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

April 19, 2015 updated by: Elena N.Parovichnikova, National Research Center for Hematology, Russia

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

  • 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Protocol involves 6 courses of rituximab and bendamustine with 26 days interval between each course (one cycle continues 28 days). Control examination will be performed every two courses (28, 56, 84 days of treatment) and will include (physical examination, monitoring of clinical blood tests, biochemical blood tests, computed tomography, ultrasonography, in patients with gastrointestinal tract involvement - fibrogastroduodenoscopy and colonoscopy). Efficacy of therapeutic impact will be estimated as rates of complete remission, partial remission, stable disease or progression based on tumor size reduction comparing with pretreatment data and evaluated using computed tomography and expressed as a percentage. Patients with partial or complete remission or stable disease after 2 courses continue treatment. Patients with tumor progression excluded from issue. Patients which achieved a complete remission after 2 courses may end treatment after 4 courses.

Safety, tolerability and feasibility which implies hematologic and non-hematologic toxicity will be estimated using data of physical examination, monitoring of clinical blood tests, biochemical blood tests and bone marrow analyses (cytological, morphological and genetic tests).

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 125167
        • Recruiting
        • National Research Center for Hematology
        • Contact:
        • Principal Investigator:
          • Sergey K Kravchenko, MD, PhD
        • Sub-Investigator:
          • Vladimir I Voroviev, MD, PhD
        • Sub-Investigator:
          • Elena N Baryakh, MD, PhD
        • Sub-Investigator:
          • Ekaterina S Nesterova, MD, PhD
        • Sub-Investigator:
          • Anna E Lukina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy (tumor size evaluation)
Time Frame: From date of randomization until ending of first line R-B therapy (up to 6 months)
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)
Time Frame: From date of randomization until ending of first line R-B therapy (up to 6 months)
clinical blood tests, biochemical blood tests, electrocardiography
From date of randomization until ending of first line R-B therapy (up to 6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete or partial response rates
Time Frame: From date of randomization up to 90 months
According to NCCN recomendations
From date of randomization up to 90 months
hematologic and nonhematologic toxicity (clinical blood tests, biochemical blood tests, blood pressure measurement, pulse rate, electrocardiography)
Time Frame: From date of randomization up to 90 months
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
Time Frame: From date of randomization up to 90 months
From date of randomization up to 90 months
Number of patients which underwent full protocol
Time Frame: From date of randomization up to 90 months
From date of randomization up to 90 months
lifespan without progression
Time Frame: From date of randomization up to 90 months
From date of randomization up to 90 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Research Center for Hematology, Russia

Investigators

  • Principal Investigator: Sergey K Kravchenko, MD, PhD, National Research Center for Hematology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

April 14, 2014

First Submitted That Met QC Criteria

April 19, 2015

First Posted (Estimate)

April 22, 2015

Study Record Updates

Last Update Posted (Estimate)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 19, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FL-RUS-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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