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Prospective multicenter observational non-interventional study to assess routine clinical practice of Bendamustine use in the first line therapy of chronic lymphocytic leukemia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bendamustine and rituximab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bendamustine | Other | Routine practice |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | Within 60-90 days after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Study Manager | Astellas Pharma Europe B.V. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Republic Clinical Hospital n.a. N.A. Semashko | Buryatia | Ulan-Ude | Russia | |||
| Alexandro-Mariinskaia Regional Clinical Hospital/13 |
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| rituximab | Other | Routine practice |
|
|
| Time to Progression (TTP) |
| 60 months |
| 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) |
| Astrakhan |
| 414056 |
| Russia |
| Vologda Reginal Clinical Hospital #2 | Cherepovets | Russia |
| Irkutsk Regional Clinical Hospital/08 | Irkutsk | 664079 | Russia |
| Kaliningrad City Clinical Hospital | Kaliningrad | Russia |
| Regional Clinical Hospital#1/04 | Khabarovsk | 630009 | Russia |
| District Cancer Center od Khanty -Mansiysk | Khanty-Mansiysk | Russia |
| National Medical Surgical Center n.a.N.I.Pirogov/15 | Moscow | 105203 | Russia |
| RONC n.a.N.N.Blokhin/21 | Moscow | 115478 | Russia |
| Сentral Clinical Hospital n.a.N.A.Semashko/20 | Moscow | 129128 | Russia |
| Central Clinical Hospital of Department of Presidential Affairs | Moscow | Russia |
| Haematology Centre at Main Military Clinical Hospital n.a. N.N. Burdenko | Moscow | Russia |
| Murmansk Regional Clinical Hospital n.a.P.A.Bayandin/31 | Murmansk | 183047 | Russia |
| Nizhniy Novgorod Regional Clinical Hospital n.a.N.A.Semashko/14 | Nizhny Novgorod | 603126 | Russia |
| Medical Radiology Scientific Center/23 | Obninsk | 249036 | Russia |
| Omsk Regional Clinical Hospital | Omsk | Russia |
| Orenburg State Medical Academy/011 | Orenburg | 460000 | Russia |
| Perm regional hospital | Perm | Russia |
| Karelia Republican Сlinical Hospital n.a.V.A.Baranov/32 | Petrozavodsk | 185019 | Russia |
| Pskov Regional Clinical Hospital | Pskov | Russia |
| Rostov Scientific Research Oncology Institution/03 | Rostov-on-Don | 344037 | Russia |
| Site 70001 Private Practice | Saint Petersburg | 197341 | Russia |
| Military-Medical Academy n.a. Kirova | Saint Petersburg | 197758 | Russia |
| Samara State Medical University' Clinics/28 | Samara | 443099 | Russia |
| Saratov State Medical University n.a. V.I.Razumovskiy | Saratov | Russia |
| Road Clinical Hospital on Smolensk station OAO RZhD/12 | Smolensk | 214025 | Russia |
| Komi Republican Oncology Dispensary /01 | Syktyvkar | 167904 | Russia |
| Tula Regional Clinical Hospital/07 | Tula | 300053 | Russia |
| Tyumen Regional Clinical Hospital#1/27 | Tyumen | 625023 | Russia |
| Regional Clinical Hospital/26 | Ulyanovsk | 432063 | Russia |
| Volgograd Regional Clinical Oncology Dispensary#1/25 | Volgograd | 400138 | Russia |
| Vologda Regional Clinical Hospital | Vologda | Russia |
| Yekaterinburg City Hospital #7 | Yekaterinburg | Russia |
| Yekaterinburg Regional Clinical Hospital #1 | Yekaterinburg | Russia |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069461 | Bendamustine Hydrochloride |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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