MabRella Study: A Study to Evaluate the Safety of Switching From Intravenous to Subcutaneous Administration of Rituximab During First-Line Treatment for Lymphoma
CompletedPhase 3Results postedLast updated 26 December 2018
What this trial tests
Phase 3 trial testing Rituximab in Lymphoma, Non Hodgkin in 140 participants. Completed in 11 April 2017.
Adults 18 to 80, any sex, with Lymphoma, Non Hodgkin. 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.
Percentage of Participants With Administration-Associated Reactions (AARs)Primary· From start of treatment to end of treatment (up to 32 months)
AARs were defined as all adverse events (AEs) occurring within 24 hours of rituximab SC administration and which were considered related to study drug. AARs included infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof. Grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
At Least One AAR
Group
Value
95% CI
Diffuse Large B-Cell Lymphoma (DLBCL)
34.5
Follicular Lymphoma (FL)
52.3
Subcutaneous Rituximab
48.6
At Least One AAR Grade ≥ 3
Group
Value
95% CI
Diffuse Large B-Cell Lymphoma (DLBCL)
0
Follicular Lymphoma (FL)
2.7
Subcutaneous Rituximab
2.1
At Least One Serious AARs
Group
Value
95% CI
Diffuse Large B-Cell Lymphoma (DLBCL)
0
Follicular Lymphoma (FL)
1.8
Subcutaneous Rituximab
1.4
Generalised or Remote from the Injection Site AARs
Group
Value
95% CI
Diffuse Large B-Cell Lymphoma (DLBCL)
57.9
Follicular Lymphoma (FL)
11.1
Subcutaneous Rituximab
15.1
Localised at the injection site AARs
Group
Value
95% CI
Diffuse Large B-Cell Lymphoma (DLBCL)
42.1
Follicular Lymphoma (FL)
88.9
Subcutaneous Rituximab
84.9
Percentage of Participants With At Least One Grade >/= 3 Adverse Events (AEs)Secondary· From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events. Grading was completed according to the
Group
Value
95% CI
Diffuse Large B-Cell Lymphoma (DLBCL)
48.3
Follicular Lymphoma (FL)
36.0
Subcutaneous Rituximab
38.6
Percentage of Participants With At Least One Grade >/= 3 Infusion/ Injection Related Reactions (IIRRs)Secondary· From start of treatment to end of treatment (up to 32 months)
Grading of IIRRs was completed according to the CTCAE, version 4.0.
Group
Value
95% CI
Diffuse Large B-Cell Lymphoma (DLBCL)
0.0
Follicular Lymphoma (FL)
2.7
Subcutaneous Rituximab
2.1
Percentage of Participants With At Least One Serious Adverse Event (SAE)Secondary· From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
SAE was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/ birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.
Group
Value
95% CI
Diffuse Large B-Cell Lymphoma (DLBCL)
37.9
Follicular Lymphoma (FL)
27.9
Subcutaneous Rituximab
30.0
Event-Free Survival (EFS)Secondary· From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)
EFS was defined as the time from first dose of rituximab IV to first occurrence of progressive disease (PD) or relapse, according to the International Working Group (IWG) response criteria or initiation of a non-protocol-specified anti-lymphoma therapy or death, whichever occurs first. PD: \>/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities.
Group
Value
95% CI
Diffuse Large B-Cell Lymphoma (DLBCL)
25.79
20.800 – 30.776
Follicular Lymphoma (FL)
54.39
51.416 – 57.362
Subcutaneous Rituximab
52.314
49.162 – 55.466
Progression-Free Survival (PFS)Secondary· From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)
PFS was defined as the time from first dose of rituximab IV to the first occurrence of progressive disease (PD) or relapse, according to the International Working Group (IWG) response criteria or death from any cause. PD: \>/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities.
Group
Value
95% CI
Diffuse Large B-Cell Lymphoma (DLBCL)
27.952
23.443 – 32.460
Follicular Lymphoma (FL)
54.389
51.416 – 57.362
Subcutaneous Rituximab
53.118
50.108 – 56.127
Overall Survival (OS)Secondary· From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)
OS was defined as the time from first dose of rituximab IV to death from any cause.
Group
Value
95% CI
Diffuse Large B-Cell Lymphoma (DLBCL)
37.42
33.354 – 41.485
Follicular Lymphoma (FL)
60.61
59.692 – 61.535
Subcutaneous Rituximab
59.516
57.999 – 61.033
Disease-Free Survival (DFS)Secondary· From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)
DFS was assessed in participants achieving complete response (CR) including complete response unconfirmed (Cru) and was defined as the period from the date of the initial CR/CRu until the date of relapse or death from any cause. CR: 1) disappearance of all evidence/symptoms of disease, 2) lymph nodes and nodal masses normal size, 3) enlarged spleen must have regressed in size, 4) normal bone marrow; CRu: see 1) and 3) of CR plus \> 75% decrease in residual lymph node mass, indeterminate bone marrow. Reported here is the truncated mean estimate based on Kaplan-Meier analysis.
Group
Value
95% CI
Diffuse Large B-Cell Lymphoma (DLBCL)
26.062
23.510 – 28.613
Follicular Lymphoma (FL)
NA
NA – NA
Subcutaneous Rituximab
33.044
31.489 – 34.600
Treatment Response RateSecondary· 4-6 weeks after the last dose of Induction (Up to approximately 8 months)
Treatment response rate was classified according to the International Working Group (IWG) response criteria: CR/Cru, partial response (PR), stable disease (SD) and PD. CR: 1) disappearance of all evidence/symptoms of disease, 2) lymph nodes and nodal masses normal size, 3) enlarged spleen must have regressed in size, 4) normal bone marrow; CRu: see 1) and 3) of CR plus \> 75% decrease in residual lymph node mass, indeterminate bone marrow; PR: \>/= 50% decrease lymph nodes and nodal mass size; decrease in liver/spleen size, no new sites; SD: less than a PR, but is not PD; PD: \>/= 50% increase
Complete Response (CR)
Group
Value
95% CI
Diffuse Large B-Cell Lymphoma (DLBCL)
62.1
Follicular Lymphoma (FL)
66.7
Subcutaneous Rituximab
64.3
Complete Response Unconfirmed (CRU)
Group
Value
95% CI
Diffuse Large B-Cell Lymphoma (DLBCL)
3.4
Follicular Lymphoma (FL)
7.4
Subcutaneous Rituximab
5.4
Partial Response (PR)
Group
Value
95% CI
Diffuse Large B-Cell Lymphoma (DLBCL)
3.4
Follicular Lymphoma (FL)
11.1
Subcutaneous Rituximab
7.1
Stable Disease (SD)
Group
Value
95% CI
Diffuse Large B-Cell Lymphoma (DLBCL)
0.0
Follicular Lymphoma (FL)
3.7
Subcutaneous Rituximab
1.8
Progressive disease (PD)
Group
Value
95% CI
Diffuse Large B-Cell Lymphoma (DLBCL)
17.2
Follicular Lymphoma (FL)
7.4
Subcutaneous Rituximab
12.5
Unable to Assess (UA)
Group
Value
95% CI
Diffuse Large B-Cell Lymphoma (DLBCL)
6.9
Follicular Lymphoma (FL)
0.0
Subcutaneous Rituximab
3.6
Not Evaluable
Group
Value
95% CI
Diffuse Large B-Cell Lymphoma (DLBCL)
6.9
Follicular Lymphoma (FL)
3.7
Subcutaneous Rituximab
5.4
Adverse events — posted to ClinicalTrials.gov
Time frame: From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This open-label, single-arm, phase IIIb study will evaluate the safety of switching from intravenous (IV) to subcutaneous (SC) administration of rituximab during first-line treatment for participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) who have already received at least one full dose of rituximab IV. Participants with FL will be given 1400 mg rituximab SC during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). 1400 mg SC of rituximab will be given to participants with DLBCL once monthly for 4-7 cycles. Treatment duration is expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
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NCT07365306 — Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant
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NCT06965114 — Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia
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NCT07335562 — A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versu
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 26 December 2018
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/NCT01987505.