Lymphoma, Non-HodgkinNCT02072967
Ribomustin in the Second Line Therapy of Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
An observational study of Lymphoma, Non-Hodgkin, run by Astellas Pharma Europe B.V. at 35 sites in Russia.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- Ribomustin and rituximab
- How many people
- 97 participants
- Where
- 35 sitesRussia
- Study dates
- May 2012to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma with planned combined Ribomustin and rituximab therapy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
Russia35 sites
City Clinical Hospital #8
Barnaul
Chelyabinsk Regional Oncology Dispensary/15
Chelyabinsk, 454087
Vologda Regional Clinical Hospital #2
Cherepovets
Regional Oncology Dispensary/35
Irkutsk, 664035
Irkutsk Regional Сlinical Hospital/31
Irkutsk, 664079
Kaluga Regional Clinical Hospital/02
Kaluga, 248007
District Cancer center od Khanty -Mansiysk
Khanty-Mansiysk
City Сlinical Hospital#7/25
Krasnoyarsk, 660003
Regional Сlinical Hospital/12
Krasnoyarsk, 660022
Adygei Regional Clinical Oncology Dispensary/11
Maykop, 385017
Scientific Medical Surgical Center n.a.I.V.Pyrogov/17
Moscow, 105203
European Medical Center
Moscow, 105229
RONC n.a.N.N.Blokhin/18
Moscow, 115478
Сentral Clinical Hospital n.a. Semashko N.A./30
Moscow, 129128
Moscow Scientific Research Oncology Institution n.a.P.A. Gertzen/37
Moscow, 443099
Central Clinical Hospital of Department of Presidential Affairs
Moscow
Municipal Сlinical Hospital № 12/20
Nizhny Novgorod, 603003
Novosibirsk State Regional Clinical Hospital/23
Novosibirsk, 630087
Medical Radiology Scientific Center/38
Obninsk, 249036
Omsk Regional Clinical Hospital/40
Omsk, 644111
City Сlinical Hospital#1 n.a.Kabanov A.N./13
Omsk, 644112
Orenburg State Medical Academy/05
Orenburg, 460000
Rostov Scientific Research Oncology Institution/01
Rostov-on-Don, 344037
City Сlinical Oncological Dispensary/22
Saint Petersburg, 197022
City Сlinical Hospital#31/08
Saint Petersburg, 197110
Military-Medical Academy n.a. Kirova
Saint Petersburg, 197758
Scientific Research Oncological Institution n.a. Petrov N.N./29
Saint Petersburg, 197758
Samara State Medical University' Clinics/36
Samara, 443099
Road Clinical Hospital on Rostov-Main Station OAO RZhD/06
Smolensk, 214025
Surgut Regional Clinical Hospital
Surgut
Tula Regional Clinical Hospital/21
Tula, 300053
Volgograd Regional Clinical Oncology Dispensary#1/10
Volgograd, 400138
Vologda Regional Clinical Hospital/39
Vologda, 160002
Yekaterinburg Regional Clinical Hospital #1
Yekaterinburg
Sakhalin Regional Oncology Dispensary/32
Yuzhno-Sakhalinsk, 693010
About this study
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
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
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- Ribomustin, rituximab
- Keywords
- Relapsed, Refractory, Non-Hodgkin Lymphoma, Bendamustine
- Medical subject headings
- Lymphoma, Non-Hodgkin, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibomustinOther
Also called bendamustine
Routine practice
rituximabOther
Also called Mabthera
Routine practice
| Study group | Role | What they receive |
|---|---|---|
| Ribomustin and rituximab | Not described Receives: Other: Ribomustin; Other: rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: 90 days post-treatment
Secondary outcomes (1)
Adverse drug reactions
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startMay 2012
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Manager, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072967
- Sponsor's protocol ID
- RU-BEN-NI-001
- Status last verified
- Feb 2016
- First submitted
- 25 Feb 2014
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02072967
- Acronym / sponsor ID
- RU-BEN-NI-001
- Conditions
- Lymphoma, Non-Hodgkin
- Keywords
- Relapsed, Refractory, Non-Hodgkin Lymphoma, Bendamustine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 27 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ribomustin and rituximab | – | Other: Ribomustin, Other: rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma with planned combined Ribomustin and rituximab therapy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RibomustinAlso: bendamustineRoutine practice | Other | Ribomustin and rituximab |
| rituximabAlso: MabtheraRoutine practice | Other | Ribomustin and rituximab |
Primary outcome
Overall response rate
Time frame: 90 days post-treatment
1 secondary outcome
Adverse drug reactions
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Study Manager study chair
Astellas Pharma Europe B.V.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, Non-Hodgkin, run by Astellas Pharma Europe B.V. at 35 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: 90 days post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2016.