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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01118234
Recruitment Status : Active, not recruiting
First Posted : May 6, 2010
Last Update Posted : November 27, 2017
Roche Pharma AG
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Rituximab Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: International, Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Chronic Lymphocytic Leukemia
Study Start Date : December 2009
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. conversion rate to MRD negative [ Time Frame: 48 months ]
  3. median MRD levels [ Time Frame: 48 months ]
  4. conversation rate to CR [ Time Frame: 48 months ]
  5. effect of MRD levels on clinical PFS and OS [ Time Frame: 48 months ]
  6. event free survival [ Time Frame: 48 months ]
  7. time to next treatment [ Time Frame: 48 months ]
  8. overall survival [ Time Frame: 48 months ]
  9. 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

  10. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01118234

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Arbeitsgemeinschaft medikamentoese Tumortherapie Identifier: NCT01118234     History of Changes
Other Study ID Numbers: Mabtenance
First Posted: May 6, 2010    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents