Bendamustine in Combination With Rituximab as a First-line Therapy Followed by Maintenance Therapy With Rituximab in Patients With Follicular Lymphoma

• Status: Unknown status
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Research Center for Hematology, Russia
• Treatments: Bendamustine Hydrochloride; Rituximab

Criteria

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