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

• Status: Completed
• Trial end date: 2017-11-17
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Rituximab

Criteria

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