International, Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Chronic Lymphocytic Leukemia

Arbeitsgemeinschaft medikamentoese Tumortherapie22 sites in 3 countries256 target enrollmentDecember 2009

ConditionsChronic Lymphocytic Leukemia

InterventionsRituximab

DrugsRituximab

Overview

Phase: Phase 3
Intervention: Rituximab
Conditions: Chronic Lymphocytic Leukemia
Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Enrollment: 256
Locations: 22
Primary Endpoint: progression free survival
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to evaluate the ability of Rituximab maintenance therapy to prolong progression free survival in patients with chronic lymphocytic leukemia, who responded to a Rituximab induction therapy.

Registry

clinicaltrials.gov

Start Date

December 2009

End Date

July 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•ECOG performance status 0-2
•Previous Rituximab containing induction treatment of the CLL in 1st or 2nd line
•Patient must be in complete remission or partial remission after an induction treatment containing rituximab
•ANC (absolute neutrophil count) \> 1,0 x 10e9 /L
•Life expectancy \> 6 months
•Patient´s written informed consent
•Patient using a reliable means of contraception for the duration of the treatment including 2 months thereafter

Exclusion Criteria

•Active uncontrolled bacterial, viral or fungal infection
•Significantly reduced organ functions and bone marrow dysfunction not due to CLL
•creatinine clearance of below 30mL/min
•Patients with a history of other malignancies within 2 years prior to study entry
•Patients with a history of severe cardiac disease
•Other known comorbidity with the potential to dominate survival
•Transformation to aggressive B-cell malignancy
•Hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the applied drugs
•Medical condition requiring prolonged (\> 1 month) use of oral corticosteroids
•Pregnant or breast feeding women

Arms & Interventions

Rituximab

Treatment with Rituximab 375 mg/m² every 3 months for 24 months

Intervention: Rituximab

Outcomes

Primary Outcomes

progression free survival

Time Frame: 48 months

Clinical PFS is defined as the period from randomization until disease progression according to the NCI criteria or death due to the underlying disease.

Secondary Outcomes

MRD (minimal residual disease) progression free survival(48 months)
conversion rate to MRD negative(48 months)
median MRD levels(48 months)
time to next treatment(48 months)
conversation rate to CR(48 months)
Safety of Rituximab maintenance treatment in patients with CLL(48 months)
benefit according to cytogenetic risk group (trisomy 12, del 11q, del 17p and del 13q), IgVH mutation status, ZAP 70 and CD38 expression(48 months)
effect of MRD levels on clinical PFS and OS(48 months)
event free survival(48 months)
overall survival(48 months)