Clinical trial · Interventional
Rituximab Versus Observation as Maintenance Therapy in Chronic Lymphocytic Leukemia (Chronic Lymphocytic Leukemia)
International, Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Chronic Lymphocytic Leukemia
NCT01118234CI-TRIAL-00042665completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Rituximab
- description
- Treatment with Rituximab 375 mg/m² every 3 months for 24 months
- interventionNames
- Drug: Rituximab
- type
- NO_INTERVENTION
- label
- Observation
- description
- Observation for 24 months
Primary outcomes (1)
- measure
- progression free survival
- timeFrame
- 48 months
- description
- 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 outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGreil R, Obrtlikova P, Smolej L, Kozak T, Steurer M, Andel J, Burgstaller S, Mikuskova E, Gercheva L, Nosslinger T, Papajik T, Ladicka M, Girschikofsky M, Hrubisko M, Jager U, Fridrik M, Pecherstorfer M, Kralikova E, Burcoveanu C, Spasov E, Petzer A, Mihaylov G, Raynov J, Oexle H, Zabernigg A, Flochova E, Palasthy S, Stehlikova O, Doubek M, Altenhofer P, Pleyer L, Melchardt T, Klingler A, Mayer J, Egle A. Rituximab maintenance versus observation alone in patients with chronic lymphocytic leukaemia who respond to first-line or second-line rituximab-containing chemoimmunotherapy: final results of the AGMT CLL-8a Mabtenance randomised trial. Lancet Haematol. 2016 Jul;3(7):e317-29. doi: 10.1016/S2352-3026(16)30045-X. Epub 2016 Jun 16. PMID 27374465