Phase II Study of High-Dose Rituximab in High-Risk Chronic Lymphocytic Leukemia Patients in Suboptimal Response After Induction Immunochemotherapy

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study ID
NCT01625741
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    2000 mg, IV, monthly, for 4 months (= 4 doses)

Study Details

This study explores the potential to improve the quality of response obtained after induction treatment in Chronic Lymphocytic Leukemia (CLL), by giving a short and intense consolidation schema using high-dose rituximab. Patients in suboptimal response (Minimal Residual Disease persistence) after induction will be selected, as well as those who have a Minimal Residual Disease (MRD) relapse after having achieved MRD negativity.

Key Dates

Start date
Jul 31, 2012
Status verified
Sep 2015
Primary completion
May 31, 2015
Completion
May 31, 2015

Study Design

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

Arms

  • Experimental: rituximab
    4 monthly administrations of rituximab

Primary Outcome Measure

rate of conversion into Minimal Residual Disease negativity [ Time Frame: Month 7 (= 3 months after the last dose of rituximab) ]

Related Studies