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OpenTrials
Completed

NCT Number: NCT02110394

Ribomustin in the First Line Therapy of Chronic Lymphocytic Leukemia

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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Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Republic Clinical Hospital n.a. N.A. Semashko, Buryatia, Ulan-Ude, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bendamustine

Other

Routine practice

Other names: Ribomustin

rituximab

Other

Routine practice

Other names: Mabthera

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)

Sponsors and collaborators

Lead sponsor

Astellas Pharma Europe B.V.

Industry

Registry information

Official study title

Observational Program for Evaluation of Ribomustin Use in the First Line Therapy of Chronic Lymphocytic Leukemia

Acronym: NORMA

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 10, 2014
Registry last updated
Jul 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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