Summary

at San Francisco, California and other locations
study started
estimated completion

Description

Summary

This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult subjects exposed to Gene-modified (GM) T cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Subjects who received at least one GM T cell infusion, will be asked to roll-over to this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

Official Title

LONG-TERM FOLLOW-UP PROTOCOL FOR SUBJECTS TREATED WITH CAR T CELLS

Details

Subjects participating in this study will be followed from time of roll-over from the parent GM T protocol until 15 years after the last GMT infusion, withdrawal of consent, lost to follow-up, or death, whichever occurs first. Both local and central laboratory evaluations and safety assessments will be conducted during this trial. In addition, pediatric subjects will be monitored for growth, development and sexual maturity.

Stage 5 per Tanner Staging Criteria must be reached prior to study discontinuation.

Keywords

NeoplasmsLong-term follow upGene-Modified T CellsCAR T CellGene-modified (GM) T cell therapy

Eligibility

You can join if…

Subjects who meet the following criteria will be eligible to participate in the Long-Term

Follow-Up study:

  1. All adult and pediatric subjects who received at least one GM T cells infusion in a previous Celgene sponsored or Celgene alliance partner sponsored study, and have discontinued, or completed the post-treatment follow-up period in the parent treatment protocol, as applicable.
  2. Subject (and, parental/legal representative, when applicable) must understand and voluntarily sign an Informed Consent Form/Informed Assent Form prior to any study-related assessments/procedures being conducted.
  3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.

You CAN'T join if...

Locations

  • University of California, San Francisco- California not yet accepting patients
    San FranciscoCalifornia94143United States
  • Stanford Cancer Center not yet accepting patients
    StanfordCalifornia94305United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT03435796
Phase
Phase 2/3
Study Type
Interventional
Last Updated