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

January 6, 2020 updated by: Arbeitsgemeinschaft medikamentoese Tumortherapie

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

256

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, 5020
        • Universitätsklinik der PMU Salzburg, Univ-Klinik für Innere Medizin
      • Wien, Austria, 1090
        • AKH Wien, Klinische Abteilung für Hämatologie und Hämostaseologie
      • Wien, Austria, 1140
        • Hanusch Krankenhaus, 3. Med. Abtlg.
    • Niederösterreich
      • Krems, Niederösterreich, Austria, 3500
        • Landesklinikum Krems, Hämato-onkologisches Service
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4021
        • AKH Linz, Department für Innere Medizin 3
      • Steyr, Oberösterreich, Austria, 4400
        • Landeskrankenhaus Steyr, Innere Medizin, Hämatologie, Onkologie
      • Wels, Oberösterreich, Austria, 4600
        • Klinikum Wels-Grieskirchen GmbH, Abteilung für Innere Medizin IV
    • Tirol
      • Hall In Tirol, Tirol, Austria, 6060
        • A.ö. Bezirkskrankenhaus Hall in Tirol, Innere Medizin / Hämato - Onkologie
      • Innsbruck, Tirol, Austria, 6020
        • Universitätsklinik Innsbruck, Innere MEdizin IV / Hämato-Onkologie
      • Kufstein, Tirol, Austria, 6330
        • A.ö. Bezirkskrankenhaus Kufstein, Innere Medizin / Hämatologie / Onkologie
    • Vorarlberg
      • Feldkirch, Vorarlberg, Austria, 6807
        • LKH Feldkirch, Interne E
  • Czechia
      • Brno, Czechia, 62588
        • FN Brno
      • Hradec Kralove, Czechia, 500 05
        • FN Hradec Kralove
      • Olomouc, Czechia
        • FN Olomouc
      • Praha, Czechia, 10034
        • FN Kralovske Vinohrady
      • Praha, Czechia, 12808
        • VFN Praha 2
  • Slovakia
      • Banská Bystrica, Slovakia, 97517
        • F.D. Rossevelt hospital
      • Bratislava, Slovakia, 83310
        • Narodny onkologicky ustav
      • Bratislava, Slovakia, 85107
        • FNsP sv. Cyrila a Metoda
      • Kosice, Slovakia, 04190
        • FNsP L.Pasteura
      • Martin, Slovakia, 03659
        • Martinska Fakultna Nemocnica
      • Presov, Slovakia, 08181
        • FNsP J.A. Reimana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Rituximab
Treatment with Rituximab 375 mg/m² every 3 months for 24 months
Drug: Rituximab
Rituximab (MabThera, F. Hoffmann-La Roche Ltd., Basel, Switzerland) 375 mg/m² every 3 months for 24 months (8 infusions) or observation
NO_INTERVENTION: Observation
Observation for 24 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 48 months
48 months
MRD (minimal residual disease) progression free survival
Time Frame: 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.
48 months
conversion rate to MRD negative
Time Frame: 48 months
48 months
median MRD levels
Time Frame: 48 months
48 months
conversation rate to CR
Time Frame: 48 months
48 months
effect of MRD levels on clinical PFS and OS
Time Frame: 48 months
48 months
event free survival
Time Frame: 48 months
48 months
time to next treatment
Time Frame: 48 months
48 months
Safety of Rituximab maintenance treatment in patients with CLL
Time Frame: 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
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
Time Frame: 48 months
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Collaborators

Roche Pharma AG

Investigators

  • Principal Investigator: Richard Greil, Prof. Dr., Arbeitsgemeinschaft medikamentoese Tumortherapie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2009

Primary Completion (ACTUAL)

February 1, 2018

Study Completion (ACTUAL)

July 1, 2019

Study Registration Dates

First Submitted

May 3, 2010

First Submitted That Met QC Criteria

May 5, 2010

First Posted (ESTIMATE)

May 6, 2010

Study Record Updates

Last Update Posted (ACTUAL)

January 9, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mabtenance

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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