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Completed

NCT Number: NCT02072967

Ribomustin in the Second Line Therapy 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

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Key information

Conditions

Lymphoma, Non-Hodgkin Disease Attributes Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

City Clinical Hospital #8, Barnaul, Russia

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Ribomustin

Other

Routine practice

Other names: bendamustine

rituximab

Other

Routine practice

Other names: Mabthera

Primary outcomes

  1. Overall response rate

    Time frame: 90 days post-treatment

Secondary outcomes

  1. Adverse drug reactions

    Time frame: up to 1 year

Sponsors and collaborators

Lead sponsor

Astellas Pharma Europe B.V.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 27, 2014
Registry last updated
Feb 22, 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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