Bendamustine in Combination With Rituximab as a First-line Therapy Followed by Maintenance Therapy With Rituximab in Patients With Follicular Lymphoma
BRiF
Prospective Multicenter Study: Bendamustine in Combination With Rituximab as a First-line Therapy Followed by Maintenance Therapy With Rituximab in Patients With Follicular Lymphoma
1 other identifier
interventional
200
1 country
1
Brief Summary
- To evaluate the efficacy of bendamustine in combination with rituximab as first line in patients with follicular lymphoma, 1-3A cytological type.
- To evaluate the safety, tolerability and feasibility of bendamustine in combination with rituximab as 1st line in patients with follicular lymphoma, 1-3A cytological type.
- To evaluate the impact of the regimen modification (bendamustine dose modification and/or extension of inter-cycle interval) into duration of complete and partial responses.
- To evaluate estimated treatment duration, reasons of treatment withdrawal.
- To evaluate the possibility of unification and standardization of therapy protocol BR (rituximab 375 mg/m2 on day 1 and bendamustine 90 mg/m2 on days 1-2).
- To evaluate factors affecting overall and progression-free survival.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2013
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 14, 2014
CompletedFirst Posted
Study publicly available on registry
April 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedApril 22, 2015
April 1, 2015
2.2 years
April 14, 2014
April 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Efficacy (tumor size evaluation)
tumor size will be estimated using computed tomography, ultrasonography, fibragastroduodenoscopy and colonoscopy
From date of randomization until ending of first line R-B therapy (up to 6 months)
hematologic and nonhematologic toxicity (changes in leukocytes and trombocytes count, hemoglobin concentration, biochemical blood tests, electrocardiography)
clinical blood tests, biochemical blood tests, electrocardiography
From date of randomization until ending of first line R-B therapy (up to 6 months)
Secondary Outcomes (5)
complete or partial response rates
From date of randomization up to 90 months
hematologic and nonhematologic toxicity (clinical blood tests, biochemical blood tests, blood pressure measurement, pulse rate, electrocardiography)
From date of randomization up to 90 months
Dose reduction rate or interval elongation
From date of randomization up to 90 months
Number of patients which underwent full protocol
From date of randomization up to 90 months
lifespan without progression
From date of randomization up to 90 months
Interventions
Eligibility Criteria
You may qualify if:
- Patients with the diagnosis of follicular lymphoma confirmed by immunohistochemistry (IHC) analysis in the reference laboratory
- Written informed consent for the use of personal data approved by Independent Ethic Committee
- Men and women patients, 18-75 years old
- ECOG performance status ≤ 3
- No previous treatment with chemotherapy and/or radiation therapy of follicular lymphoma
You may not qualify if:
- The patient is participating in any clinical trials and/or receiving the experimental treatment.
- Transformation of follicular lymphoma to large cell lymphoma (for example, follicular lymphoma IIIB graduation, diffuse large B-cell lymphoma).
- Central nervous system involvement.
- Clinically significant cardiovascular or cerebro-vascular disease in the past 6 months, such as acute myocardial infarction, unstable angina, significant ventricular arrhythmia, severe heart failure (NYNA class IV), stroke, or uncontrolled hypertension.
- Renal impairment (serum creatinine \> 150 umol/L), except lymphoid infiltration of kidneys and tumor lysis syndrome.
- Liver failure (except leukemic/lymphoid organ infiltration), acute hepatitis (serum bilirubin \> 2 x ULN, the activity of ALT and AST \> 4 x ULN, prothrombin index \< than 50%).
- Uncontrolled diabetes mellitus (serum glucose \> 15 mmol/L)
- Sepsis (septicopyemic focuses, hemodynamic instability, inefficiency of antibacterial therapy) or acute infectious diseases.
- HIV, hepatitis B and C (including the absence of the Hbc and Hbs antibodies).
- Life-threatening bleeding, except of bleeding from the gastrointestinal tract caused by neoplastic process.
- Severe mental disorders (schizophrenia, major depressive syndrome and other productive symptoms).
- Physical failure requiring constant care, cachexia (total protein \< 35 g/L).
- Known hypersensitivity to rituximab components.
- Known hypersensitivity to bendamustine components.
- Pregnant or currently breast-feeding woman
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Research Center for Hematology
Moscow, 125167, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sergey K Kravchenko, MD, PhD
National Research Center for Hematology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
April 14, 2014
First Posted
April 22, 2015
Study Start
December 1, 2013
Primary Completion
February 1, 2016
Study Completion
April 1, 2021
Last Updated
April 22, 2015
Record last verified: 2015-04