Clinical trial NCT02110394: Ribomustin in the First Line Therapy of Chronic Lymphocytic Leukemia
Official title: Observational Program for Evaluation of Ribomustin Use in the First Line Therapy of Chronic Lymphocytic Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukemia
Keywords: observational
chronic lymphocytic leukemia
bendamustine
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-04-10
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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


Eligibility criteria: 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

Primary outcomes:
measure: Overall response rate
timeFrame: Within 60-90 days after end of treatment
Secondary outcomes:
measure: Adverse drug reactions
timeFrame: At all post-treatment visits (up to 30 days after end of treatment)
measure: Treatment Failure (TF)
timeFrame: Within 60-90 days after end of treatment
measure: Time to Progression (TTP)
timeFrame: 60 months
measure: Progression-Free Survival (PFS)
timeFrame: 60 months
measure: Relapse following complete or partial remission
timeFrame: 60 months
measure: Overall survival
timeFrame: 60 months
measure: Quality of Life of patients receiving Ribomustin therapy
timeFrame: At all post-treatment visits (up to 30 days after end of treatment)
Other outcomes:
Locations:
city: Buryatia
country: Russian Federation
facility: Republic Clinical Hospital n.a. N.A. Semashko
state: Ulan-Ude
city: Astrakhan'
country: Russian Federation
facility: Alexandro-Mariinskaia Regional Clinical Hospital/13
city: Cherepovets
country: Russian Federation
facility: Vologda Reginal Clinical Hospital #2
city: Irkutsk
country: Russian Federation
facility: Irkutsk Regional Clinical Hospital/08
city: Kaliningrad
country: Russian Federation
facility: Kaliningrad City Clinical Hospital
city: Khabarovsk
country: Russian Federation
facility: Regional Clinical Hospital#1/04
city: Khanty-Mansiysk
country: Russian Federation
facility: District Cancer Center od Khanty -Mansiysk
city: Moscow
country: Russian Federation
facility: National Medical Surgical Center n.a.N.I.Pirogov/15
city: Moscow
country: Russian Federation
facility: RONC n.a.N.N.Blokhin/21
city: Moscow
country: Russian Federation
facility: Сentral Clinical Hospital n.a.N.A.Semashko/20
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital of Department of Presidential Affairs
city: Moscow
country: Russian Federation
facility: Haematology Centre at Main Military Clinical Hospital n.a. N.N. Burdenko
city: Murmansk
country: Russian Federation
facility: Murmansk Regional Clinical Hospital n.a.P.A.Bayandin/31
city: Nizhniy Novgorod
country: Russian Federation
facility: Nizhniy Novgorod Regional Clinical Hospital n.a.N.A.Semashko/14
city: Obninsk
country: Russian Federation
facility: Medical Radiology Scientific Center/23
city: Omsk
country: Russian Federation
facility: Omsk Regional Clinical Hospital
city: Orenburg
country: Russian Federation
facility: Orenburg State Medical Academy/011
city: Perm
country: Russian Federation
facility: Perm regional hospital
city: Petrozavodsk
country: Russian Federation
facility: Karelia Republican Сlinical Hospital n.a.V.A.Baranov/32
city: Pskov
country: Russian Federation
facility: Pskov Regional Clinical Hospital
city: Rostov-on-Don
country: Russian Federation
facility: Rostov Scientific Research Oncology Institution/03
city: Saint-Petersburg
country: Russian Federation
facility: Site 70001 Private Practice
city: Saint-Petersburg
country: Russian Federation
facility: Military-Medical Academy n.a. Kirova
city: Samara
country: Russian Federation
facility: Samara State Medical University' Clinics/28
city: Saratov
country: Russian Federation
facility: Saratov State Medical University n.a. V.I.Razumovskiy
city: Smolensk
country: Russian Federation
facility: Road Clinical Hospital on Smolensk station OAO RZhD/12
city: Syktyvkar
country: Russian Federation
facility: Komi Republican Oncology Dispensary /01
city: Tula
country: Russian Federation
facility: Tula Regional Clinical Hospital/07
city: Tyumen
country: Russian Federation
facility: Tyumen Regional Clinical Hospital#1/27
city: Ul'yanovsk
country: Russian Federation
facility: Regional Clinical Hospital/26
city: Volgograd
country: Russian Federation
facility: Volgograd Regional Clinical Oncology Dispensary#1/25
city: Vologda
country: Russian Federation
facility: Vologda Regional Clinical Hospital
city: Yekaterinburg
country: Russian Federation
facility: Yekaterinburg City Hospital #7
city: Yekaterinburg
country: Russian Federation
facility: Yekaterinburg Regional Clinical Hospital #1
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Clinical Study Manager
role: STUDY_CHAIR
References: