of drug in the body to decrease by half. | FAS. Data are provided for the number of participants at each visit for whom the parameter could be calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Visit 9 (Week 7; up to 11 months after last dose) |
|
|
|
| Secondary | Clearance (CL) of Ofatumumab at the Eighth Infusion | CL is the clearance of drug from serum, which is defined as the volume of serum from which the drug is cleared per unit time. | FAS. Data are presented for the number of participants at each visit for whom the parameter can be calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | milliliters per hour (mL/h) | Visit 9 (Week 7; up to 11 months after last dose) |
|
|
|
| Secondary | Volume of Distribution at Steady State (Vss) of Ofatumumab at the Eighth Infusion | Vss is the volume of distribution at steady state of ofatumumab. | FAS. Data are presented for the number of participants attending each visit for whom the parameter can be calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters | Visit 9 (Week 7; up to 11 months after the last dose) |
|
|
|
| 33 |
| 81 |
| 68 |
| 81 |
| Pyrexia | General disorders | Systematic Assessment |
|
| Infusion related reaction | General disorders | Systematic Assessment |
|
| Multi-organ failure | General disorders | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| Central line infection | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Septic shock | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | Systematic Assessment |
|
| Cholangitis acute | Hepatobiliary disorders | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | Systematic Assessment |
|
| Hepatitis acute | Hepatobiliary disorders | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | Systematic Assessment |
|
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Neurological symptom | Nervous system disorders | Systematic Assessment |
|
| Paraparesis | Nervous system disorders | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Eyelid ptosis | Endocrine disorders | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Oedema peripheral | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Asthenia | General disorders | Systematic Assessment |
|
| Disease progression | General disorders | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Blood creatinine increased | Investigations | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| Non-responders with PD |
|
| Non-responders with NE |
|
| Title | Measurements |
|---|---|
|
| Visit 14 (Month 12), n=16 |
|
| Visit 18 (Month 24), n=8 |
|
| End of Trial/Withdrawal, n=43 |
|
|
| CD45+CD19+, Visit 13 (Month 9), n=15 |
|
| CD45+CD19+, Visit 14 (Month 12), n=13 |
|
| CD45+CD19+, Visit 15 (Month 15), n=12 |
|
| CD45+CD19+, Visit 16 (Month 18), n=8 |
|
| CD45+CD19+, Visit 17 (Month 21), n=8 |
|
| CD45+CD19+, Visit 18 (Month 24), n=7 |
|
| CD45+CD19+, Visit 19 (Month 30), n=2 |
|
| CD45+CD19+, Visit 20 (Month 36), n=2 |
|
| CD45+CD20+, Visit 10 (Week 8), n=42 |
|
| CD45+CD20+, Visit 11 (Week 11), n=29 |
|
| CD45+CD20+, Visit 12 (Month 6), n=18 |
|
| CD45+CD20+, Visit 13 (Month 9), n=15 |
|
| CD45+CD20+, Visit 14 (Month 12), n=13 |
|
| CD45+CD20+, Visit 15 (Month 15), n=12 |
|
| CD45+CD20+, Visit 16 (Month 18), n=8 |
|
| CD45+CD20+, Visit 17 (Month 21), n=8 |
|
| CD45+CD20+, Visit 18 (Month 24), n=5 |
|
| CD45+CD20+, Visit 19 (Month 30), n=2 |
|
| CD45+CD20+, Visit 20 (Month 36), n=2 |
|
|