Clinical trial NCT02072967: Ribomustin in the Second Line Therapy of Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, Non-Hodgkin
Keywords: Relapsed
Refractory
Non-Hodgkin Lymphoma
Bendamustine
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-02-27
Enrollment: 97
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 Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma with planned combined Ribomustin and rituximab therapy

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


Eligibility criteria: 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

Primary outcomes:
measure: Overall response rate
timeFrame: 90 days post-treatment
Secondary outcomes:
measure: Adverse drug reactions
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Barnaul
country: Russian Federation
facility: City Clinical Hospital #8
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Oncology Dispensary/15
city: Cherepovets
country: Russian Federation
facility: Vologda Regional Clinical Hospital #2
city: Irkutsk
country: Russian Federation
facility: Regional Oncology Dispensary/35
city: Irkutsk
country: Russian Federation
facility: Irkutsk Regional Сlinical Hospital/31
city: Kaluga
country: Russian Federation
facility: Kaluga Regional Clinical Hospital/02
city: Khanty-Mansiysk
country: Russian Federation
facility: District Cancer center od Khanty -Mansiysk
city: Krasnoyarsk
country: Russian Federation
facility: City Сlinical Hospital#7/25
city: Krasnoyarsk
country: Russian Federation
facility: Regional Сlinical Hospital/12
city: Maykop
country: Russian Federation
facility: Adygei Regional Clinical Oncology Dispensary/11
city: Moscow
country: Russian Federation
facility: Scientific Medical Surgical Center n.a.I.V.Pyrogov/17
city: Moscow
country: Russian Federation
facility: European Medical Center
city: Moscow
country: Russian Federation
facility: RONC n.a.N.N.Blokhin/18
city: Moscow
country: Russian Federation
facility: Сentral Clinical Hospital n.a. Semashko N.A./30
city: Moscow
country: Russian Federation
facility: Moscow Scientific Research Oncology Institution n.a.P.A. Gertzen/37
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital of Department of Presidential Affairs
city: Nizhniy Novgorod
country: Russian Federation
facility: Municipal Сlinical Hospital № 12/20
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Regional Clinical Hospital/23
city: Obninsk
country: Russian Federation
facility: Medical Radiology Scientific Center/38
city: Omsk
country: Russian Federation
facility: Omsk Regional Clinical Hospital/40
city: Omsk
country: Russian Federation
facility: City Сlinical Hospital#1 n.a.Kabanov A.N./13
city: Orenburg
country: Russian Federation
facility: Orenburg State Medical Academy/05
city: Rostov-on-Don
country: Russian Federation
facility: Rostov Scientific Research Oncology Institution/01
city: Saint-Petersburg
country: Russian Federation
facility: City Сlinical Oncological Dispensary/22
city: Saint-Petersburg
country: Russian Federation
facility: City Сlinical Hospital#31/08
city: Saint-Petersburg
country: Russian Federation
facility: Military-Medical Academy n.a. Kirova
city: Saint-Petersburg
country: Russian Federation
facility: Scientific Research Oncological Institution n.a. Petrov N.N./29
city: Samara
country: Russian Federation
facility: Samara State Medical University' Clinics/36
city: Smolensk
country: Russian Federation
facility: Road Clinical Hospital on Rostov-Main Station OAO RZhD/06
city: Surgut
country: Russian Federation
facility: Surgut Regional Clinical Hospital
city: Tula
country: Russian Federation
facility: Tula Regional Clinical Hospital/21
city: Volgograd
country: Russian Federation
facility: Volgograd Regional Clinical Oncology Dispensary#1/10
city: Vologda
country: Russian Federation
facility: Vologda Regional Clinical Hospital/39
city: Yekaterinburg
country: Russian Federation
facility: Yekaterinburg Regional Clinical Hospital #1
city: Yuzhno-Sakhalinsk
country: Russian Federation
facility: Sakhalin Regional Oncology Dispensary/32
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Clinical Study Manager
role: STUDY_CHAIR
References: