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Rituximab-2cda and Prolongation of Therapy With Rituximab Alone in Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma

Phase 2
18 Years
Open (Enrolling)
Chronic Lymphocytic Leukaemia, Small Lymphocytic Lymphoma

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Trial Information

Rituximab-2cda and Prolongation of Therapy With Rituximab Alone in Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma

Chronic Lymphocytic Leukaemia (CLL) is a lymphoproliferative disorder characterized by the
progressive accumulation of monoclonal peripheral B cells in bone marrow, peripheral blood
and lymphoid tissues. Median survival is about 10 years. It is now clear that front line
therapy for a patient with CLL requiring treatment should be the association of purine
analogue and rituximab with or without cyclophosphamide. Concerning the choice of the purine
analogue, similar results have been obtained by using cladribine instead of fludarabine.
Although cladribine is less commonly used, the direct comparison between the two analogues
for what concerns efficacy and toxicity, has confirmed the same profile of the two drugs.
Encouraging results have been obtained using the monoclonal antibody in association with the
purine analogue.

The utilization of rituximab as a maintenance therapy could improve the response in cases of
persistence of minimal residual disease as well as delay the insurgence of relapses thus
increasing the DFS.

The objective of this study is to confirm the efficacy of the association of R-2cda and of
evaluating the efficacy of prolongation of therapy with additional infusions of Rituximab
alone in increasing and prolonging the duration of the response. The results of this study
will be compared with existing clinical results from a group of 42 pts already treated as
standard with R-2cda without additional rituximab infusions.

Patients enrolled in the study will receive 4 cycles of R-2-CdA therapy. Patients, who
achieve a partial response or complete response after the therapy with R- 2-CdA, will
prolong therapy with Rituximab. The therapy will begin 3 months after the end of the
induction therapy and patients will receive one administration every 2 months for a total of
8 administrations.

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

- 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).

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response to treatment

Outcome Description:

response will be evaluated according to Hallek criteria and definitions

Outcome Time Frame:

at month 17

Safety Issue:


Principal Investigator

Giovanni Martinelli, MD

Investigator Role:

Study Chair

Investigator Affiliation:

European Institute of Oncology


Italy: The Italian Medicines Agency

Study ID:

IEO S523/110



Start Date:

January 2011

Completion Date:

December 2017

Related Keywords:

  • Chronic Lymphocytic Leukaemia
  • Small Lymphocytic Lymphoma
  • Rituximab
  • Cladribine
  • Chronic Lymphocytic Leukaemia
  • Small Lymphocytic Lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma