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A Study of MabThera/Rituxan (Rituximab) in Combination With Fludarabine And Cyclophosphamide as Primary Therapy in Elderly Patients With Chronic Lymphocytic Leukemia

NCT01263704 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2018-04-23

Study results available
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Summary

This single arm, open-label study will assess the safety and efficacy of low dose fludarabine and cyclophosphamide in combination with standard dose MabThera/Rituxan (rituximab) as primary therapy in elderly patients (\>/= 65 years) with chronic lymphocytic leukemia. Patients will receive six 28-day cycles of treatment with Mabthera/Rituxan (375 mg/m2 intravenously \[iv\] Day 0 of cycle 1, 500 mg/m2 iv Day 1 of cycles 2-6), fludarabine (12.5 mg/m2/d iv Days 1-3, cycles 1-6) and cyclophosphamide (150 mg/m2/d iv Days 1-3, cycles 1-6). Anticipated time on study treatment is 6 months, with a 30-month follow-up period.

Conditions

  • Lymphocytic Leukemia, Chronic

Interventions

DRUG

Cyclophosphamide

150 milligrams per square meter (mg/m\^2) intravenously (IV) on Days 1-3 of each 28-day cycle for 6 cycles

DRUG

Fludarabine

12.5 mg/m\^2 IV on Days 1-3 of every 28-day cycle for 6 cycles

DRUG

Rituximab

375 mg/m\^2 IV Day 0 of Cycle 1, 500 mg/m\^2 IV Day 1 of Cycles 2-6. Each cycle was 28 days.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-17
Primary Completion
2017-04-03
Completion
2017-04-03
FDA Drug
Yes

Countries

  • Israel

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 NCT01263704 on ClinicalTrials.gov