Ribomustin in the First Line Therapy of Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia Clinical Trial

— NORMA  

Official title:

Observational Program for Evaluation of Ribomustin Use in the First Line Therapy of Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02110394
• Other study ID #: RU-BEN-NI-003
• Status: Completed
• Phase: N/A
• First received: April 8, 2014
• Last updated: July 4, 2016
• Start date: June 2012
• Est. completion date: August 2015

Study information

• Verified date: July 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 first line therapy of chronic lymphocytic leukemia

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with chronic lymphocytic leukemia (CLL) with current or planned first line therapy with Ribomustin

• Informed Consent Form for personal data handling signed by the program participant

Exclusion Criteria:

• Any prior chemotherapy and/or radiotherapy and/or immunotherapy and/or any investigational agent for treatment of CLL

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Other:
• bendamustine
Routine practice
• rituximab
Routine practice

Locations

Country	Name	City	State
Russian Federation	Alexandro-Mariinskaia Regional Clinical Hospital/13	Astrakhan'
Russian Federation	Republic Clinical Hospital n.a. N.A. Semashko	Buryatia	Ulan-Ude
Russian Federation	Vologda Reginal Clinical Hospital #2	Cherepovets
Russian Federation	Irkutsk Regional Clinical Hospital/08	Irkutsk
Russian Federation	Kaliningrad City Clinical Hospital	Kaliningrad
Russian Federation	Regional Clinical Hospital#1/04	Khabarovsk
Russian Federation	District Cancer Center od Khanty -Mansiysk	Khanty-Mansiysk
Russian Federation	?entral Clinical Hospital n.a.N.A.Semashko/20	Moscow
Russian Federation	Central Clinical Hospital of Department of Presidential Affairs	Moscow
Russian Federation	Haematology Centre at Main Military Clinical Hospital n.a. N.N. Burdenko	Moscow
Russian Federation	National Medical Surgical Center n.a.N.I.Pirogov/15	Moscow
Russian Federation	RONC n.a.N.N.Blokhin/21	Moscow
Russian Federation	Murmansk Regional Clinical Hospital n.a.P.A.Bayandin/31	Murmansk
Russian Federation	Nizhniy Novgorod Regional Clinical Hospital n.a.N.A.Semashko/14	Nizhniy Novgorod
Russian Federation	Medical Radiology Scientific Center/23	Obninsk
Russian Federation	Omsk Regional Clinical Hospital	Omsk
Russian Federation	Orenburg State Medical Academy/011	Orenburg
Russian Federation	Perm regional hospital	Perm
Russian Federation	Karelia Republican ?linical Hospital n.a.V.A.Baranov/32	Petrozavodsk
Russian Federation	Pskov Regional Clinical Hospital	Pskov
Russian Federation	Rostov Scientific Research Oncology Institution/03	Rostov-on-Don
Russian Federation	Military-Medical Academy n.a. Kirova	Saint-Petersburg
Russian Federation	Site 70001 Private Practice	Saint-Petersburg
Russian Federation	Samara State Medical University' Clinics/28	Samara
Russian Federation	Saratov State Medical University n.a. V.I.Razumovskiy	Saratov
Russian Federation	Road Clinical Hospital on Smolensk station OAO RZhD/12	Smolensk
Russian Federation	Komi Republican Oncology Dispensary /01	Syktyvkar
Russian Federation	Tula Regional Clinical Hospital/07	Tula
Russian Federation	Tyumen Regional Clinical Hospital#1/27	Tyumen
Russian Federation	Regional Clinical Hospital/26	Ul'yanovsk
Russian Federation	Volgograd Regional Clinical Oncology Dispensary#1/25	Volgograd
Russian Federation	Vologda Regional Clinical Hospital	Vologda
Russian Federation	Yekaterinburg City Hospital #7	Yekaterinburg
Russian Federation	Yekaterinburg Regional Clinical Hospital #1	Yekaterinburg

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		Within 60-90 days after end of treatment	No
Secondary	Adverse drug reactions		At all post-treatment visits (up to 30 days after end of treatment)	No
Secondary	Treatment Failure (TF)		Within 60-90 days after end of treatment	No
Secondary	Time to Progression (TTP)		60 months	No
Secondary	Progression-Free Survival (PFS)		60 months	No
Secondary	Relapse following complete or partial remission		60 months	No
Secondary	Overall survival		60 months	No
Secondary	Quality of Life of patients receiving Ribomustin therapy		At all post-treatment visits (up to 30 days after end of treatment)	No