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

Primary Purpose

Follicular Lymphoma

Status

Unknown status

Phase

Phase 3

Locations

Russian Federation

Study Type

Interventional

Intervention

Rituximab, bendamustine

About this trial

This is an interventional treatment trial for Follicular Lymphoma focused on measuring follicular lymphoma, bendamustine, rituximab

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

National Research Center for HematologyRecruiting

Outcomes

Primary Outcome Measures

Efficacy (tumor size evaluation)

tumor size will be estimated using computed tomography, ultrasonography, fibragastroduodenoscopy and colonoscopy

hematologic and nonhematologic toxicity (changes in leukocytes and trombocytes count, hemoglobin concentration, biochemical blood tests, electrocardiography)

clinical blood tests, biochemical blood tests, electrocardiography

Secondary Outcome Measures

complete or partial response rates

According to NCCN recomendations

hematologic and nonhematologic toxicity (clinical blood tests, biochemical blood tests, blood pressure measurement, pulse rate, electrocardiography)

clinical blood tests, biochemical blood tests, blood pressure measurement, pulse rate, electrocardiography

Dose reduction rate or interval elongation

Number of patients which underwent full protocol

lifespan without progression

Full Information

NCT ID

NCT02423837

First Posted

April 14, 2014

Last Updated

April 19, 2015

Sponsor

National Research Center for Hematology, Russia

1. Study Identification

Unique Protocol Identification Number

NCT02423837

Brief Title

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

Acronym

BRiF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Unknown status

Study Start Date

December 2013 (undefined)

Primary Completion Date

February 2016 (Anticipated)

Study Completion Date

April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Research Center for Hematology, Russia

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Follicular Lymphoma

Keywords

follicular lymphoma, bendamustine, rituximab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Rituximab, bendamustine

Primary Outcome Measure Information:

Title

Efficacy (tumor size evaluation)

Description

tumor size will be estimated using computed tomography, ultrasonography, fibragastroduodenoscopy and colonoscopy

Time Frame

From date of randomization until ending of first line R-B therapy (up to 6 months)

Title

hematologic and nonhematologic toxicity (changes in leukocytes and trombocytes count, hemoglobin concentration, biochemical blood tests, electrocardiography)

Description

clinical blood tests, biochemical blood tests, electrocardiography

Time Frame

From date of randomization until ending of first line R-B therapy (up to 6 months)

Secondary Outcome Measure Information:

Title

complete or partial response rates

Description

According to NCCN recomendations

Time Frame

From date of randomization up to 90 months

Title

hematologic and nonhematologic toxicity (clinical blood tests, biochemical blood tests, blood pressure measurement, pulse rate, electrocardiography)

Description

clinical blood tests, biochemical blood tests, blood pressure measurement, pulse rate, electrocardiography

Time Frame

From date of randomization up to 90 months

Title

Dose reduction rate or interval elongation

Time Frame

From date of randomization up to 90 months

Title

Number of patients which underwent full protocol

Time Frame

From date of randomization up to 90 months

Title

lifespan without progression

Time Frame

From date of randomization up to 90 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Elena N Parovichnikova, MD, PhD

Phone

495-612-4313

Ext

007

director@blood.ru

First Name & Middle Initial & Last Name or Official Title & Degree

Sergey K Kravchenko, MD, PhD

Phone

4956132446

Ext

007

krav-hsc-ramn@mail.ru

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sergey K Kravchenko, MD, PhD

Organizational Affiliation

National Research Center for Hematology

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Research Center for Hematology

City

Moscow

ZIP/Postal Code

125167

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sergey Ki Kravchenko, MD, PhD

Phone

495-613-2446

Ext

007

krav-hsc-ramn@mail.ru

First Name & Middle Initial & Last Name & Degree

Sergey K Kravchenko, MD, PhD

First Name & Middle Initial & Last Name & Degree

Vladimir I Voroviev, MD, PhD

First Name & Middle Initial & Last Name & Degree

Elena N Baryakh, MD, PhD

First Name & Middle Initial & Last Name & Degree

Ekaterina S Nesterova, MD, PhD

First Name & Middle Initial & Last Name & Degree

Anna E Lukina

12. IPD Sharing Statement

Learn more about this trial

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

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