Ribomustin in the Second Line Therapy of Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma

February 19, 2016 updated by: Astellas Pharma Europe B.V.

Observational Program for Evaluation of Ribomustin and Rituximab Combined Therapy With Following Rituximab Maintenance of Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma

Prospective multicenter observational non-interventional study to assess routine clinical practice of Bendamustine use in the second line therapy of relapsed or refractory indolent B-cell non-Hodgkin's lymphoma

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

97

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
      • Barnaul, Russian Federation
        • City Clinical Hospital #8
      • Chelyabinsk, Russian Federation, 454087
        • Chelyabinsk Regional Oncology Dispensary/15
      • Cherepovets, Russian Federation
        • Vologda Regional Clinical Hospital #2
      • Irkutsk, Russian Federation, 664035
        • Regional Oncology Dispensary/35
      • Irkutsk, Russian Federation, 664079
        • Irkutsk Regional Сlinical Hospital/31
      • Kaluga, Russian Federation, 248007
        • Kaluga Regional Clinical Hospital/02
      • Khanty-Mansiysk, Russian Federation
        • District Cancer Center od Khanty -Mansiysk
      • Krasnoyarsk, Russian Federation, 660003
        • City Сlinical Hospital#7/25
      • Krasnoyarsk, Russian Federation, 660022
        • Regional Сlinical Hospital/12
      • Maykop, Russian Federation, 385017
        • Adygei Regional Clinical Oncology Dispensary/11
      • Moscow, Russian Federation, 105203
        • Scientific Medical Surgical Center n.a.I.V.Pyrogov/17
      • Moscow, Russian Federation, 105229
        • European Medical Center
      • Moscow, Russian Federation, 115478
        • RONC n.a.N.N.Blokhin/18
      • Moscow, Russian Federation, 129128
        • Сentral Clinical Hospital n.a. Semashko N.A./30
      • Moscow, Russian Federation, 443099
        • Moscow Scientific Research Oncology Institution n.a.P.A. Gertzen/37
      • Moscow, Russian Federation
        • Central Clinical Hospital of Department of Presidential Affairs
      • Nizhniy Novgorod, Russian Federation, 603003
        • Municipal Сlinical Hospital № 12/20
      • Novosibirsk, Russian Federation, 630087
        • Novosibirsk State Regional Clinical Hospital/23
      • Obninsk, Russian Federation, 249036
        • Medical Radiology Scientific Center/38
      • Omsk, Russian Federation, 644111
        • Omsk Regional Clinical Hospital/40
      • Omsk, Russian Federation, 644112
        • City Сlinical Hospital#1 n.a.Kabanov A.N./13
      • Orenburg, Russian Federation, 460000
        • Orenburg State Medical Academy/05
      • Rostov-on-Don, Russian Federation, 344037
        • Rostov Scientific Research Oncology Institution/01
      • Saint-Petersburg, Russian Federation, 197022
        • City Сlinical Oncological Dispensary/22
      • Saint-Petersburg, Russian Federation, 197110
        • City Сlinical Hospital#31/08
      • Saint-Petersburg, Russian Federation, 197758
        • Military-Medical Academy n.a. Kirova
      • Saint-Petersburg, Russian Federation, 197758
        • Scientific Research Oncological Institution n.a. Petrov N.N./29
      • Samara, Russian Federation, 443099
        • Samara State Medical University' Clinics/36
      • Smolensk, Russian Federation, 214025
        • Road Clinical Hospital on Rostov-Main Station OAO RZhD/06
      • Surgut, Russian Federation
        • Surgut Regional Clinical Hospital
      • Tula, Russian Federation, 300053
        • Tula Regional Clinical Hospital/21
      • Volgograd, Russian Federation, 400138
        • Volgograd Regional Clinical Oncology Dispensary#1/10
      • Vologda, Russian Federation, 160002
        • Vologda Regional Clinical Hospital/39
      • Yekaterinburg, Russian Federation
        • Yekaterinburg Regional Clinical Hospital #1
      • Yuzhno-Sakhalinsk, Russian Federation, 693010
        • Sakhalin Regional Oncology Dispensary/32

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma with planned combined Ribomustin and rituximab therapy

Description

Inclusion Criteria:

  • Doctor's decision to prescribe Ribomustin and rituximab combined therapy for the treatment of relapsed or refractory indolent B-cell Non-Hodgkin's Lymphoma (iNHL)
  • Informed Consent Form for personal data handling signed by the program participant, authorized by the Independent Ethics Committee
  • Eastern Cooperative Oncology Group (ECOG) status < 2.
  • Confirmed relapse or disease progression of B-cell CD20+ Non-Hodgkin's Lymphoma (lymphocytic, lymphocytoplasmocytic, follicular, marginal zone) after minimum one line of iNHL treatment
  • Patients with relapsed or refractory indolent B-cell Non-Hodgkin's Lymphoma with current or planned Ribomustin and rituximab combined therapy with following rituximab maintenance therapy

Exclusion Criteria:

  • Indolent Non-Hodgkin's Lymphoma transformation
  • Lymphoma with central nervous system (CNS) involvement
  • Presence of second malignant tumor.
  • Currently participating in any clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment.
  • Contraindications for Ribomustin usage in accordance with product label
  • Contradictions for rituximab usage in accordance with product label

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ribomustin and rituximab
Other: Ribomustin
Routine practice
Other Names:
  • bendamustine
Other: rituximab
Routine practice
Other Names:
  • Mabthera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate
Time Frame: 90 days post-treatment
90 days post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse drug reactions
Time Frame: up to 1 year
up to 1 year

Collaborators and Investigators

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

Sponsor

Astellas Pharma Europe B.V.

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

May 1, 2012

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

February 25, 2014

First Submitted That Met QC Criteria

February 25, 2014

First Posted (Estimate)

February 27, 2014

Study Record Updates

Last Update Posted (Estimate)

February 22, 2016

Last Update Submitted That Met QC Criteria

February 19, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RU-BEN-NI-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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