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

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

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-10-31

Brief Summary

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Prospective multicenter observational non-interventional study to assess routine clinical practice of Bendamustine use in the second line therapy of relapsed or refractory indolent B-cell non-Hodgkin's lymphoma

Detailed Description

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Conditions

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Lymphoma, Non-Hodgkin

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Ribomustin and rituximab

Ribomustin

Intervention Type OTHER

Routine practice

rituximab

Intervention Type OTHER

Routine practice

Interventions

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Ribomustin

Routine practice

Intervention Type OTHER

rituximab

Routine practice

Intervention Type OTHER

Other Intervention Names

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bendamustine Mabthera

Eligibility Criteria

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Inclusion Criteria

* Doctor's decision to prescribe Ribomustin and rituximab combined therapy for the treatment of relapsed or refractory indolent B-cell Non-Hodgkin's Lymphoma (iNHL)
* 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

* Indolent Non-Hodgkin's Lymphoma transformation
* 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
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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City Clinical Hospital #8

Barnaul, , Russia

Site Status

Chelyabinsk Regional Oncology Dispensary/15

Chelyabinsk, , Russia

Site Status

Vologda Regional Clinical Hospital #2

Cherepovets, , Russia

Site Status

Regional Oncology Dispensary/35

Irkutsk, , Russia

Site Status

Irkutsk Regional Сlinical Hospital/31

Irkutsk, , Russia

Site Status

Kaluga Regional Clinical Hospital/02

Kaluga, , Russia

Site Status

District Cancer center od Khanty -Mansiysk

Khanty-Mansiysk, , Russia

Site Status

City Сlinical Hospital#7/25

Krasnoyarsk, , Russia

Site Status

Regional Сlinical Hospital/12

Krasnoyarsk, , Russia

Site Status

Adygei Regional Clinical Oncology Dispensary/11

Maykop, , Russia

Site Status

Scientific Medical Surgical Center n.a.I.V.Pyrogov/17

Moscow, , Russia

Site Status

European Medical Center

Moscow, , Russia

Site Status

RONC n.a.N.N.Blokhin/18

Moscow, , Russia

Site Status

Сentral Clinical Hospital n.a. Semashko N.A./30

Moscow, , Russia

Site Status

Moscow Scientific Research Oncology Institution n.a.P.A. Gertzen/37

Moscow, , Russia

Site Status

Central Clinical Hospital of Department of Presidential Affairs

Moscow, , Russia

Site Status

Municipal Сlinical Hospital № 12/20

Nizhny Novgorod, , Russia

Site Status

Novosibirsk State Regional Clinical Hospital/23

Novosibirsk, , Russia

Site Status

Medical Radiology Scientific Center/38

Obninsk, , Russia

Site Status

Omsk Regional Clinical Hospital/40

Omsk, , Russia

Site Status

City Сlinical Hospital#1 n.a.Kabanov A.N./13

Omsk, , Russia

Site Status

Orenburg State Medical Academy/05

Orenburg, , Russia

Site Status

Rostov Scientific Research Oncology Institution/01

Rostov-on-Don, , Russia

Site Status

City Сlinical Oncological Dispensary/22

Saint Petersburg, , Russia

Site Status

City Сlinical Hospital#31/08

Saint Petersburg, , Russia

Site Status

Military-Medical Academy n.a. Kirova

Saint Petersburg, , Russia

Site Status

Scientific Research Oncological Institution n.a. Petrov N.N./29

Saint Petersburg, , Russia

Site Status

Samara State Medical University' Clinics/36

Samara, , Russia

Site Status

Road Clinical Hospital on Rostov-Main Station OAO RZhD/06

Smolensk, , Russia

Site Status

Surgut Regional Clinical Hospital

Surgut, , Russia

Site Status

Tula Regional Clinical Hospital/21

Tula, , Russia

Site Status

Volgograd Regional Clinical Oncology Dispensary#1/10

Volgograd, , Russia

Site Status

Vologda Regional Clinical Hospital/39

Vologda, , Russia

Site Status

Yekaterinburg Regional Clinical Hospital #1

Yekaterinburg, , Russia

Site Status

Sakhalin Regional Oncology Dispensary/32

Yuzhno-Sakhalinsk, , Russia

Site Status

Countries

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Russia

Other Identifiers

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RU-BEN-NI-001

Identifier Type: -

Identifier Source: org_study_id

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