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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT01118234
First received: May 3, 2010
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Rituximab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

Primary Outcome Measures:
  • progression free survival [ Time Frame: 48 months ] [ Designated as safety issue: No ]
    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:
  • MRD (minimal residual disease) progression free survival [ Time Frame: 48 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 48 months ] [ Designated as safety issue: No ]
  • median MRD levels [ Time Frame: 48 months ] [ Designated as safety issue: No ]
  • conversation rate to CR [ Time Frame: 48 months ] [ Designated as safety issue: No ]
  • effect of MRD levels on clinical PFS and OS [ Time Frame: 48 months ] [ Designated as safety issue: No ]
  • event free survival [ Time Frame: 48 months ] [ Designated as safety issue: No ]
  • time to next treatment [ Time Frame: 48 months ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 48 months ] [ Designated as safety issue: No ]
  • Safety of Rituximab maintenance treatment in patients with CLL [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 256
Study Start Date: December 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118234

Locations
Austria
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, 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
Czech Republic
FN Brno
Brno, Czech Republic, 62588
FN Hradec Kralove
Hradec Kralove, Czech Republic, 500 05
FN Olomouc
Olomouc, Czech Republic
FN Kralovske Vinohrady
Praha, Czech Republic, 10034
VFN Praha 2
Praha, Czech Republic, 12808
Slovakia
F.D. Rossevelt hospital
Bansky Bystrica, Slovakia, 97517
FNsP sv. Cyrila a Metoda
Bratislava, Slovakia, 85107
Narodny onkologicky ustav
Bratislava, Slovakia, 83310
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
Investigators
Principal Investigator: Richard Greil, Prof. Dr. Arbeitsgemeinschaft medikamentoese Tumortherapie
  More Information

No publications provided

Responsible Party: Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier: NCT01118234     History of Changes
Other Study ID Numbers: Mabtenance
Study First Received: May 3, 2010
Last Updated: December 23, 2013
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
CLL
Rituximab
Maintenance

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

ClinicalTrials.gov processed this record on November 20, 2014