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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01118234
• Other study ID #: Mabtenance
• Status: Completed
• Phase: Phase 3
• Start date: December 2009
• Est. completion date: July 2019

Study information

• Verified date: January 2020
• Source: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: July 2019
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Rituximab
Rituximab (MabThera, F. Hoffmann-La Roche Ltd., Basel, Switzerland) 375 mg/m² every 3 months for 24 months (8 infusions) or observation

Locations

Country	Name	City	State
Austria	LKH Feldkirch, Interne E	Feldkirch	Vorarlberg
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	Landesklinikum Krems, Hämato-onkologisches Service	Krems	Niederösterreich
Austria	A.ö. Bezirkskrankenhaus Kufstein, Innere Medizin / Hämatologie / Onkologie	Kufstein	Tirol
Austria	AKH Linz, Department für Innere Medizin 3	Linz	Oberösterreich
Austria	Universitätsklinik der PMU Salzburg, Univ-Klinik für Innere Medizin	Salzburg
Austria	Landeskrankenhaus Steyr, Innere Medizin, Hämatologie, Onkologie	Steyr	Oberösterreich
Austria	Klinikum Wels-Grieskirchen GmbH, Abteilung für Innere Medizin IV	Wels	Oberösterreich
Austria	AKH Wien, Klinische Abteilung für Hämatologie und Hämostaseologie	Wien
Austria	Hanusch Krankenhaus, 3. Med. Abtlg.	Wien
Czechia	FN Brno	Brno
Czechia	FN Hradec Kralove	Hradec Kralove
Czechia	FN Olomouc	Olomouc
Czechia	FN Kralovske Vinohrady	Praha
Czechia	VFN Praha 2	Praha
Slovakia	F.D. Rossevelt hospital	Banská Bystrica
Slovakia	FNsP sv. Cyrila a Metoda	Bratislava
Slovakia	Narodny onkologicky ustav	Bratislava
Slovakia	FNsP L.Pasteura	Kosice
Slovakia	Martinska fakultna nemocnica	Martin
Slovakia	FNsP J.A. Reimana	Presov

Sponsors (2)

Lead Sponsor	Collaborator
Arbeitsgemeinschaft medikamentoese Tumortherapie	Roche Pharma AG

Countries where clinical trial is conducted

Austria,  Czechia,  Slovakia, 

Outcome

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