Ribomustin in the Second Line Therapy of Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
NCT ID: NCT02072967
Last Updated: 2016-02-22
Study Results
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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COMPLETED
97 participants
OBSERVATIONAL
2012-05-31
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Ribomustin and rituximab
Ribomustin
Routine practice
rituximab
Routine practice
Interventions
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Ribomustin
Routine practice
rituximab
Routine practice
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed Consent Form for personal data handling signed by the program participant, authorized by the Independent Ethics Committee
* Eastern Cooperative Oncology Group (ECOG) status \< 2.
* Confirmed relapse or disease progression of B-cell CD20+ Non-Hodgkin's Lymphoma (lymphocytic, lymphocytoplasmocytic, follicular, marginal zone) after minimum one line of iNHL treatment
* Patients with relapsed or refractory indolent B-cell Non-Hodgkin's Lymphoma with current or planned Ribomustin and rituximab combined therapy with following rituximab maintenance therapy
Exclusion Criteria
* Lymphoma with central nervous system (CNS) involvement
* Presence of second malignant tumor.
* 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
* Contradictions for rituximab usage in accordance with product label
18 Years
ALL
No
Sponsors
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Astellas Pharma Europe B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Study Manager
Role: STUDY_CHAIR
Astellas Pharma Europe B.V.
Locations
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City Clinical Hospital #8
Barnaul, , Russia
Chelyabinsk Regional Oncology Dispensary/15
Chelyabinsk, , Russia
Vologda Regional Clinical Hospital #2
Cherepovets, , Russia
Regional Oncology Dispensary/35
Irkutsk, , Russia
Irkutsk Regional Сlinical Hospital/31
Irkutsk, , Russia
Kaluga Regional Clinical Hospital/02
Kaluga, , Russia
District Cancer center od Khanty -Mansiysk
Khanty-Mansiysk, , Russia
City Сlinical Hospital#7/25
Krasnoyarsk, , Russia
Regional Сlinical Hospital/12
Krasnoyarsk, , Russia
Adygei Regional Clinical Oncology Dispensary/11
Maykop, , Russia
Scientific Medical Surgical Center n.a.I.V.Pyrogov/17
Moscow, , Russia
European Medical Center
Moscow, , Russia
RONC n.a.N.N.Blokhin/18
Moscow, , Russia
Сentral Clinical Hospital n.a. Semashko N.A./30
Moscow, , Russia
Moscow Scientific Research Oncology Institution n.a.P.A. Gertzen/37
Moscow, , Russia
Central Clinical Hospital of Department of Presidential Affairs
Moscow, , Russia
Municipal Сlinical Hospital № 12/20
Nizhny Novgorod, , Russia
Novosibirsk State Regional Clinical Hospital/23
Novosibirsk, , Russia
Medical Radiology Scientific Center/38
Obninsk, , Russia
Omsk Regional Clinical Hospital/40
Omsk, , Russia
City Сlinical Hospital#1 n.a.Kabanov A.N./13
Omsk, , Russia
Orenburg State Medical Academy/05
Orenburg, , Russia
Rostov Scientific Research Oncology Institution/01
Rostov-on-Don, , Russia
City Сlinical Oncological Dispensary/22
Saint Petersburg, , Russia
City Сlinical Hospital#31/08
Saint Petersburg, , Russia
Military-Medical Academy n.a. Kirova
Saint Petersburg, , Russia
Scientific Research Oncological Institution n.a. Petrov N.N./29
Saint Petersburg, , Russia
Samara State Medical University' Clinics/36
Samara, , Russia
Road Clinical Hospital on Rostov-Main Station OAO RZhD/06
Smolensk, , Russia
Surgut Regional Clinical Hospital
Surgut, , Russia
Tula Regional Clinical Hospital/21
Tula, , Russia
Volgograd Regional Clinical Oncology Dispensary#1/10
Volgograd, , Russia
Vologda Regional Clinical Hospital/39
Vologda, , Russia
Yekaterinburg Regional Clinical Hospital #1
Yekaterinburg, , Russia
Sakhalin Regional Oncology Dispensary/32
Yuzhno-Sakhalinsk, , Russia
Countries
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Other Identifiers
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RU-BEN-NI-001
Identifier Type: -
Identifier Source: org_study_id
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