Rituximab Versus Observation as Maintenance Therapy in Chronic Lymphocytic Leukemia (Chronic Lymphocytic Leukemia)
This study is currently recruiting participants.
Verified October 2011 by Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborator:
Roche Pharma AG
Information provided by:
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT01118234
First received: May 3, 2010
Last updated: October 24, 2011
Last verified: October 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2015 |
| Estimated Primary Completion Date: | December 2015 (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
|
Drug: Rituximab
Rituximab (MabThera, F. Hoffmann-La Roche Ltd., Basel, Switzerland) 375 mg/m² every 3 months for 24 months (8 infusions) or observation
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118234
Contacts
| Contact: Daniela Wolkersdorfer, Dr. | +43 664 1422504 | d.wolkersdorfer@agmt.at |
Locations
| Austria | |
| Landesklinikum Krems, Hämato-onkologisches Service | Recruiting |
| Krems, Niederösterreich, Austria, 3500 | |
| Contact: Martin Pecherstorfer, Prof. Dr. Martin.Pecherstorfer@krems.lknoe.at | |
| Principal Investigator: Martin Pecherstorfer, Prof. Dr. | |
| AKH Linz, Department für Innere Medizin 3 | Recruiting |
| Linz, Oberösterreich, Austria, 4021 | |
| Contact: Michael Fridrik, Prim. Doz. Dr. michael.fridrik@akh.linz.at | |
| Principal Investigator: Michael Fridrik, Prim. Dr. | |
| Landeskrankenhaus Steyr, Innere Medizin, Hämatologie, Onkologie | Recruiting |
| Steyr, Oberösterreich, Austria, 4400 | |
| Contact: Johannes Andel, OA Dr. johannes.andel@gespag.at | |
| Principal Investigator: Johannes Andel, OA Dr. | |
| Klinikum Wels-Grieskirchen GmbH, Abteilung für Innere Medizin IV | Recruiting |
| Wels, Oberösterreich, Austria, 4600 | |
| Contact: Josef Thaler, Prof. Dr. josef.thaler@klinikum-wels.at | |
| Principal Investigator: Josef Thaler, Prof. Dr. | |
| A.ö. Bezirkskrankenhaus Hall in Tirol, Innere Medizin / Hämato - Onkologie | Recruiting |
| Hall, Tirol, Austria, 6060 | |
| Contact: Horst Oexle, Dr. | |
| Principal Investigator: Host Oexle, Dr. | |
| Universitätsklinik Innsbruck, Innere MEdizin IV / Hämato-Onkologie | Recruiting |
| Innsbruck, Tirol, Austria, 6020 | |
| Contact: Michael Steurer, Prof. Dr. michael.steurer@i-med.ac.at | |
| Principal Investigator: Michael Steurer, Prof. Dr. | |
| A.ö. Bezirkskrankenhaus Kufstein, Innere Medizin / Hämatologie / Onkologie | Recruiting |
| Kufstein, Tirol, Austria, 6330 | |
| Contact: August Zabernigg, OA Dr. august.zabernigg@bkh-kufstein.at | |
| Principal Investigator: August Zabernigg, OA Dr. | |
| LKH Feldkirch, Interne E | Recruiting |
| Feldkirch, Vorarlberg, Austria, 6807 | |
| Contact: Alois Lang, Dr. alois.lang@lkhf.at | |
| Principal Investigator: Alois Lang, OA Dr. | |
| Universitätsklinik der PMU Salzburg, Univ-Klinik für Innere Medizin | Recruiting |
| Salzburg, Austria, 5020 | |
| Contact: Richard Greil, Prof. Dr. r.greil@salk.at | |
| Principal Investigator: Richard Greil, Prof. Dr. | |
| AKH Wien, Klinische Abteilung für Hämatologie und Hämostaseologie | Recruiting |
| Wien, Austria, 1090 | |
| Contact: Ulrich Jäger, Prof. Dr. | |
| Principal Investigator: Ulrich Jäger, Prof. Dr. | |
| Hanusch Krankenhaus, 3. Med. Abtlg. | Recruiting |
| Wien, Austria, 1140 | |
| Contact: Georg Hopfinger, OA Dr. | |
| Principal Investigator: Georg Hopfinger, OA Dr. | |
| Czech Republic | |
| FN Brno | Recruiting |
| Brno, Czech Republic, 62588 | |
| Contact: Jiri Mayer, Prof. jmayer@fnbrno.cz | |
| Principal Investigator: Jiri Mayer, Prof. | |
| FN Hradec Kralove | Recruiting |
| Hradec Kralove, Czech Republic, 500 05 | |
| Contact: Lukas Smolej, M.D. | |
| Principal Investigator: Lukas Smolej, M.D. | |
| FN Olomouc | Recruiting |
| Olomouc, Czech Republic | |
| Contact: Tomas Papajik, M.D. | |
| Principal Investigator: Tomas Papajik, M.D. | |
| FN Kralovske Vinohrady | Recruiting |
| Praha, Czech Republic, 10034 | |
| Contact: Tomas Kozak, M.D. | |
| Principal Investigator: Tomas Kozak, M.D. | |
| VFN Praha 2 | Recruiting |
| Praha, Czech Republic, 12808 | |
| Contact: Petra Obrtlikova | |
| Principal Investigator: Petra Obrtlikova, M.D. | |
| Slovakia | |
| F.D. Rossevelt hospital | Recruiting |
| Bansky Bystrica, Slovakia, 97517 | |
| Contact: Eva Kralikova, M.D. | |
| Principal Investigator: Eva Kralikova, M.D. | |
| Narodny onkologicky ustav | Recruiting |
| Bratislava, Slovakia, 83310 | |
| Contact: Miriam Ladicka, M.D. ladicka@nou.sk | |
| Principal Investigator: Miriam Ladicka, M.D. | |
| Narodny onkologicky ustav | Recruiting |
| Bratislava, Slovakia, 83310 | |
| Contact: Eva Mikuskova, M.D. eva.mikuskova@nou.sk | |
| Principal Investigator: Eva Mikuskova, M.D. | |
| FNsP sv. Cyrila a Metoda | Recruiting |
| Bratislava, Slovakia, 85107 | |
| Contact: Mikulas Hrubisko, M.D. hrubisko@npba.sk | |
| Principal Investigator: Mikulas Hrubisko, M.D. | |
| FNsP L.Pasteura | Recruiting |
| Kosice, Slovakia, 04190 | |
| Contact: Adriana Kafkova, M.D. | |
| Principal Investigator: Adriana Kafkova, M.D. | |
| Martinska fakultna nemocnica | Recruiting |
| Martin, Slovakia, 03659 | |
| Contact: Emilia Flochova, M.D. flochova@mfn.sk | |
| Principal Investigator: Emilia Flochova, M.D. | |
| FNsP J.A. Reimana | Recruiting |
| Presov, Slovakia, 08181 | |
| Contact: Stanislav Palasthy, M.D. | |
| Principal Investigator: Stanislav Palashty, M.D. | |
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: | Prof. Dr. Richard Greil, AGMT |
| ClinicalTrials.gov Identifier: | NCT01118234 History of Changes |
| Other Study ID Numbers: | Mabtenance |
| Study First Received: | May 3, 2010 |
| Last Updated: | October 24, 2011 |
| 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 Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013