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)
CompletedPhase 2Results postedLast updated 12 October 2023
What this trial tests
Phase 2 trial testing Rituximab IV in Lymphoma, Large B-Cell, Diffuse in 50 participants. Completed in 11 October 2022.
Adults 18 to 80, any sex, with Lymphoma, Large B-Cell, Diffuse. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Subcutaneous Serum Rituximab Trough Concentration (Ctrough SC) and Intravenous Serum Rituximab Trough Concentration (Ctrough IV)Primary· At Cycle 7 (one cycle=21 days), 21 days after study treatment administration, up to 21 weeks
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.
Group
Value
95% CI
Rituximab IV+CHOP
90.7
± 21.1
Rituximab SC+CHOP
137.4
± 36.3
Observed SC and IV Rituximab Area Under the Curve (AUCsc and AUCiv)Secondary· 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
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.
Group
Value
95% CI
Rituximab IV+CHOP
3050.7
± 17.8
Rituximab SC+CHOP
3806.7
± 27.2
Maximum Observed Serum Concentration (Cmax) of RituximabSecondary· 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
Cycle 2
Group
Value
95% CI
Rituximab IV+CHOP
200
± 18.3
Rituximab SC+CHOP
144
± 29.6
Cycle 7
Group
Value
95% CI
Rituximab IV+CHOP
255
± 14.6
Rituximab SC+CHOP
228
± 28.3
Time to Cmax (Tmax) of RituximabSecondary· 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
Cycle 2
Group
Value
95% CI
Rituximab IV+CHOP
0.14
0.09 – 0.94
Rituximab SC+CHOP
5.42
1.88 – 13.90
Cycle 7
Group
Value
95% CI
Rituximab IV+CHOP
0.16
0.10 – 1.03
Rituximab SC+CHOP
1.99
1.84 – 6.91
Trough Serum Concentration (Ctrough) of RituximabSecondary· At Cycles 2 and 7 (one cycle=21 days), 21 days after study treatment administration, up to 21 weeks
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).
Cycle 2
Group
Value
95% CI
Rituximab IV+CHOP
43.2
± 26.5
Rituximab SC+CHOP
63.5
± 36.9
Cycle 7
Group
Value
95% CI
Rituximab IV+CHOP
90.7
± 21.1
Rituximab SC+CHOP
137
± 36.3
Area Under the Curve (AUC) of RituximabSecondary· 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
AUC is the area under the serum concentration curve over the dosing interval of 21 days during Cycle 2 and Cycle 7.
Cycle 2
Group
Value
95% CI
Rituximab IV+CHOP
1730
± 21.5
Rituximab SC+CHOP
2130
± 31.1
Cycle 7
Group
Value
95% CI
Rituximab IV+CHOP
3050
± 17.8
Rituximab SC+CHOP
3810
± 27.2
Complete Response Rate (CRR) as Determined by the Independent Review Committee (IRC) Using Lugano Response Criteria (LRC) for Malignant LymphomaSecondary· 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)
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 i
Group
Value
95% CI
Rituximab IV+CHOP
62.5
40.59 – 81.20
Rituximab SC+CHOP
80.8
60.65 – 93.45
Objective Response Rate (ORR), Complete Response (CR) or Partial Response (PR), as Determined by Investigator and IRC Using Lugano Response Criteria (LRC) for Malignant LymphomaSecondary· 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)
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 baseli
Investigator
Group
Value
95% CI
Rituximab IV+CHOP
70.8
48.91 – 87.38
Rituximab SC+CHOP
88.5
69.85 – 97.55
IRC
Group
Value
95% CI
Rituximab IV+CHOP
66.7
44.68 – 84.37
Rituximab SC+CHOP
80.8
60.65 – 93.45
CRR, as Determined by IRC Using International Working Group (IWG) Response Criteria for Non-Hodgkin's Lymphoma (NHL) 1999 GuidelinesSecondary· 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)
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.
Group
Value
95% CI
Rituximab IV+CHOP
58.3
36.64 – 77.89
Rituximab SC+CHOP
65.4
44.33 – 82.79
CRR, as Determined by the Investigator Using Lugano Response Criteria for Malignant LymphomaSecondary· 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)
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 reg
Group
Value
95% CI
Rituximab IV+CHOP
58.3
36.64 – 77.89
Rituximab SC+CHOP
76.9
56.35 – 91.03
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Secondary· 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)
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 stu
AEs
Group
Value
95% CI
Rituximab IV+CHOP
24
Rituximab SC+CHOP
26
SAEs
Group
Value
95% CI
Rituximab IV+CHOP
11
Rituximab SC+CHOP
8
Number of Participants With Rituximab Administration-related Reactions (ARRs)Secondary· Up to 24 hours after the last dose of study treatment (up to approximately 24 weeks)
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.
Group
Value
95% CI
Rituximab IV+CHOP
6
Rituximab SC+CHOP
7
Adverse events — posted to ClinicalTrials.gov
Time frame: Non-serious adverse events (NSAEs) were reported up to 28 days after the last dose (up to approximately 7 months). Serious adverse events (SAEs) and adverse events of special interest (AESIs) were reported up to 6 months after the last dose of study treatment (up to approximately 1 year).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT01200758 — A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicul
· Phase 3
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 12 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04660799.