Rituximab Versus Observation as Maintenance Therapy in Chronic Lymphocytic Leukemia (Chronic Lymphocytic Leukemia)

Phase 3

Completed

• Conditions: Chronic Lymphocytic Leukemia
• Interventions: Drug: Rituximab

• Registration Number: NCT01118234
• Lead Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-05-03
• Study First Submitted QC: 2010-05-05
• Study First Posted: 2010-05-06
• Primary Completion: 2018-02
• Study Completion: 2019-07
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

• B-CLL
• Age >18
• 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
• Any coexisting medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
progression free survival	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 Outcome Measures

Name	Time	Method
MRD (minimal residual disease) progression free survival	48 months	Minimal residual disease progression-free survival is defined as the period from randomization until increase of MRD levels in peripheral blood above 10-3 or, if above 10-3 before, increase of one common logarithm.
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	All grades of infections and G3/4 other clinical adverse events will be documented using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
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

Trial Locations

Locations (22)

Landesklinikum Krems, Hämato-onkologisches Service; 🇦🇹 Krems, Niederösterreich, Austria

AKH Linz, Department für Innere Medizin 3; 🇦🇹 Linz, Oberösterreich, Austria

Landeskrankenhaus Steyr, Innere Medizin, Hämatologie, Onkologie; 🇦🇹 Steyr, Oberösterreich, Austria

Klinikum Wels-Grieskirchen GmbH, Abteilung für Innere Medizin IV; 🇦🇹 Wels, Oberösterreich, Austria

A.ö. Bezirkskrankenhaus Hall in Tirol, Innere Medizin / Hämato - Onkologie; 🇦🇹 Hall In Tirol, Tirol, Austria

Universitätsklinik Innsbruck, Innere MEdizin IV / Hämato-Onkologie; 🇦🇹 Innsbruck, Tirol, Austria

A.ö. Bezirkskrankenhaus Kufstein, Innere Medizin / Hämatologie / Onkologie; 🇦🇹 Kufstein, Tirol, Austria

LKH Feldkirch, Interne E; 🇦🇹 Feldkirch, Vorarlberg, Austria

Universitätsklinik der PMU Salzburg, Univ-Klinik für Innere Medizin; 🇦🇹 Salzburg, Austria

AKH Wien, Klinische Abteilung für Hämatologie und Hämostaseologie; 🇦🇹 Wien, Austria

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