ACTIVE_NOT_RECRUITING

Long-term Follow-up (LTFU) of Patients Treated With Genome-edited Autologous Hematopoietic Stem and Progenitor Cells (HSPC)

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Conditions

Sickle Cell DiseaseGene therapygenome-edited hematopoietic stem and progenitor cellular therapysickle cellautologous transplantBCL11A

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

CADPT03A12001 is a prospective, multi-center study that is designed to follow all enrolled patients who have received treatment with OTQ923 for long-term safety and efficacy.

Official Title

Long-term Follow-up (LTFU) of Patients Treated With Genome-edited Autologous Hematopoietic Stem and Progenitor Cells (HSPC)

Quick Facts

Study Start:2024-04-16
Study Completion:2039-01-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06155500

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.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients must have received gene therapy treatment from the parent treatment protocol (CADPT03A12101).
  2. 2. Patients must provide informed consent prior to their entry into this study.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Novartis Pharmaceuticals
STUDY_DIRECTOR
Novartis Pharmaceuticals

Study Locations (Sites)

University of Chicago
Chicago, Illinois, 60637
United States
Memorial Sloan Kettering Cancer Ctr
New York, New York, 10065
United States
St Jude Childrens Research Hospital
Memphis, Tennessee, 38105
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

  • Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

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 Registration Dates

Study Start Date2024-04-16
Study Completion Date2039-01-11

Study Record Updates

Study Start Date2024-04-16
Study Completion Date2039-01-11

Terms related to this study

Keywords Provided by Researchers

  • Gene therapy
  • genome-edited hematopoietic stem and progenitor cellular therapy
  • sickle cell
  • autologous transplant
  • BCL11A

Additional Relevant MeSH Terms

  • Sickle Cell Disease