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Mutant CALR-peptide Based Vaccine in Patients With Mutated CALR Myeloproliferative Neoplasm

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Final enrollment: 7 participants (planned 10) · Eligibility criteria expanded, about 28 words · Secondary endpoints: details revised at 3 of 7 entries · 1 more Show 4 more changesShow less
    • Final enrollment: 7 participants (planned 10)
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: details revised at 3 of 7 entries
    • Site details revised
  2. Primary and study completion dates: Mar 2026 to Mar 2027 Eligibility criteria expanded, about 14 words · Site contact updatedv5 Show 2 more changesShow less
    • Eligibility criteria expanded, about 14 words
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Jan 2024 to Mar 2026 Completion date: Jan 2025 to Mar 2026v4 Show 1 more changeShow less
    • Completion date: Jan 2025 to Mar 2026
  4. Lead sponsor: Michal Bar-Natan to Marina Kremyanskaya Trial status: Not Yet Recruiting to Recruiting · Start date changed from estimate of Jul 2022 to Apr 4, 2023 · Site details revisedv3 Show 3 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 2022 to Apr 4, 2023
    • Site details revised
  5. Primary completion date: Sep 6, 2022 to Jan 2024 Start date: Sep 6, 2021 to Jul 2022 · Completion date: Sep 6, 2023 to Jan 2025 · Site contact updated · 1 morev2 Show 4 more changesShow less
    • Start date: Sep 6, 2021 to Jul 2022
    • Completion date: Sep 6, 2023 to Jan 2025
    • Site contact updated
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 primary objective of this study is to assess the safety and tolerability of administrating mutated-CALR peptide Vaccine to patients with MPN. The researchers plan to enroll 10 patients over a 12 month period. Maximum length of participation in 80 weeks. Patients will be asked to complete questionnaires, bone marrow biopsies, research lab collection, and standard of care lab draw. This research will be taking place only at The Mount Sinai Hospital, specifically at the Ruttenberg Treatment Center.
Trial Details
NCT Number NCT05025488
Lead Sponsor Marina Kremyanskaya
Conditions Myelofibrosis, Essential Thrombocythemia, MPN
Enrollment 7 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov