Ribomustin in the First Line Therapy of Chronic Lymphocytic Leukemia

Completed

• Conditions: Chronic Lymphocytic Leukemia
• Interventions: Other: bendamustine; Other: rituximab

• Registration Number: NCT02110394
• Lead Sponsor: Astellas Pharma Europe B.V.

Brief Summary

Prospective multicenter observational non-interventional study to assess routine clinical practice of Bendamustine use in the first line therapy of chronic lymphocytic leukemia

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2014-04-08
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-10
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-04
• Last Update Posted: 2016-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
bendamustine and rituximab	rituximab	-
bendamustine and rituximab	bendamustine	-

Primary Outcome Measures

Name	Time	Method
Overall response rate	Within 60-90 days after end of treatment

Secondary Outcome Measures

Name	Time	Method
Time to Progression (TTP)	60 months
Adverse drug reactions	At all post-treatment visits (up to 30 days after end of treatment)
Treatment Failure (TF)	Within 60-90 days after end of treatment
Progression-Free Survival (PFS)	60 months
Relapse following complete or partial remission	60 months
Overall survival	60 months
Quality of Life of patients receiving Ribomustin therapy	At all post-treatment visits (up to 30 days after end of treatment)

Trial Locations

Locations (34)

RONC n.a.N.N.Blokhin/21; 🇷🇺 Moscow, Russian Federation

Alexandro-Mariinskaia Regional Clinical Hospital/13; 🇷🇺 Astrakhan', Russian Federation

Vologda Reginal Clinical Hospital #2; 🇷🇺 Cherepovets, Russian Federation

Yekaterinburg Regional Clinical Hospital #1; 🇷🇺 Yekaterinburg, Russian Federation

Regional Clinical Hospital#1/04; 🇷🇺 Khabarovsk, Russian Federation

Rostov Scientific Research Oncology Institution/03; 🇷🇺 Rostov-on-Don, Russian Federation

Tula Regional Clinical Hospital/07; 🇷🇺 Tula, Russian Federation

Сentral Clinical Hospital n.a.N.A.Semashko/20; 🇷🇺 Moscow, Russian Federation

Irkutsk Regional Clinical Hospital/08; 🇷🇺 Irkutsk, Russian Federation

Kaliningrad City Clinical Hospital; 🇷🇺 Kaliningrad, Russian Federation

Republic Clinical Hospital n.a. N.A. Semashko; 🇷🇺 Buryatia, Ulan-Ude, Russian Federation

District Cancer Center od Khanty -Mansiysk; 🇷🇺 Khanty-Mansiysk, Russian Federation

Karelia Republican Сlinical Hospital n.a.V.A.Baranov/32; 🇷🇺 Petrozavodsk, Russian Federation

Military-Medical Academy n.a. Kirova; 🇷🇺 Saint-Petersburg, Russian Federation

Saratov State Medical University n.a. V.I.Razumovskiy; 🇷🇺 Saratov, Russian Federation

Yekaterinburg City Hospital #7; 🇷🇺 Yekaterinburg, 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

Medical Radiology Scientific Center/23; 🇷🇺 Obninsk, Russian Federation

Samara State Medical University' Clinics/28; 🇷🇺 Samara, Russian Federation

National Medical Surgical Center n.a.N.I.Pirogov/15; 🇷🇺 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

Omsk Regional Clinical Hospital; 🇷🇺 Omsk, Russian Federation

Perm regional hospital; 🇷🇺 Perm, Russian Federation

Pskov Regional Clinical Hospital; 🇷🇺 Pskov, Russian Federation

Site 70001 Private Practice; 🇷🇺 Saint-Petersburg, Russian Federation

Komi Republican Oncology Dispensary /01; 🇷🇺 Syktyvkar, Russian Federation

Regional Clinical Hospital/26; 🇷🇺 Ul'yanovsk, Russian Federation

Orenburg State Medical Academy/011; 🇷🇺 Orenburg, Russian Federation

Road Clinical Hospital on Smolensk station OAO RZhD/12; 🇷🇺 Smolensk, Russian Federation

Tyumen Regional Clinical Hospital#1/27; 🇷🇺 Tyumen, Russian Federation

Volgograd Regional Clinical Oncology Dispensary#1/25; 🇷🇺 Volgograd, Russian Federation

Vologda Regional Clinical Hospital; 🇷🇺 Vologda, Russian Federation