Ribomustin in the Second Line Therapy of Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma

Lymphoma, Non-Hodgkin Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02072967
• Other study ID #: RU-BEN-NI-001
• Status: Completed
• Phase: N/A
• First received: February 25, 2014
• Last updated: February 19, 2016
• Start date: May 2012
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin

Intervention

Other:
• Ribomustin
Routine practice
• rituximab
Routine practice

Locations

Country	Name	City	State
Russian Federation	City Clinical Hospital #8	Barnaul
Russian Federation	Chelyabinsk Regional Oncology Dispensary/15	Chelyabinsk
Russian Federation	Vologda Regional Clinical Hospital #2	Cherepovets
Russian Federation	Irkutsk Regional ?linical Hospital/31	Irkutsk
Russian Federation	Regional Oncology Dispensary/35	Irkutsk
Russian Federation	Kaluga Regional Clinical Hospital/02	Kaluga
Russian Federation	District Cancer center od Khanty -Mansiysk	Khanty-Mansiysk
Russian Federation	City ?linical Hospital#7/25	Krasnoyarsk
Russian Federation	Regional ?linical Hospital/12	Krasnoyarsk
Russian Federation	Adygei Regional Clinical Oncology Dispensary/11	Maykop
Russian Federation	?entral Clinical Hospital n.a. Semashko N.A./30	Moscow
Russian Federation	Central Clinical Hospital of Department of Presidential Affairs	Moscow
Russian Federation	European Medical Center	Moscow
Russian Federation	Moscow Scientific Research Oncology Institution n.a.P.A. Gertzen/37	Moscow
Russian Federation	RONC n.a.N.N.Blokhin/18	Moscow
Russian Federation	Scientific Medical Surgical Center n.a.I.V.Pyrogov/17	Moscow
Russian Federation	Municipal ?linical Hospital ? 12/20	Nizhniy Novgorod
Russian Federation	Novosibirsk State Regional Clinical Hospital/23	Novosibirsk
Russian Federation	Medical Radiology Scientific Center/38	Obninsk
Russian Federation	City ?linical Hospital#1 n.a.Kabanov A.N./13	Omsk
Russian Federation	Omsk Regional Clinical Hospital/40	Omsk
Russian Federation	Orenburg State Medical Academy/05	Orenburg
Russian Federation	Rostov Scientific Research Oncology Institution/01	Rostov-on-Don
Russian Federation	City ?linical Hospital#31/08	Saint-Petersburg
Russian Federation	City ?linical Oncological Dispensary/22	Saint-Petersburg
Russian Federation	Military-Medical Academy n.a. Kirova	Saint-Petersburg
Russian Federation	Scientific Research Oncological Institution n.a. Petrov N.N./29	Saint-Petersburg
Russian Federation	Samara State Medical University' Clinics/36	Samara
Russian Federation	Road Clinical Hospital on Rostov-Main Station OAO RZhD/06	Smolensk
Russian Federation	Surgut Regional Clinical Hospital	Surgut
Russian Federation	Tula Regional Clinical Hospital/21	Tula
Russian Federation	Volgograd Regional Clinical Oncology Dispensary#1/10	Volgograd
Russian Federation	Vologda Regional Clinical Hospital/39	Vologda
Russian Federation	Yekaterinburg Regional Clinical Hospital #1	Yekaterinburg
Russian Federation	Sakhalin Regional Oncology Dispensary/32	Yuzhno-Sakhalinsk

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe B.V.

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		90 days post-treatment	No
Secondary	Adverse drug reactions		up to 1 year	Yes