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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01118234
• Date of registration: 03/05/2010
• Primary sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Public title: Rituximab Versus Observation as Maintenance Therapy in Chronic Lymphocytic Leukemia (Chronic Lymphocytic Leukemia)
• Scientific title: International, Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Chronic Lymphocytic Leukemia
• Date of first enrolment: December 2009
• Target sample size: 256
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01118234
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Austria, Czech Republic, Slovakia

Contacts

• Name: Daniela Wolkersdorfer, Dr.

• Name: Richard Greil, Prof. Dr.
• Affiliation: Arbeitsgemeinschaft medikamentoese Tumortherapie

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Lymphocytic Leukemia

Intervention(s)

Drug: Rituximab

Primary Outcome(s)

progression free survival [Time Frame: 48 months]

Secondary Outcome(s)

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]

conversation rate to CR [Time Frame: 48 months]

conversion rate to MRD negative [Time Frame: 48 months]

effect of MRD levels on clinical PFS and OS [Time Frame: 48 months]

event free survival [Time Frame: 48 months]

median MRD levels [Time Frame: 48 months]

MRD (minimal residual disease) progression free survival [Time Frame: 48 months]

overall survival [Time Frame: 48 months]

Safety of Rituximab maintenance treatment in patients with CLL [Time Frame: 48 months]

time to next treatment [Time Frame: 48 months]

Secondary ID(s)

Mabtenance

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Roche Pharma AG