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

December 12, 2016 updated by: Barbara Botto, Azienda Ospedaliera Città della Salute e della Scienza di Torino

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

58

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma treated with Y90 Ibritumomab Tiuxetan Radioimmunotherapy Plus High-Dose Chemotherapy and Autologous Stem Cell Transplant

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Date of last follow-up for at least 18 months (up to 78 months)
Time to last follow-up or death
Date of last follow-up for at least 18 months (up to 78 months)
Progression Free Survival
Time Frame: From first response to last follow-up for at least 18 month (up to 78 months)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Investigators

  • Principal Investigator: Barbara Botto, MD, AOU Citta della Salute e della Scienza di Torino

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

December 12, 2016

First Submitted That Met QC Criteria

December 12, 2016

First Posted (Estimate)

December 14, 2016

Study Record Updates

Last Update Posted (Estimate)

December 14, 2016

Last Update Submitted That Met QC Criteria

December 12, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Oss_Z-BEAM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

paper publication

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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