Ribomustin in the First Line Therapy of Chronic Lymphocytic Leukemia
NORMA
Observational Program for Evaluation of Ribomustin Use in the First Line Therapy of Chronic Lymphocytic Leukemia
1 other identifier
observational
190
1 country
34
Brief Summary
Prospective multicenter observational non-interventional study to assess routine clinical practice of Bendamustine use in the first line therapy of chronic lymphocytic leukemia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2012
Typical duration for all trials
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 8, 2014
CompletedFirst Posted
Study publicly available on registry
April 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedJuly 6, 2016
July 1, 2016
3.2 years
April 8, 2014
July 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall response rate
Within 60-90 days after end of treatment
Secondary Outcomes (7)
Adverse drug reactions
At all post-treatment visits (up to 30 days after end of treatment)
Treatment Failure (TF)
Within 60-90 days after end of treatment
Time to Progression (TTP)
60 months
Progression-Free Survival (PFS)
60 months
Relapse following complete or partial remission
60 months
- +2 more secondary outcomes
Study Arms (1)
bendamustine and rituximab
Interventions
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Republic Clinical Hospital n.a. N.A. Semashko
Buryatia, Ulan-Ude, Russia
Alexandro-Mariinskaia Regional Clinical Hospital/13
Astrakhan, 414056, Russia
Vologda Reginal Clinical Hospital #2
Cherepovets, Russia
Irkutsk Regional Clinical Hospital/08
Irkutsk, 664079, Russia
Kaliningrad City Clinical Hospital
Kaliningrad, Russia
Regional Clinical Hospital#1/04
Khabarovsk, 630009, Russia
District Cancer Center od Khanty -Mansiysk
Khanty-Mansiysk, Russia
National Medical Surgical Center n.a.N.I.Pirogov/15
Moscow, 105203, Russia
RONC n.a.N.N.Blokhin/21
Moscow, 115478, Russia
Сentral Clinical Hospital n.a.N.A.Semashko/20
Moscow, 129128, Russia
Central Clinical Hospital of Department of Presidential Affairs
Moscow, Russia
Haematology Centre at Main Military Clinical Hospital n.a. N.N. Burdenko
Moscow, Russia
Murmansk Regional Clinical Hospital n.a.P.A.Bayandin/31
Murmansk, 183047, Russia
Nizhniy Novgorod Regional Clinical Hospital n.a.N.A.Semashko/14
Nizhny Novgorod, 603126, Russia
Medical Radiology Scientific Center/23
Obninsk, 249036, Russia
Omsk Regional Clinical Hospital
Omsk, Russia
Orenburg State Medical Academy/011
Orenburg, 460000, Russia
Perm regional hospital
Perm, Russia
Karelia Republican Сlinical Hospital n.a.V.A.Baranov/32
Petrozavodsk, 185019, Russia
Pskov Regional Clinical Hospital
Pskov, Russia
Rostov Scientific Research Oncology Institution/03
Rostov-on-Don, 344037, Russia
Site 70001 Private Practice
Saint Petersburg, 197341, Russia
Military-Medical Academy n.a. Kirova
Saint Petersburg, 197758, Russia
Samara State Medical University' Clinics/28
Samara, 443099, Russia
Saratov State Medical University n.a. V.I.Razumovskiy
Saratov, Russia
Road Clinical Hospital on Smolensk station OAO RZhD/12
Smolensk, 214025, Russia
Komi Republican Oncology Dispensary /01
Syktyvkar, 167904, Russia
Tula Regional Clinical Hospital/07
Tula, 300053, Russia
Tyumen Regional Clinical Hospital#1/27
Tyumen, 625023, Russia
Regional Clinical Hospital/26
Ulyanovsk, 432063, Russia
Volgograd Regional Clinical Oncology Dispensary#1/25
Volgograd, 400138, Russia
Vologda Regional Clinical Hospital
Vologda, Russia
Yekaterinburg City Hospital #7
Yekaterinburg, Russia
Yekaterinburg Regional Clinical Hospital #1
Yekaterinburg, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Clinical Study Manager
Astellas Pharma Europe B.V.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2014
First Posted
April 10, 2014
Study Start
June 1, 2012
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
July 6, 2016
Record last verified: 2016-07