Clinical trial · Interventional
R-2cda and Prolongation of Therapy With Rituximab Alone in Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma
Rituximab-2cda and Prolongation of Therapy With Rituximab Alone in Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma
NCT01446900CI-TRIAL-00031473terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low rate in patient accrual
Summary
Brief summary (as posted)
The objective of this study is to confirm the efficacy of the association of R-2cda in patients affected by Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma and of evaluating the efficacy of prolongation of therapy with additional infusions of Rituximab alone in increasing and prolonging the duration of the response.
Conditions
Conditions (2)
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 Leukaemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cladribine | Drug | Cladribine | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituximab cladribine
- interventionNames
- Drug: Rituximab
- Drug: Cladribine
Primary outcomes (1)
- measure
- Response to treatment
- timeFrame
- at month 17
- description
- response will be evaluated according to Hallek criteria and definitions
Secondary outcomes (1)
- measure
- Duration of response
- timeFrame
- Every 6 months in the first year of follow-up and every 12 months afterwards until disease progression
- description
- Duration of response Every 6 months in the first year of follow-up and every 12 months since second year until PD
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged ≥ 18 years * Patients affected by CLL / SLL * Presence of active disease defined as the presence of one of the following: Disease related symptoms (weight loss \>10% in the last 6 months, fever \>38° C for 2 weeks without evidence of infection, or marked asthenia, or profuse sweating without evidence of infection) Massive nodes (at least 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy Massive (at least 6 cm below left costal margin) or progressive or symptomatic splenomegaly Progressive lymphocytosis (increased \>50% in 2 months) or lymphocyte doubling time \< 6 months Evidence of progressive bone marrow insufficiency seen as evidence of or worsening of anemia and or thrombocytopenia Autoimmune anemia and or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy Exclusion Criteria: * Age \< 18 years * Patients with cardiac, pulmonary, neurological, psychiatric or serious metabolic conditions not related to CLL / SLL * Altered hepatic function (bilirubin, GOT, GPT, or gammaGT \> 2 times upper limit of normal) not attributable to CLL / SLL * Altered renal function (creatinine \> 1,5 times upper limit of normal) * Patients with serious active infections * Pregnancy and/ or breastfeeding * Patients with positive serology for HBSAG or HBCAB without evaluation by a hepatologist * Patients with positive serology for HIV * Life expectancy of less than 12 months * Not taking any other experimental drugs * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cladribine (2CdA).
References
Publications (2)
- BACKGROUNDBertazzoni P, Rabascio C, Gigli F, Calabrese L, Radice D, Calleri A, Gregato G, Negri M, Liptrott SJ, Bassi S, Nassi L, Sammassimo S, Laszlo D, Preda L, Pruneri G, Orlando L, Martinelli G. Rituximab and subcutaneous cladribine in chronic lymphocytic leukemia for newly diagnosed and relapsed patients. Leuk Lymphoma. 2010 Aug;51(8):1485-93. doi: 10.3109/10428194.2010.495799. PMID 20578816
- BACKGROUNDDel Poeta G, Del Principe MI, Buccisano F, Maurillo L, Capelli G, Luciano F, Perrotti AP, Degan M, Venditti A, de Fabritiis P, Gattei V, Amadori S. Consolidation and maintenance immunotherapy with rituximab improve clinical outcome in patients with B-cell chronic lymphocytic leukemia. Cancer. 2008 Jan 1;112(1):119-28. doi: 10.1002/cncr.23144. PMID 17999417