Clinical trial · Interventional
Bendamustine in Combination With Rituximab as a First-line Therapy Followed by Maintenance Therapy With Rituximab in Patients With Follicular Lymphoma
Prospective Multicenter Study: Bendamustine in Combination With Rituximab as a First-line Therapy Followed by Maintenance Therapy With Rituximab in Patients With Follicular Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
* 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab, bendamustine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Efficacy (tumor size evaluation)
- timeFrame
- From date of randomization until ending of first line R-B therapy (up to 6 months)
- description
- tumor size will be estimated using computed tomography, ultrasonography, fibragastroduodenoscopy and colonoscopy
- measure
- hematologic and nonhematologic toxicity (changes in leukocytes and trombocytes count, hemoglobin concentration, biochemical blood tests, electrocardiography)
- timeFrame
- From date of randomization until ending of first line R-B therapy (up to 6 months)
- description
- clinical blood tests, biochemical blood tests, electrocardiography
Secondary outcomes (5)
- measure
- complete or partial response rates
- timeFrame
- From date of randomization up to 90 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * The presence of a second malignancy within the last 5 years prior to the inclusion into the study except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or prostate cancer. * 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 * Neutrophils count \< 1500/mm3 and/or platelets count \< 75000/mm3. * Surgery prior 15 days before therapy initiation. * In case of serious infectious complications relief, uncontrolled diabetes, hemorrhagic syndrome, hypertension patient may be included into the study
References
Publications (0)
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