Phase 3
Completed N=140
MabRella Study: A Study to Evaluate the Safety of Switching From Intravenous to Subcutaneous Administration of Rituximab During First-Line Treatment for Lymphoma
Lymphoma, Non Hodgkin
Source: ClinicalTrials.gov NCT01987505 ↗
Enrolled (actual)
140
Serious AEs
30.0%
Results posted
Jul 2018
Primary outcomePrimary: Percentage of Participants With Administration-Associated Reactions (AARs) — 34.5; 52.3; 48.6; 0 percentage of participants
◆ Published Evidence
Emerging
16citations · ~3 / year
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.
Summary
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.
Linked Publications (2)
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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.
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Administration-Associated Reactions (AARs) |
34.5; 52.3; 48.6; 0; 2.7; 2.1 | — |
| SECONDARY Percentage of Participants With At Least One Grade >/= 3 Adverse Events (AEs) |
48.3; 36.0; 38.6 | — |
| SECONDARY Percentage of Participants With At Least One Grade >/= 3 Infusion/ Injection Related Reactions (IIRRs) |
0.0; 2.7; 2.1 | — |
| SECONDARY Percentage of Participants With At Least One Serious Adverse Event (SAE) |
37.9; 27.9; 30.0 | — |
| SECONDARY Event-Free Survival (EFS) |
25.79; 54.39; 52.314 | — |
| SECONDARY Progression-Free Survival (PFS) |
27.952; 54.389; 53.118 | — |
| SECONDARY Overall Survival (OS) |
37.42; 60.61; 59.516 | — |
| SECONDARY Disease-Free Survival (DFS) |
26.062; NA; 33.044 | — |
| SECONDARY Treatment Response Rate |
62.1; 66.7; 64.3; 3.4; 7.4; 5.4 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01987505) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.