NCT02992223

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2014

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2016

Completed
Last Updated

December 14, 2016

Status Verified

December 1, 2016

Enrollment Period

1 year

First QC Date

December 12, 2016

Last Update Submit

December 12, 2016

Conditions

Refractory B-Cell Non-Hodgkin LymphomaRecurrent B-Cell Non-Hodgkin Lymphoma

Keywords

Aggressive B-cell non-Hodgkin LymphomaRelapsedRefractoryZevalinY90 Ibritumomab TiuxetanAutologous stem cell transplantBEAMRecurrent

Outcome Measures

Primary Outcomes (2)

  • Overall Survival

    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 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)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Patient with no complete data available for collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphoma, B-CellRecurrence

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Barbara Botto, MD

    A.O.U. Città della Salute e della Scienza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 12, 2016

First Posted

December 14, 2016

Study Start

July 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

December 14, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will share

paper publication