An observational study in Chronic Lymphocytic Leukemia, sponsored by Pirogov Russian National Research Medical University. Status unknown at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by Pirogov Russian National Research Medical University · Observational
CLL is an incurable disease with conventional chemotherapy. In the absence of TP53 disruption, a chemoimmunotherapy (CIT) regimen is recommended as front-line and second-line treatment in those patients who attained a long progression-free survival (PFS) with the previous regimen. Bendamustine and rituximab (BR) is one of the most widely adopted CIT regimens, including second-line treatment. Unfortunately, durations of remission following BR combination therapy tend to be short in patients with heavily pre-treated disease or who have already received rituximab. The incorporation of a maintenance following induction chemotherapy to overcome the shorter remission durations in this population is a reasonable option.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 112 is close to the median of 120 across 744 observational studies indexed under Leukemia.
Browse Leukemia studies →Pirogov Russian National Research Medical University is the lead sponsor of 54 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with relapsed or refractory CLL receiving treatment at the University Hematology Hospital and Ambulant clinic.
For inclusion in the research part of maintenance therapy (phase B):
Exclusion Criteria:
Induction plus BR as maintenance (N=56)
Drug: BR as Maintenance
Induction only (N=56)
Patients of the study group who have achieved at least a partial response after 6 cycles of BR induction will receive additionally 4 cycles of BR every 3 months as maintenance therapy.
Progression-free survival
PFS is defined as the number of days from the date of first dose of any study drug (rituximab or bendamustine) to the date of disease progression or death, whichever occurs first. PFS will be compared with its proper historical control (BR as induction without subsequent maintenance).
Time frame: 42 months
Overall Response Rate (ORR)
ORR is defined as the proportion of participants with an overall response (CR, CRi, nodular partial remission \[nPR\] plus partial remission \[PR\]) per the 2008 Modified IWCLL NCI-WG criteria.
Time frame: Approximately 24 months after initial dose of study drug.
Overall Survival (OS)
OS is defined as number of days from the date of first dose of any study drug (rituximab or bendamustine) to the date of death.
Time frame: 60 months (6 months induction therapy, 12 months maintenance, 42 months long-term follow-up
Safety evaluations
To determine the safety and tolerability of induction chemotherapy and maintenance therapy separately for two groups as assessed by CTCAE v4.0:
Time frame: Up to 30 months
Health Related Quality of Life (HRQoL)
To determinate the effect of maintenance therapy on HRQoL using the EORTC Core quality of life questionnaire (QOL-C30, version 3.0).
Time frame: Up to 30 months
This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Pirogov Russian National Research Medical University