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

NCT01446900 | Terminated Phase 2

• 2 other identifiers: IEO S523/1102010-018519-14
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Chronic Lymphocytic Leukaemia; Small Lymphocytic Lymphoma

Keywords

Rituximab; Cladribine; Chronic Lymphocytic Leukaemia; Small Lymphocytic Lymphoma

Outcome Measures

Primary Outcomes (1)

• Response to treatment

  response will be evaluated according to Hallek criteria and definitions

  at month 17

Secondary Outcomes (1)

• Duration of response

  Every 6 months in the first year of follow-up and every 12 months afterwards until disease progression

Study Arms (1)

Rituximab cladribine

EXPERIMENTAL

Drug: Rituximab; Drug: Cladribine

Interventions

Rituximab DRUG

375mg/mq, IV on day 1 of each 28 day cycle for 4 cycles. 375 mg/mq IV every 2 months for a total of 8 administrations as additional infusions for patients, who achieve a partial response or complete response after the therapy with R- 2-CdA.

Also known as: Mabthera

Rituximab cladribine

Cladribine DRUG

0,1 mg/Kg, SC from day 1 to day 5 of each 28 day cycle for 4 cycles.

Also known as: Litak

Rituximab cladribine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Italy

Location

Related Publications (2)

• Bertazzoni 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 BACKGROUND

• Del 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 BACKGROUND

MeSH Terms

Conditions

Leukemia, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Rituximab; Cladribine

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; 2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Giovanni Martinelli, MD

  European Institute of Oncology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2011
• First Posted: October 5, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 31, 2018

Record last verified: 2017-12

Locations

IT (1)