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CompletedNCT02110394NORMAUpdated Jul 6, 2016

Ribomustin in the First Line Therapy of Chronic Lymphocytic Leukemia

An observational study in Chronic Lymphocytic Leukemia, sponsored by Astellas Pharma Europe B.V.. Completed at 34 sites in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-06.

Sponsored by Astellas Pharma Europe B.V. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
190
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Chronic Lymphocytic Leukemia

Keywords

  • observational
  • chronic lymphocytic leukemia
  • bendamustine
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 190 is above the median of 120 across 744 observational studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Astellas Pharma Europe B.V. is the lead sponsor of 93 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
190 participants (actual)
Patient registry
No

Groups and cohorts

  • bendamustine and rituximab

    Other: bendamustine · Other: rituximab

Interventions

  • Otherbendamustine

    Routine practice

    Also known as: Ribomustin

  • Otherrituximab

    Routine practice

    Also known as: Mabthera

06

What researchers measure

Primary outcomes

  1. Overall response rate

    Time frame: Within 60-90 days after end of treatment

Secondary outcomes

  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)

07

Study locations

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

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02110394
Lead sponsor
Astellas Pharma Europe B.V.
Responsible party
Sponsor
First posted
Apr 10, 2014
Start date
Jun 2012
Primary completion
Aug 2015
Completion
Aug 2015
Last update
Jul 6, 2016

Study contacts

Clinical Study Manager
study chair · Astellas Pharma Europe B.V.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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