Overview

This trial is active, not recruiting.

Condition lymphocytic leukemia, chronic
Treatments cyclophosphamide, fludarabine, rituximab [mabthera]
Phase phase 1
Sponsor Hoffmann-La Roche
Start date April 2011
End date November 2017
Trial size 240 participants
Trial identifier NCT01292603, 2010-021380-32, BO25341

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 of every cycle. The anticipated time on study drug is 20 weeks.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
cyclophosphamide
Days 1-3 of cycles 1-6
fludarabine
Days 1-3 of cycles 1-6
rituximab [mabthera]
After 4 cycles of intravenous MabThera without experiencing grade 3 or 4 infusion-related reactions. patients will receive 1 additional cycle of intravenous MabThera and 1 cycle of subcutaneous MabThera.
(Experimental)
cyclophosphamide
Days 1-3 of cycles 1-6
fludarabine
Days 1-3 of cycles 1-6
rituximab [mabthera]
6 cycles of intravenous MabThera
(Experimental)
cyclophosphamide
Days 1-3 of cycles 1-6
fludarabine
Days 1-3 of cycles 1-6
rituximab [mabthera]
One cycle of intravenous MabThera, followed by 5 cycles of subcutaneous MabThera

Primary Outcomes

Measure
Part 1: C(trough) levels of subcutaneous MabThera
time frame: 6 weeks
Part 2: Non-inferiority in observed C(trough) levels between subcutaneous and intravenous MabThera
time frame: 20 weeks

Secondary Outcomes

Measure
Part 2: Physician and nurse opinion on the convenience of subcutaneous MabThera
time frame: 20 weeks
Part 1 and 2: Pharmacokinetics (Area under curve for subcutaneous and intravenous MabThera)
time frame: 20 weeks
Part 1 and 2: Immunogenicity of subcutaneous MabThera
time frame: 20 weeks
Part 1 and 2: Change of blood B-cell levels
time frame: 20 weeks
Part 1: Injection-related reactions during the subcutaneous cycle
time frame: Week 6
Part 1: Patients and nurse preference regarding subcutaneous and intravenous administration
time frame: 6 weeks
Part 2: Safety (nature and incidence of adverse events)
time frame: 20 weeks
Part 2: Physician and nurse opinion on time savings with subcutaneous MabThera
time frame: 20 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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 - 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

Additional Information

Official title An Adaptive, Comparative, Randomized, Parallel-group, Multi Center, Phase Ib Study of Subcutaneous (SC) Rituximab Versus Intravenous (IV) Rituximab Both in Combination With Chemotherapy (Fludarabine and Cyclophosphamide), in Patients With Previously Untreated CLL
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.