A Study to Compare Subcutaneous Versus Intravenous MabThera (Rituximab) in Combination With Chemotherapy in Patients With Chronic Lymphocytic Leukemia

Roche

Status and phase: Completed; Phase 1

Conditions: Lymphocytic Leukemia, Chronic

Treatments: Drug: rituximab [MabThera]; Drug: Cyclophosphamide; Drug: Fludarabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01292603

2010-021380-32 (EudraCT Number)

BO25341

Details and patient eligibility

About

This randomized, parallel-group, multi-center study will compare the pharmacokinetics and safety of subcutaneous administration of MabThera (rituximab) versus intravenous MabThera in combination with chemotherapy in previously untreated patients with chronic lymphocytic leukemia (CLL). The study consists of 2 parts. In part 1, patients who have previously received 4 cycles of intravenous MabThera will receive in Cycle 5 intravenous MabThera and in Cycle 6 subcutaneous MabThera. In part 2, patients will be randomized to receive either 6 cycles of intravenous MabThera, or 1 cycle of intravenous MabThera and 5 cycles of subcutaneous MabThera. Additionally, all patients will receive chemotherapy (fludarabine and cyclophosphamide) on Days 1-3 or Days 1-5 of every cycle. The anticipated time on study drug is 24 weeks.

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >/=18 years of age
• Patients with treatment-requiring chronic lymphocytic leukemia (CLL)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Life expectancy >6 months

Exclusion criteria

• Transformation to aggressive B-cell malignancy
• History of other malignancy unless the patient was treated with curative intent and has been in remission for more than 5 years prior to enrolment
• HIV or Hepatitis B positive unless clearly due to vaccination
• Inadequate liver or renal function
• Any coexisting medical or psychological condition that would preclude participation in the required study procedures

Additional exclusion criterion for Part 1:

• Any previous treatment for CLL except for up to 4 cycles of rituximab IV in combination with FC chemotherapy as first-line treatment for CLL

Additional exclusion criterion for Part 2:

• Any previous treatment for CLL

Trial design

240 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: rituximab [MabThera]

Drug: rituximab [MabThera]

Drug: Fludarabine

Drug: rituximab [MabThera]

Drug: Cyclophosphamide

2

Experimental group

Treatment:

Drug: rituximab [MabThera]

Drug: rituximab [MabThera]

Drug: Fludarabine

Drug: rituximab [MabThera]

Drug: Cyclophosphamide

3

Experimental group

Treatment:

Drug: rituximab [MabThera]

Drug: rituximab [MabThera]

Drug: Fludarabine

Drug: rituximab [MabThera]

Drug: Cyclophosphamide