Ribomustin in the Second Line Therapy of Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02072967

Enrollment

Registered

2014-02-27

Start date

2012-05-31

Completion date

2015-10-31

Last updated

2016-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, Non-Hodgkin

Keywords

Relapsed, Refractory, Non-Hodgkin Lymphoma, Bendamustine

Brief 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

Interventions

OTHERRibomustin

Routine practice

OTHERrituximab

Routine practice

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Overall response rate	90 days post-treatment

Secondary

Measure	Time frame
Adverse drug reactions	up to 1 year

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026