Ribomustin in the First Line Therapy of Chronic Lymphocytic Leukemia

NCT ID: NCT02110394

Last Updated: 2016-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

190 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-08-31

Brief Summary

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

Detailed Description

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Conditions

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Chronic Lymphocytic Leukemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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bendamustine and rituximab

bendamustine

Intervention Type OTHER

Routine practice

rituximab

Intervention Type OTHER

Routine practice

Interventions

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bendamustine

Routine practice

Intervention Type OTHER

rituximab

Routine practice

Intervention Type OTHER

Other Intervention Names

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Ribomustin Mabthera

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Europe B.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Study Manager

Role: STUDY_CHAIR

Astellas Pharma Europe B.V.

Locations

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Republic Clinical Hospital n.a. N.A. Semashko

Buryatia, Ulan-Ude, Russia

Site Status

Alexandro-Mariinskaia Regional Clinical Hospital/13

Astrakhan, , Russia

Site Status

Vologda Reginal Clinical Hospital #2

Cherepovets, , Russia

Site Status

Irkutsk Regional Clinical Hospital/08

Irkutsk, , Russia

Site Status

Kaliningrad City Clinical Hospital

Kaliningrad, , Russia

Site Status

Regional Clinical Hospital#1/04

Khabarovsk, , Russia

Site Status

District Cancer Center od Khanty -Mansiysk

Khanty-Mansiysk, , Russia

Site Status

National Medical Surgical Center n.a.N.I.Pirogov/15

Moscow, , Russia

Site Status

RONC n.a.N.N.Blokhin/21

Moscow, , Russia

Site Status

Сentral Clinical Hospital n.a.N.A.Semashko/20

Moscow, , Russia

Site Status

Central Clinical Hospital of Department of Presidential Affairs

Moscow, , Russia

Site Status

Haematology Centre at Main Military Clinical Hospital n.a. N.N. Burdenko

Moscow, , Russia

Site Status

Murmansk Regional Clinical Hospital n.a.P.A.Bayandin/31

Murmansk, , Russia

Site Status

Nizhniy Novgorod Regional Clinical Hospital n.a.N.A.Semashko/14

Nizhny Novgorod, , Russia

Site Status

Medical Radiology Scientific Center/23

Obninsk, , Russia

Site Status

Omsk Regional Clinical Hospital

Omsk, , Russia

Site Status

Orenburg State Medical Academy/011

Orenburg, , Russia

Site Status

Perm regional hospital

Perm, , Russia

Site Status

Karelia Republican Сlinical Hospital n.a.V.A.Baranov/32

Petrozavodsk, , Russia

Site Status

Pskov Regional Clinical Hospital

Pskov, , Russia

Site Status

Rostov Scientific Research Oncology Institution/03

Rostov-on-Don, , Russia

Site Status

Site 70001 Private Practice

Saint Petersburg, , Russia

Site Status

Military-Medical Academy n.a. Kirova

Saint Petersburg, , Russia

Site Status

Samara State Medical University' Clinics/28

Samara, , Russia

Site Status

Saratov State Medical University n.a. V.I.Razumovskiy

Saratov, , Russia

Site Status

Road Clinical Hospital on Smolensk station OAO RZhD/12

Smolensk, , Russia

Site Status

Komi Republican Oncology Dispensary /01

Syktyvkar, , Russia

Site Status

Tula Regional Clinical Hospital/07

Tula, , Russia

Site Status

Tyumen Regional Clinical Hospital#1/27

Tyumen, , Russia

Site Status

Regional Clinical Hospital/26

Ulyanovsk, , Russia

Site Status

Volgograd Regional Clinical Oncology Dispensary#1/25

Volgograd, , Russia

Site Status

Vologda Regional Clinical Hospital

Vologda, , Russia

Site Status

Yekaterinburg City Hospital #7

Yekaterinburg, , Russia

Site Status

Yekaterinburg Regional Clinical Hospital #1

Yekaterinburg, , Russia

Site Status

Countries

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Russia

Other Identifiers

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RU-BEN-NI-003

Identifier Type: -

Identifier Source: org_study_id

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