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Nucleoside Therapy in Patients With Telomere Biology Disorders

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Site contact updatedv8
  2. Start date changed from estimate of Sep 2025 to Sep 29, 2025v7
  3. Site contact updatedv6
  4. Site contact updatedv5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    • Eligibility criteria expanded, about 3 words
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Jun 2025 to Sep 2025
    • Eligibility criteria shortened, about 22 words
    • Study description expanded, about 20 words
    v3
  2. Eligibility criteria shortened, about 21 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to learn if a combination therapy of deoxycytidine (dC) plus deoxythymidine (dT) is safe in patients with telomere biology disorders. The main questions it aims to answer are: * Is the therapy safe with tolerable side effects in patients with telomere biology disorders? * Are problems with the bone marrow or blood or lungs changed after 6 months of dC+dT treatment in patients with telomere biology disorders? Participants will: * Take study drug by mouth three times daily for 24 weeks * Make approximately 2 visits to Boston Children's Hospital during the 24 weeks: once at the beginning of treatment and once at the end of treatment. * Go to a lab for a blood draw an additional 6 times during treatment. * Have 9 phone calls with a research nurse, including one 4 weeks after treatment ends. * Keep a diary to track doses of study drug that were taken or missed.
Trial Details
NCT Number NCT06817590
Lead Sponsor Suneet Agarwal
Conditions
(from sponsor)		 Telomere Biology Disorders, Dyskeratosis Congenita, Revesz Syndrome, Hoyeraal Hreidarsson Syndrome, Telomere Biology Disorders With Bone Marrow Failure, Interstitial Lung Disease Due to Systemic Disease (Telomere Biology Disorder), Pulmonary Fibrosis, Familial (Telomere Biology Disorder)
Related terms Bone Marrow Failure Disorders, Dyskeratosis Congenita, Hoyeraal Hreidarsson syndrome, Pulmonary Fibrosis, Revesz Debuse syndrome
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov