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Trial record 97 of 317 for:    BENDAMUSTINE

Ribomustin in the First Line Therapy of Chronic Lymphocytic Leukemia (NORMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02110394
Recruitment Status : Completed
First Posted : April 10, 2014
Last Update Posted : July 6, 2016
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( 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

Condition or disease Intervention/treatment
Chronic Lymphocytic Leukemia Other: bendamustine Other: rituximab

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Study Type : Observational
Actual Enrollment : 190 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Program for Evaluation of Ribomustin Use in the First Line Therapy of Chronic Lymphocytic Leukemia
Study Start Date : June 2012
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015


Group/Cohort Intervention/treatment
bendamustine and rituximab Other: bendamustine
Routine practice
Other Name: Ribomustin

Other: rituximab
Routine practice
Other Name: Mabthera




Primary Outcome Measures :
  1. Overall response rate [ Time Frame: Within 60-90 days after end of treatment ]

Secondary Outcome Measures :
  1. Adverse drug reactions [ Time Frame: At all post-treatment visits (up to 30 days after end of treatment) ]
  2. Treatment Failure (TF) [ Time Frame: Within 60-90 days after end of treatment ]
  3. Time to Progression (TTP) [ Time Frame: 60 months ]
  4. Progression-Free Survival (PFS) [ Time Frame: 60 months ]
  5. Relapse following complete or partial remission [ Time Frame: 60 months ]
  6. Overall survival [ Time Frame: 60 months ]
  7. Quality of Life of patients receiving Ribomustin therapy [ Time Frame: At all post-treatment visits (up to 30 days after end of treatment) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with В-cell chronic lymphocytic leukemia under the care of a physician in the haematology/chemotherapy departments in 20-25 centers in the Russian Federation
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02110394


Locations
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Russian Federation
Republic Clinical Hospital n.a. N.A. Semashko
Buryatia, Ulan-Ude, Russian Federation
Alexandro-Mariinskaia Regional Clinical Hospital/13
Astrakhan', Russian Federation, 414056
Vologda Reginal Clinical Hospital #2
Cherepovets, Russian Federation
Irkutsk Regional Clinical Hospital/08
Irkutsk, Russian Federation, 664079
Kaliningrad City Clinical Hospital
Kaliningrad, Russian Federation
Regional Clinical Hospital#1/04
Khabarovsk, Russian Federation, 630009
District Cancer Center od Khanty -Mansiysk
Khanty-Mansiysk, Russian Federation
National Medical Surgical Center n.a.N.I.Pirogov/15
Moscow, Russian Federation, 105203
RONC n.a.N.N.Blokhin/21
Moscow, Russian Federation, 115478
Сentral Clinical Hospital n.a.N.A.Semashko/20
Moscow, Russian Federation, 129128
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
Murmansk Regional Clinical Hospital n.a.P.A.Bayandin/31
Murmansk, Russian Federation, 183047
Nizhniy Novgorod Regional Clinical Hospital n.a.N.A.Semashko/14
Nizhniy Novgorod, Russian Federation, 603126
Medical Radiology Scientific Center/23
Obninsk, Russian Federation, 249036
Omsk Regional Clinical Hospital
Omsk, Russian Federation
Orenburg State Medical Academy/011
Orenburg, Russian Federation, 460000
Perm regional hospital
Perm, Russian Federation
Karelia Republican Сlinical Hospital n.a.V.A.Baranov/32
Petrozavodsk, Russian Federation, 185019
Pskov Regional Clinical Hospital
Pskov, Russian Federation
Rostov Scientific Research Oncology Institution/03
Rostov-on-Don, Russian Federation, 344037
Site 70001 Private Practice
Saint-Petersburg, Russian Federation, 197341
Military-Medical Academy n.a. Kirova
Saint-Petersburg, Russian Federation, 197758
Samara State Medical University' Clinics/28
Samara, Russian Federation, 443099
Saratov State Medical University n.a. V.I.Razumovskiy
Saratov, Russian Federation
Road Clinical Hospital on Smolensk station OAO RZhD/12
Smolensk, Russian Federation, 214025
Komi Republican Oncology Dispensary /01
Syktyvkar, Russian Federation, 167904
Tula Regional Clinical Hospital/07
Tula, Russian Federation, 300053
Tyumen Regional Clinical Hospital#1/27
Tyumen, Russian Federation, 625023
Regional Clinical Hospital/26
Ul'yanovsk, Russian Federation, 432063
Volgograd Regional Clinical Oncology Dispensary#1/25
Volgograd, Russian Federation, 400138
Vologda Regional Clinical Hospital
Vologda, Russian Federation
Yekaterinburg City Hospital #7
Yekaterinburg, Russian Federation
Yekaterinburg Regional Clinical Hospital #1
Yekaterinburg, Russian Federation
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Investigators
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Study Chair: Clinical Study Manager Astellas Pharma Europe B.V.

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Responsible Party: Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier: NCT02110394     History of Changes
Other Study ID Numbers: RU-BEN-NI-003
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ):
observational
chronic lymphocytic leukemia
bendamustine
Additional relevant MeSH terms:
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Bendamustine Hydrochloride
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action