Ribomustin in the First Line Therapy of Chronic Lymphocytic Leukemia (NORMA)

July 4, 2016 updated by: Astellas Pharma Europe B.V.

Observational Program for Evaluation of Ribomustin Use in the First Line Therapy of Chronic Lymphocytic Leukemia

Prospective multicenter observational non-interventional study to assess routine clinical practice of Bendamustine use in the first line therapy of chronic lymphocytic leukemia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

190

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
      • Astrakhan', Russian Federation, 414056
        • Alexandro-Mariinskaia Regional Clinical Hospital/13
      • Cherepovets, Russian Federation
        • Vologda Reginal Clinical Hospital #2
      • Irkutsk, Russian Federation, 664079
        • Irkutsk Regional Clinical Hospital/08
      • Kaliningrad, Russian Federation
        • Kaliningrad City Clinical Hospital
      • Khabarovsk, Russian Federation, 630009
        • Regional Clinical Hospital#1/04
      • Khanty-Mansiysk, Russian Federation
        • District Cancer Center od Khanty -Mansiysk
      • Moscow, Russian Federation
        • Central Clinical Hospital of Department of Presidential Affairs
      • Moscow, Russian Federation, 105203
        • National Medical Surgical Center n.a.N.I.Pirogov/15
      • Moscow, Russian Federation, 115478
        • RONC n.a.N.N.Blokhin/21
      • Moscow, Russian Federation, 129128
        • Сentral Clinical Hospital n.a.N.A.Semashko/20
      • Moscow, Russian Federation
        • Haematology Centre at Main Military Clinical Hospital n.a. N.N. Burdenko
      • Murmansk, Russian Federation, 183047
        • Murmansk Regional Clinical Hospital n.a.P.A.Bayandin/31
      • Nizhniy Novgorod, Russian Federation, 603126
        • Nizhniy Novgorod Regional Clinical Hospital n.a.N.A.Semashko/14
      • Obninsk, Russian Federation, 249036
        • Medical Radiology Scientific Center/23
      • Omsk, Russian Federation
        • Omsk Regional Clinical Hospital
      • Orenburg, Russian Federation, 460000
        • Orenburg State Medical Academy/011
      • Perm, Russian Federation
        • Perm regional hospital
      • Petrozavodsk, Russian Federation, 185019
        • Karelia Republican Сlinical Hospital n.a.V.A.Baranov/32
      • Pskov, Russian Federation
        • Pskov Regional Clinical Hospital
      • Rostov-on-Don, Russian Federation, 344037
        • Rostov Scientific Research Oncology Institution/03
      • Saint-Petersburg, Russian Federation, 197758
        • Military-Medical Academy n.a. Kirova
      • Saint-Petersburg, Russian Federation, 197341
        • Site 70001 Private Practice
      • Samara, Russian Federation, 443099
        • Samara State Medical University' Clinics/28
      • Saratov, Russian Federation
        • Saratov State Medical University n.a. V.I.Razumovskiy
      • Smolensk, Russian Federation, 214025
        • Road Clinical Hospital on Smolensk station OAO RZhD/12
      • Syktyvkar, Russian Federation, 167904
        • Komi Republican Oncology Dispensary /01
      • Tula, Russian Federation, 300053
        • Tula Regional Clinical Hospital/07
      • Tyumen, Russian Federation, 625023
        • Tyumen Regional Clinical Hospital#1/27
      • Ul'yanovsk, Russian Federation, 432063
        • Regional Clinical Hospital/26
      • Volgograd, Russian Federation, 400138
        • Volgograd Regional Clinical Oncology Dispensary#1/25
      • Vologda, Russian Federation
        • Vologda Regional Clinical Hospital
      • Yekaterinburg, Russian Federation
        • Yekaterinburg Regional Clinical Hospital #1
      • Yekaterinburg, Russian Federation
        • Yekaterinburg City Hospital #7
    • Ulan-Ude
      • Buryatia, Ulan-Ude, Russian Federation
        • Republic Clinical Hospital n.a. N.A. Semashko

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 В-cell chronic lymphocytic leukemia under the care of a physician in the haematology/chemotherapy departments in 20-25 centers in the Russian Federation

Description

Inclusion Criteria:

  • Patients with chronic lymphocytic leukemia (CLL) with current or planned first line therapy with Ribomustin
  • Informed Consent Form for personal data handling signed by the program participant

Exclusion Criteria:

  • Any prior chemotherapy and/or radiotherapy and/or immunotherapy and/or any investigational agent for treatment of CLL
  • 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

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

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate
Time Frame: Within 60-90 days after end of treatment
Within 60-90 days after end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 60 months
60 months
Adverse drug reactions
Time Frame: At all post-treatment visits (up to 30 days after end of treatment)
At all post-treatment visits (up to 30 days after end of treatment)
Treatment Failure (TF)
Time Frame: Within 60-90 days after end of treatment
Within 60-90 days after end of treatment
Time to Progression (TTP)
Time Frame: 60 months
60 months
Progression-Free Survival (PFS)
Time Frame: 60 months
60 months
Relapse following complete or partial remission
Time Frame: 60 months
60 months
Quality of Life of patients receiving Ribomustin therapy
Time Frame: At all post-treatment visits (up to 30 days after end of treatment)
At all post-treatment visits (up to 30 days after end of treatment)

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

June 1, 2012

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

April 8, 2014

First Submitted That Met QC Criteria

April 8, 2014

First Posted (Estimate)

April 10, 2014

Study Record Updates

Last Update Posted (Estimate)

July 6, 2016

Last Update Submitted That Met QC Criteria

July 4, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RU-BEN-NI-003

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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