Retrospective Analysis on Relapsed/Refractory Aggressive Non Hodgkin Lymphoma Treated With Z-BEAM Plus ASCT

Refractory B-Cell Non-Hodgkin Lymphoma Clinical Trial

Official title:

Retrospective Collection of Data on Patient With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma Treated With Y90 Ibritumomab Tiuxetan Radioimmunotherapy Plus High-Dose Chemotherapy and Autologous Stem Cell Transplant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02992223
• Other study ID #: Oss_Z-BEAM
• Status: Completed
• Phase: N/A
• First received: December 12, 2016
• Last updated: December 12, 2016
• Start date: July 2014
• Est. completion date: July 2015

Study information

• Verified date: December 2016
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Evaluate if Y90 Ibritumomab Tiuxetan Radioimmunotherapy in addition to standard high dose chemotherapy followed by autologous stem cell transplant could improve prognosis in patients affected by relapsed/refractory aggressive non Hodgkin lymphoma

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• High Risk Relapsed/refractory aggressive non-hodgkin lymphoma defined as:

• Progressive disease

• Early relapse (within 12 months from response)

• Recurrent relapse

• Treated with salvage chemotherapy followed by Y90 Ibritumomab Tiuxetan plus high-dose chemotherapy and Autologous stem cell transplant

• Age > 18 years

• Previous treatment with Rituximab

• Written informed consent

Exclusion Criteria:

• Patient with no complete data available for collection

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Aggression
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Recurrent B-Cell Non-Hodgkin Lymphoma
• Refractory B-Cell Non-Hodgkin Lymphoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Time to last follow-up or death	Date of last follow-up for at least 18 months (up to 78 months)	No
Primary	Progression Free Survival	Time from last response to nearest relapse or follow-up	From first response to last follow-up for at least 18 month (up to 78 months)	No