Clinical trial · Interventional
MabRella Study: A Study to Evaluate the Safety of Switching From Intravenous to Subcutaneous Administration of Rituximab During First-Line Treatment for Lymphoma
Open Label, Single-arm, Phase IIIb Clinical Trial to Evaluate the Safety of Switching From Intravenous Rituximab to Subcutaneous Rituximab During First Line Treatment for CD20+ Non-Hodgkin's Follicular Lymphoma and Diffuse Large B-cell Lymphoma.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Non Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Subcutaneous Rituximab
- description
- Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab will be treated with subcutaneous (SC) rituximab. Participants with FL will be administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL will be administered 1400 mg SC of rituximab 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.
- interventionNames
- Drug: Rituximab
Primary outcomes (1)
- measure
- Percentage of Participants With Administration-Associated Reactions (AARs)
- timeFrame
- From start of treatment to end of treatment (up to 32 months)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 and ≤ 80 years at time of enrolment. * Life expectancy ≥ 6 months. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3. * Fertile men or women of childbearing potential must use effective contraception until at least 12 months after the last dose; women must not be pregnant. * Histologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL) or CD20+ follicular Non-Hodgkin Lymphoma (FL) grade 1, 2 or 3a according to the World Health Organisation Classification system. Induction only: * Participants with Follicular Lymphoma should meet Groupe D'Etude des Lymphomes Folliculaires (GELF) criteria to initiate treatment. * At least tumor \>/= 1.5 cm as measured by computed tomography (CT) scan. FL treatment-related criteria \- Currently being treated with rituximab IV during first-line therapy and has received at least one full dose of rituximab IV. Exclusion Criteria: * Transformed lymphoma. * Primary central nervous system lymphoma, primary effusion lymphoma, primary mediastinal DLBCL, DLBCL of the testis, primary cutaneous DLBCL or histologic evidence of transformation to a Burkitt lymphoma. * History of other cancer, including one that has been treated but not with curative intent, unless the cancer has been in remission without treatment for \>/= 5 years prior to dosing. Note: Participants with a history of cured skin cancer or in situ carcinoma of the cervix are eligible for the study. * Ongoing corticosteroid use \> 30 mg/day of prednisone or equivalent. Note: Participants receiving corticosteroid treatment with \</= 30 mg/day of prednisone or equivalent must be on a stable regimen for at least 4 weeks prior to start of dosing. * Inadequate renal, hematologic, or hepatic function. * History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products. * For participants with DLBCL: Contraindication to any of the individual components of CHOP (cyclophosphamide, vincristine, doxorubicin and prednisone), including prior anthracycline treatment. * For participants with FL: contraindication to standard chemotherapy. * Other serious underlying medical conditions. * Recent major surgery (within 4 weeks prior to dosing), other than for diagnosis. * Active and/or severe infections (excluding nail fungal infections) or any infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to dosing. * Active Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection. Note: Participants testing positive for Hepatitis B or C virus antibodies but with an undetectable viral load may be included. * History of Human Immunodeficiency Virus (HIV) positive status.
References
Publications (2)
- DERIVEDPetrini M, Gaidano G, Mengarelli A, Consoli U, Santoro A, Liberati AM, Ladetto M, Fraticelli V, Guarini A, Mannina D, Ferrando P, Corradini P, Musto P, Stelitano C, Marino D, Camera A, Murineddu M, Battistini R, Caparrotti G, Turrini M, Arcaini L, Santini S, Cerqueti M, Ferreri AJM, Cantore N, Inzoli A, Cardinale G, Ronci B, La Nasa G, Massimi S, Gaglione G, Barbiero V, Martelli M. Safety and Efficacy of Subcutaneous Rituximab in Previously Untreated Patients with CD20+ Diffuse Large B-Cell Lymphoma or Follicular Lymphoma: Results from an Italian Phase IIIb Study. Adv Hematol. 2022 Jan 27;2022:5581772. doi: 10.1155/2022/5581772. eCollection 2022. PMID 35126524
- DERIVEDGarcia-Munoz R, Quero C, Perez-Persona E, Domingo-Garcia A, Perez-Lopez C, Villaescusa-de-la-Rosa T, Martinez-Castro AM, Arguinano-Perez JM, Parra-Cuadrado JF, Panizo C. Safety of switching from intravenous to subcutaneous rituximab during first-line treatment of patients with non-Hodgkin lymphoma: the Spanish population of the MabRella study. Br J Haematol. 2020 Mar;188(5):661-673. doi: 10.1111/bjh.16227. Epub 2019 Oct 1. PMID 31573078