Phase II Study of High-Dose Rituximab in High-Risk Chronic Lymphocytic Leukemia Patients in Suboptimal Response After Induction Immunochemotherapy
NCT01625741 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2015-09-29
Summary
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.
Conditions
Interventions
- DRUG
-
2000 mg, IV, monthly, for 4 months (= 4 doses)
Sponsors & Collaborators
-
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
lead OTHER
Principal Investigators
-
Eric Van Den Neste, MD, PhD · Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-07-31
- Primary Completion
- 2015-05-31
- Completion
- 2015-05-31
Countries
- Belgium
Study Locations
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