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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)

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ClinicalTrials.gov Identifier: NCT02423837
Recruitment Status : Recruiting
First Posted : April 22, 2015
Last Update Posted : April 22, 2015
Sponsor:
Information provided by (Responsible Party):
Elena N.Parovichnikova, National Research Center for Hematology, Russia

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.

Condition or disease Intervention/treatment Phase
Follicular Lymphoma Drug: Rituximab, bendamustine Phase 3

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2013
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : April 2021





Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. complete or partial response rates [ Time Frame: From date of randomization up to 90 months ]
    According to NCCN recomendations

  2. 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

  3. Dose reduction rate or interval elongation [ Time Frame: From date of randomization up to 90 months ]
  4. Number of patients which underwent full protocol [ Time Frame: From date of randomization up to 90 months ]
  5. lifespan without progression [ Time Frame: From date of randomization up to 90 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02423837


Contacts
Contact: Elena N Parovichnikova, MD, PhD 495-612-4313 ext 007 director@blood.ru
Contact: Sergey K Kravchenko, MD, PhD 4956132446 ext 007 krav-hsc-ramn@mail.ru

Locations
Russian Federation
National Research Center for Hematology Recruiting
Moscow, Russian Federation, 125167
Contact: Sergey Ki Kravchenko, MD, PhD    495-613-2446 ext 007    krav-hsc-ramn@mail.ru   
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         
Sponsors and Collaborators
National Research Center for Hematology, Russia
Investigators
Principal Investigator: Sergey K Kravchenko, MD, PhD National Research Center for Hematology

Responsible Party: Elena N.Parovichnikova, MD, PhD, National Research Center for Hematology, Russia
ClinicalTrials.gov Identifier: NCT02423837     History of Changes
Other Study ID Numbers: FL-RUS-2013
First Posted: April 22, 2015    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015

Keywords provided by Elena N.Parovichnikova, National Research Center for Hematology, Russia:
follicular lymphoma
bendamustine
rituximab

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Bendamustine Hydrochloride
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action