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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02992223
Recruitment Status : Completed
First Posted : December 14, 2016
Last Update Posted : December 14, 2016
Sponsor:
Information provided by (Responsible Party):
Barbara Botto, Azienda Ospedaliera Città della Salute e della Scienza di Torino

Brief 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

Condition or disease
Refractory B-Cell Non-Hodgkin Lymphoma Recurrent B-Cell Non-Hodgkin Lymphoma

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Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Study Start Date : July 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma




Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02992223


Sponsors and Collaborators
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Investigators
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Principal Investigator: Barbara Botto, MD AOU Città della Salute e della Scienza di Torino
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Responsible Party: Barbara Botto, MD, Azienda Ospedaliera Città della Salute e della Scienza di Torino
ClinicalTrials.gov Identifier: NCT02992223    
Other Study ID Numbers: Oss_Z-BEAM
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: paper publication
Keywords provided by Barbara Botto, Azienda Ospedaliera Città della Salute e della Scienza di Torino:
Aggressive B-cell non-Hodgkin Lymphoma
Relapsed
Refractory
Zevalin
Y90 Ibritumomab Tiuxetan
Autologous stem cell transplant
BEAM
Recurrent
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Aggression
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Behavioral Symptoms