A Study of Participant Preference With Subcutaneous Versus Intravenous MabThera/Rituxan in Participants With CD20+ Diffuse Large B-Cell Lymphoma or CD20+ Follicular Non-Hodgkin's Lymphoma Grades 1, 2 or 3a

Roche

Status and phase: Completed; Phase 3

Conditions: Diffuse Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma

Treatments: Drug: Rituximab; Drug: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP); Drug: Bendamustine; Drug: Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01724021

2012-003230-17 (EudraCT Number)

MO28457

Details and patient eligibility

About

This multi-center, open-label, randomized study will evaluate the participant preference with subcutaneous versus intravenous administration of MabThera/Rituxan (rituximab) in participants with CD20+ diffuse large B-cell lymphoma or CD20+ follicular non-Hodgkin's lymphoma. In Arm A, participants will receive MabThera/Rituxan 375 mg/m2 intravenously (IV) on Day 1 of Cycle 1 and MabThera/Rituxan 1400 mg subcutaneously (SC) on Day 1 of Cycles 2-4, followed by MabThera/Rituxan IV in Cycles 5-8. Participants in Arm B will receive MabThera/Rituxan IV in Cycles 1-4 and SC in Cycles 5-8. All participants will receive 6-8 cycles of standard chemotherapy (according to local country practice) with 8 cycles of MabThera/Rituxan. Anticipated time on study treatment is up to 24 weeks.

Enrollment: 743 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult participants , >/= 18 and </= 80 years of age
• Histologically confirmed, previously untreated CD20+ diffuse large B-cell lymphoma (DLBCL) or CD20+ follicular non-Hodgkin's lymphoma (NHL) Grade 1, 2, or 3a, according to World Health Organization (WHO) classification
• An International Prognostic Index (IPI) score of 1-4 or IPI score of 0 with bulky disease, defined as one lesion >/= 7.5 cm, or Follicular Lymphoma International Prognostic Index (FLIPI; low, intermediate or high risk)
• At least one bi-dimensionally measurable lesion defined as >/=1.5 cm in its largest dimension on CT scan
• Eastern Cooperative Oncology Group (ECOG) performance status </= 3

Exclusion criteria

• Transformed lymphoma or follicular lymphoma IIIB
• Primary central nervous system (CNS) lymphoma, histologic evidence of transformation to Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, primary cutaneous DLBCL, or primary DLBCL of the testis
• History of other malignancy that could affect compliance with the protocol or interpretation of the results; this includes a malignancy that has been treated but not with curative intent, unless the malignancy has been in remission for >/= 5 years prior to enrolment; participants with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix are eligible
• Prior therapy for DLBCL or NHL, with the exception of nodal biopsy or local irradiation
• Prior treatment with cytotoxic drugs (with the exclusion of intrathecal methotrexate for CNS prophylaxis in DLBCL) or rituximab for another condition, or prior use of an anti-CD20 drug
• Prior use of monoclonal antibody within 3 months prior to randomization
• Chemotherapy or other investigational therapy within 28 days prior to randomization
• Ongoing corticosteroid use > 30 mg/day prednisolone or equivalent
• Inadequate renal. hematologic or hepatic function
• Active and/or severe infection or any major episode of infection within 4 weeks prior to randomization
• Active hepatitis B virus or active hepatitis C virus infection
• History of human immunodeficiency (HIV) seropositive status
• A positive pregnancy test in women of childbearing potential
• Life expectancy of less than 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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743 participants in 2 patient groups

Arm A

Experimental group

Description:

Participants in Arm A received one cycle of rituximab 375 mg/m\^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m\^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.

Treatment:

Drug: Rituximab

Drug: Rituximab

Drug: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)

Drug: Rituximab

Drug: Bendamustine

Drug: Rituximab

Drug: Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)

Arm B

Experimental group

Description:

Participants in Arm B received four cycles of rituximab 375 mg/m\^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.

Treatment:

Drug: Rituximab

Drug: Rituximab

Drug: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)

Drug: Rituximab

Drug: Bendamustine

Drug: Rituximab

Drug: Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)