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

Sponsor
European Institute of Oncology
Study ID
NCT01446900
Phase
PHASE2
Status
Terminated

Conditions

  • Chronic Lymphocytic Leukaemia
  • Small Lymphocytic Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Jan 31, 2011
Status verified
Dec 2017
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab cladribine

Primary Outcome Measure

Response to treatment [ Time Frame: at month 17 ]

Related Studies