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
| Verified date | February 2016 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Russia: Ethics Committee |
| Study type | Observational |
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
| 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 |
Observational Model: Case-Only, Time Perspective: Prospective
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Europe B.V. |
Russian Federation,
| 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 |
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