Ribomustin in the Second Line Therapy of Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
Observational Program for Evaluation of Ribomustin and Rituximab Combined Therapy With Following Rituximab Maintenance of Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
1 other identifier
observational
97
1 country
35
Brief Summary
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
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 May 2012
Typical duration for all trials
35 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
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 25, 2014
CompletedFirst Posted
Study publicly available on registry
February 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFebruary 22, 2016
February 1, 2016
3.4 years
February 25, 2014
February 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall response rate
90 days post-treatment
Secondary Outcomes (1)
Adverse drug reactions
up to 1 year
Study Arms (1)
Ribomustin and rituximab
Interventions
Eligibility Criteria
Patients with Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma with planned combined Ribomustin and rituximab therapy
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
City Clinical Hospital #8
Barnaul, Russia
Chelyabinsk Regional Oncology Dispensary/15
Chelyabinsk, 454087, Russia
Vologda Regional Clinical Hospital #2
Cherepovets, Russia
Regional Oncology Dispensary/35
Irkutsk, 664035, Russia
Irkutsk Regional Сlinical Hospital/31
Irkutsk, 664079, Russia
Kaluga Regional Clinical Hospital/02
Kaluga, 248007, Russia
District Cancer center od Khanty -Mansiysk
Khanty-Mansiysk, Russia
City Сlinical Hospital#7/25
Krasnoyarsk, 660003, Russia
Regional Сlinical Hospital/12
Krasnoyarsk, 660022, Russia
Adygei Regional Clinical Oncology Dispensary/11
Maykop, 385017, Russia
Scientific Medical Surgical Center n.a.I.V.Pyrogov/17
Moscow, 105203, Russia
European Medical Center
Moscow, 105229, Russia
RONC n.a.N.N.Blokhin/18
Moscow, 115478, Russia
Сentral Clinical Hospital n.a. Semashko N.A./30
Moscow, 129128, Russia
Moscow Scientific Research Oncology Institution n.a.P.A. Gertzen/37
Moscow, 443099, Russia
Central Clinical Hospital of Department of Presidential Affairs
Moscow, Russia
Municipal Сlinical Hospital № 12/20
Nizhny Novgorod, 603003, Russia
Novosibirsk State Regional Clinical Hospital/23
Novosibirsk, 630087, Russia
Medical Radiology Scientific Center/38
Obninsk, 249036, Russia
Omsk Regional Clinical Hospital/40
Omsk, 644111, Russia
City Сlinical Hospital#1 n.a.Kabanov A.N./13
Omsk, 644112, Russia
Orenburg State Medical Academy/05
Orenburg, 460000, Russia
Rostov Scientific Research Oncology Institution/01
Rostov-on-Don, 344037, Russia
City Сlinical Oncological Dispensary/22
Saint Petersburg, 197022, Russia
City Сlinical Hospital#31/08
Saint Petersburg, 197110, Russia
Military-Medical Academy n.a. Kirova
Saint Petersburg, 197758, Russia
Scientific Research Oncological Institution n.a. Petrov N.N./29
Saint Petersburg, 197758, Russia
Samara State Medical University' Clinics/36
Samara, 443099, Russia
Road Clinical Hospital on Rostov-Main Station OAO RZhD/06
Smolensk, 214025, Russia
Surgut Regional Clinical Hospital
Surgut, Russia
Tula Regional Clinical Hospital/21
Tula, 300053, Russia
Volgograd Regional Clinical Oncology Dispensary#1/10
Volgograd, 400138, Russia
Vologda Regional Clinical Hospital/39
Vologda, 160002, Russia
Yekaterinburg Regional Clinical Hospital #1
Yekaterinburg, Russia
Sakhalin Regional Oncology Dispensary/32
Yuzhno-Sakhalinsk, 693010, 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
February 25, 2014
First Posted
February 27, 2014
Study Start
May 1, 2012
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
February 22, 2016
Record last verified: 2016-02