Phase II Study of High-Dose Rituximab in High-Risk Chronic Lymphocytic Leukemia Patients in Suboptimal Response After Induction Immunochemotherapy (HYDRIC)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of High-Dose Rituximab in High-Risk Chronic Lymphocytic Leukemia Patients in Suboptimal Response After Induction Immunochemotherapy|
- rate of conversion into Minimal Residual Disease negativity [ Time Frame: Month 7 (= 3 months after the last dose of rituximab) ] [ Designated as safety issue: No ]Evaluate the rate of conversion into MRD negativity 3 months after the administration of 4 monthly courses of high-dose (2000 mg) rituximab in high-risk CLL patients with suboptimal response after immunochemotherapy (ICT), or MRD relapse after ICT.
- toxicity of the consolidation treatment by rituximab [ Time Frame: from first administration of rituximab until end of follow-up period (= 12 months after the last rituximab administration) ] [ Designated as safety issue: Yes ]
- Pharmacokinetic/Pharmacodynamic correlation [ Time Frame: month 7 ] [ Designated as safety issue: No ]correlation between the level of MRD conversion at month 7 and pharmacokinetic dosage of rituximab performed after each rituximab perfusions, 1 month and 3 months after last rituximab.
- quality of life study [ Time Frame: during 17 months ] [ Designated as safety issue: No ]from selection visit until last follow-up visit planned 1 years after the last rituximab perfusion
|Study Start Date:||July 2012|
|Study Completion Date:||May 2015|
|Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
4 monthly administrations of rituximab
2000 mg, IV, monthly, for 4 months (= 4 doses)
Other Name: Mabthera
This study is reserved for patients with residual disease at the end of therapy at the level of Minimal Residual Disease (MRD-positive either in the peripheral blood at least 6 months after the last dose of rituximab-containing immunochemotherapy or in the bone marrow at least 3 months after the last dose of rituximab-containing immunochemotherapy). Patients who have achieved MRD eradication and who have MRD relapse (reappearance of residual leukemic cells using 7/8-color flow cytometry in peripheral blood or bone marrow) are also eligible for the study.
Rituximab will be given intravenously at a monthly dose of 2000 mg four months (in total 4 doses of 2000 mg each), starting within one month after informed consent signature.
The patients will be followed during the treatment period with rituximab. A final evaluation will be done 3 months after the last dose of rituximab.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01625741
|Antwerpen, Belgium, 2020|
|Clinique Sud Luxembourg|
|Arlon, Belgium, 6700|
|Brugge, Belgium, 8000|
|Cliniques universitaires Saint Luc|
|Brussels, Belgium, 1200|
|Clinique Saint Jean|
|Brussels, Belgium, 1000|
|Brussels, Belgium, 1070|
|Grand Hôpital de Charleroi|
|Charleroi, Belgium, 6000|
|Gent, Belgium, 9000|
|Hôpital de Jolimont|
|Haine-Saint-Paul, Belgium, 7100|
|Leuven, Belgium, 3000|
|CHU ULg Sart Tilman|
|Liège, Belgium, 4000|
|CHR Clinique Saint Joseph|
|Mons, Belgium, 7000|
|Clinique Saint Pierre|
|Ottignies, Belgium, 1340|
|Roeselaere, Belgium, 8800|
|Clinique universitaire de Mont Godinne|
|Yvoir, Belgium, 5530|
|Principal Investigator:||Eric Van Den Neste, MD, PhD||Cliniques universitaires Saint-Luc|