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

NCT01292603 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2018-12-19

Study results available
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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.

Conditions

  • Lymphocytic Leukemia, Chronic

Interventions

DRUG

Cyclophosphamide

Days 1-3 or Days 1-5 of cycles 1-6

DRUG

Fludarabine

Days 1-3 or Days 1-5 of cycles 1-6

DRUG

rituximab [MabThera]

One cycle of intravenous MabThera, followed by 5 cycles of subcutaneous MabThera

DRUG

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.

DRUG

rituximab [MabThera]

6 cycles of intravenous MabThera

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-18
Primary Completion
2014-05-07
Completion
2017-11-17

Countries

  • Argentina
  • Australia
  • Brazil
  • Canada
  • Chile
  • Croatia
  • Czechia
  • France
  • Germany
  • Greece
  • Italy
  • Mexico
  • New Zealand
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01292603 on ClinicalTrials.gov