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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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