Trial · NCT01200758
A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma
NCT01200758, Phase 3, Completed, Hoffmann-La Roche; results first posted 2015-08-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma. Trials, record NCT01200758. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01200758
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma
- NCT number
- NCT01200758
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 410 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- Rituximab SC, Rituximab IV, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone/Prednisolone
- First posted
- 2010-09-14
- Last updated
- 2018-11-27
- Results first posted
- 2015-08-05
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab | Stage I: Cycle (Cy) 7 Day (D) 21 (within 2 hours predose on Cy8) of induction treatment (1 Cy=3 weeks) | |
| Primary | Stage II: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for Non-Hodgkin Lymphoma (NHL) | Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks) | Overall Response comprised complete response (CR), CR unconfirmed (CRu), or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and computed tomography (CT) scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by more than (\>) 75% in the sum of the products of greatest diameters (SPD); PR: Greater than or equal to (≥) 50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI was estimated for one sample binomial using Pearson-Clopper. |
| Secondary | Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL | Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks) | Overall Response comprised CR, CRu, or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in the SPD; PR: ≥50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI was estimated for one sample binomial using Pearson-Clopper. |
| Secondary | Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL | Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks) | Overall Response comprised of CR, CRu, or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumour response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in SPD; PR: ≥50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper. |
| Secondary | Stage I: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL | Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks) | Complete Response was comprised CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper. |
| Secondary | Stage II: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL | Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks) | Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper. |
| Secondary | Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL | Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks) | Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper. |
| Secondary | Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL | Stage I and II: Baseline up to 57 days after last maintenance dose (last maintenance dose: maintenance Cy12/Study Cy20 [30 months]) (up to data cutoff of 31 Oct 2017 [up to 6 years]) (1 Cy=8 weeks) | Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper. |
| Secondary | Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL | Stage I and II: Baseline up to 57 days after last maintenance dose (last maintenance dose: maintenance Cy12/Study Cy20 [30 months]) (up to data cutoff of 31 Oct 2017 [up to 6 years]) (1 Cy=8 weeks) | Overall Response comprised of CR, CRu, or PR . A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper. |
| Secondary | Stage I and II (Pooled): Percentage of Participants With Disease Progression/Relapse or Death | Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description) | Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node \>1 cm in its short axis or in the SPD of more than one node. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 \& 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to median of 27 months; up to data cutoff of 31 Oct 2017 \[up to 6 years\]) |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab | Stage I: Cycle (Cy) 7 Day (D) 21 (within 2 hours predose on Cy8) of induction treatment (1 Cy=3 weeks) | Stage I pharmacokinetic (PK) evaluable population comprised all participants with data for Ctrough available at Cycle 7 and/or observed area under the serum concentration-time curve (AUC) available at Cycle 7. Participants were analyzed as per treatment received. Number of participants analyzed = participants analyzed for this outcome measure. | micrograms per milliliter (mcg/mL) | GEOMETRIC_MEAN |
| PRIMARY | Stage II: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for Non-Hodgkin Lymphoma (NHL) | Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks) | Stage II ITT Population included all participants who were randomized in Stage II irrespective whether they received study drug or not. | percentage of participants | NUMBER |
| SECONDARY | Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL | Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks) | Stage I ITT Population included all participants who were randomized in Stage I irrespective whether they received study drug or not. | percentage of participants | NUMBER |
| SECONDARY | Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL | Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks) | ITT Population. | percentage of participants | NUMBER |
| SECONDARY | Stage I: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL | Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks) | Stage I ITT Population. | percentage of participants | NUMBER |
| SECONDARY | Stage II: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL | Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks) | Stage II ITT Population. | percentage of participants | NUMBER |
| SECONDARY | Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL | Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks) | ITT Population. | percentage of participants | NUMBER |
| SECONDARY | Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL | Stage I and II: Baseline up to 57 days after last maintenance dose (last maintenance dose: maintenance Cy12/Study Cy20 [30 months]) (up to data cutoff of 31 Oct 2017 [up to 6 years]) (1 Cy=8 weeks) | ITT population; only participants who entered the maintenance phase and received at least 1 cycle of rituximab maintenance treatment from Cycle 9 to Cycle 20 were included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL | Stage I and II: Baseline up to 57 days after last maintenance dose (last maintenance dose: maintenance Cy12/Study Cy20 [30 months]) (up to data cutoff of 31 Oct 2017 [up to 6 years]) (1 Cy=8 weeks) | ITT population; only participants who entered the maintenance phase and received at least 1 cycle of rituximab maintenance treatment from Cycle 9 to Cycle 20 were included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Stage I and II (Pooled): Percentage of Participants With Disease Progression/Relapse or Death | Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description) | ITT Population. | percentage of participants | NUMBER |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group158
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab | Stage I: Rituximab IV + Chemotherapy (CHOP/CVP) | 83.1 | Geometric Coefficient of Variation 36.7 | micrograms per milliliter (mcg/mL) | |
| Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab | Stage I: Rituximab SC + Chemotherapy (CHOP/CVP) | 134.6 | Geometric Coefficient of Variation 43.2 | micrograms per milliliter (mcg/mL) | |
| Stage II: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for Non-Hodgkin Lymphoma (NHL) | Stage II: Rituximab IV + Chemotherapy (CHOP/CVP) | 85.1 | 95% Confidence Interval 78.1 to 90.5 | percentage of participants | |
| Stage II: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for Non-Hodgkin Lymphoma (NHL) | Stage II: Rituximab SC + Chemotherapy (CHOP/CVP) | 80.3 | 95% Confidence Interval 72.8 to 86.5 | percentage of participants | |
| Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL | Stage I: Rituximab IV + Chemotherapy (CHOP/CVP) | 82.8 | 95% Confidence Interval 71.3 to 91.1 | percentage of participants | |
| Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL | Stage I: Rituximab SC + Chemotherapy (CHOP/CVP) | 90.5 | 95% Confidence Interval 80.4 to 96.4 | percentage of participants | |
| Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL | Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 84.9 | 95% Confidence Interval 79.2 to 89.5 | percentage of participants | |
| Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL | Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 84.4 | 95% Confidence Interval 78.7 to 89.1 | percentage of participants | |
| Stage I: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL | Stage I: Rituximab IV + Chemotherapy (CHOP/CVP) | 25.0 | 95% Confidence Interval 15.0 to 37.4 | percentage of participants | |
| Stage I: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL | Stage I: Rituximab SC + Chemotherapy (CHOP/CVP) | 42.9 | 95% Confidence Interval 30.5 to 56.0 | percentage of participants |
1 to 10 of 158Source ClinicalTrials.gov
See all 158 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Stage I | STARTED | Stage I: Rituximab IV + Chemotherapy (CHOP/CVP) | 64 | |
| Stage I | STARTED | Stage I: Rituximab SC + Chemotherapy (CHOP/CVP) | 63 | |
| Stage I | STARTED | Stage II: Rituximab IV + Chemotherapy (CHOP/CVP) | 0 | |
| Stage I | STARTED | Stage II: Rituximab SC + Chemotherapy (CHOP/CVP) | 0 | |
| Stage I | COMPLETED | Stage I: Rituximab IV + Chemotherapy (CHOP/CVP) | 46 | |
| Stage I | COMPLETED | Stage I: Rituximab SC + Chemotherapy (CHOP/CVP) | 46 | |
| Stage I | COMPLETED | Stage II: Rituximab IV + Chemotherapy (CHOP/CVP) | 0 | |
| Stage I | COMPLETED | Stage II: Rituximab SC + Chemotherapy (CHOP/CVP) | 0 | |
| Stage I | NOT COMPLETED | Stage I: Rituximab IV + Chemotherapy (CHOP/CVP) | 18 | |
| Stage I | NOT COMPLETED | Stage I: Rituximab SC + Chemotherapy (CHOP/CVP) | 17 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events390
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 47 | 210 | |
| other | Nausea | Gastrointestinal disorders | Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 65 | 197 | |
| other | Constipation | Gastrointestinal disorders | Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 55 | 210 | |
| other | Constipation | Gastrointestinal disorders | Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 50 | 197 | |
| other | Diarrhoea | Gastrointestinal disorders | Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 35 | 210 | |
| other | Diarrhoea | Gastrointestinal disorders | Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 34 | 197 | |
| other | Vomiting | Gastrointestinal disorders | Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 27 | 210 | |
| other | Vomiting | Gastrointestinal disorders | Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 29 | 197 | |
| other | Abdominal pain | Gastrointestinal disorders | Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 25 | 210 | |
| other | Abdominal pain | Gastrointestinal disorders | Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 29 | 197 |
1 to 10 of 390Source ClinicalTrials.gov
See all 390 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | ||
| Total, all-cause mortality | Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | ||
| Total, other adverse events | Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 187 | 210 |
| Total, other adverse events | Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 186 | 197 |
| Total, serious adverse events | Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 76 | 210 |
| Total, serious adverse events | Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 74 | 197 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) vs Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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GET https://conductscience.org/api/trials/v1/NCT01200758/registered?page=2