Chronic Lymphocytic LeukemiaNORMANCT02110394
Ribomustin in the First Line Therapy of Chronic Lymphocytic Leukemia
An observational study of Chronic Lymphocytic Leukemia, run by Astellas Pharma Europe B.V. at 34 sites in Russia.
Trial summary
Prospective multicenter observational non-interventional study to assess routine clinical practice of Bendamustine use in the first line therapy of chronic lymphocytic leukemia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- bendamustine and rituximab
- How many people
- 190 participants
- Where
- 34 sitesRussia
- Study dates
- Jun 2012to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
Russia34 sites
Alexandro-Mariinskaia Regional Clinical Hospital/13
Astrakhan, 414056
Republic Clinical Hospital n.a. N.A. Semashko
Buryatia, Ulan-Ude
Vologda Reginal Clinical Hospital #2
Cherepovets
Irkutsk Regional Clinical Hospital/08
Irkutsk, 664079
Kaliningrad City Clinical Hospital
Kaliningrad
Regional Clinical Hospital#1/04
Khabarovsk, 630009
District Cancer Center od Khanty -Mansiysk
Khanty-Mansiysk
National Medical Surgical Center n.a.N.I.Pirogov/15
Moscow, 105203
RONC n.a.N.N.Blokhin/21
Moscow, 115478
Сentral Clinical Hospital n.a.N.A.Semashko/20
Moscow, 129128
Central Clinical Hospital of Department of Presidential Affairs
Moscow
Haematology Centre at Main Military Clinical Hospital n.a. N.N. Burdenko
Moscow
Murmansk Regional Clinical Hospital n.a.P.A.Bayandin/31
Murmansk, 183047
Nizhniy Novgorod Regional Clinical Hospital n.a.N.A.Semashko/14
Nizhny Novgorod, 603126
Medical Radiology Scientific Center/23
Obninsk, 249036
Omsk Regional Clinical Hospital
Omsk
Orenburg State Medical Academy/011
Orenburg, 460000
Perm regional hospital
Perm
Karelia Republican Сlinical Hospital n.a.V.A.Baranov/32
Petrozavodsk, 185019
Pskov Regional Clinical Hospital
Pskov
Rostov Scientific Research Oncology Institution/03
Rostov-on-Don, 344037
Site 70001 Private Practice
Saint Petersburg, 197341
Military-Medical Academy n.a. Kirova
Saint Petersburg, 197758
Samara State Medical University' Clinics/28
Samara, 443099
Saratov State Medical University n.a. V.I.Razumovskiy
Saratov
Road Clinical Hospital on Smolensk station OAO RZhD/12
Smolensk, 214025
Komi Republican Oncology Dispensary /01
Syktyvkar, 167904
Tula Regional Clinical Hospital/07
Tula, 300053
Tyumen Regional Clinical Hospital#1/27
Tyumen, 625023
Regional Clinical Hospital/26
Ulyanovsk, 432063
Volgograd Regional Clinical Oncology Dispensary#1/25
Volgograd, 400138
Vologda Regional Clinical Hospital
Vologda
Yekaterinburg City Hospital #7
Yekaterinburg
Yekaterinburg Regional Clinical Hospital #1
Yekaterinburg
About this study
Official title: 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
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- bendamustine, rituximab
- Keywords
- observational, chronic lymphocytic leukemia, bendamustine
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bendamustineOther
Also called Ribomustin
Routine practice
rituximabOther
Also called Mabthera
Routine practice
| Study group | Role | What they receive |
|---|---|---|
| bendamustine and rituximab | Not described Receives: Other: bendamustine; Other: rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: Within 60-90 days after end of treatment
Secondary outcomes (7)
Adverse drug reactions
Measured: At all post-treatment visits (up to 30 days after end of treatment)
Treatment Failure (TF)
Measured: Within 60-90 days after end of treatment
Time to Progression (TTP)
Measured: 60 months
Progression-Free Survival (PFS)
Measured: 60 months
Relapse following complete or partial remission
Measured: 60 months
Overall survival
Measured: 60 months
Quality of Life of patients receiving Ribomustin therapy
Measured: At all post-treatment visits (up to 30 days after end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startJun 2012
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Manager, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110394
- Sponsor's protocol ID
- RU-BEN-NI-003
- Acronym
- NORMA
- Status last verified
- Jul 2016
- First submitted
- 8 Apr 2014
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Program for Evaluation of Ribomustin Use in the First Line Therapy of Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT02110394
- Acronym / sponsor ID
- NORMA / RU-BEN-NI-003
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- observational, chronic lymphocytic leukemia, bendamustine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective multicenter observational non-interventional study to assess routine clinical practice of Bendamustine use in the first line therapy of chronic lymphocytic leukemia
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bendamustine and rituximab | – | Other: bendamustine, Other: rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bendamustineAlso: RibomustinRoutine practice | Other | bendamustine and rituximab |
| rituximabAlso: MabtheraRoutine practice | Other | bendamustine and rituximab |
Primary outcome
Overall response rate
Time frame: Within 60-90 days after end of treatment
7 secondary outcomes
Adverse drug reactions
Time frame: 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
Time to Progression (TTP)
Time frame: 60 months
Progression-Free Survival (PFS)
Time frame: 60 months
Relapse following complete or partial remission
Time frame: 60 months
Overall survival
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Study Manager study chair
Astellas Pharma Europe B.V.
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia, run by Astellas Pharma Europe B.V. at 34 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: Within 60-90 days after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.