SUSPENDED

Study to Evaluate of EXG34217 in Patients With Telomere Biology Disorders With Bone Marrow Failure

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Conditions

Telomere ShorteningBone Marrow Failure

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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

This is a Phase I/II, open label, single center study to assess the safety and tolerability of EXG34217 in bone marrow failure patients with telomere biology disorders.

Official Title

A Phase I/II Study to Evaluate the Safety and Tolerability of EXG34217 in Patients With Telomere Biology Disorders With Bone Marrow Failure

Quick Facts

Study Start:2021-04-08
Study Completion:2027-10-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:SUSPENDED

Study ID

NCT04211714

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:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 12 years and above
  2. * Mild or moderate bone marrow failure defined by satisfying specific conditions.
  3. * Diagnosis of telomere biology disorders
  1. * Women of child bearing potential or breastfeeding.
  2. * Patients with cancer who are on active chemotherapeutic treatment.
  3. * Patients with severe bone marrow failure.
  4. * Clonal cytogenetic abnormalities associated with MDS or AML on bone marrow examination.
  5. * Uncontrolled bacterial, viral or fungal infections.
  6. * Prior allogeneic marrow or stem cell transplantation.
  7. * Patients who are not eligible for G-CSF and plerixafor dosing.
  8. * Patients who are not eligible for the apheresis.
  9. * Patients currently taking or have taken danazol and androgens within 60 days prior to Day 1.
  10. * Patients with any other clinically relevant acute or chronic diseases which could interfere with the patients' safety during the trial, expose them to undue risk, or which could interfere with study objectives.
  11. * Patients who have participated in another clinical trial with an investigational drug within the previous 30 days.

Contacts and Locations

Principal Investigator

Kasiani Myers, MD
PRINCIPAL_INVESTIGATOR
Cincinnati Children Hospital Medical Center

Study Locations (Sites)

Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
United States

Collaborators and Investigators

Sponsor: Elixirgen Therapeutics, Inc.

  • Kasiani Myers, MD, PRINCIPAL_INVESTIGATOR, Cincinnati Children Hospital Medical Center

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 Date2021-04-08
Study Completion Date2027-10-08

Study Record Updates

Study Start Date2021-04-08
Study Completion Date2027-10-08

Terms related to this study

Additional Relevant MeSH Terms

  • Telomere Shortening
  • Bone Marrow Failure