RECRUITING

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

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

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.

Official Title

A Phase I Open Label Peptide Based Vaccine in Patients With Myeloproliferative Neoplasm Harboring CALR Mutations

Quick Facts

Study Start:2023-04-04
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05025488

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  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

Study Contact

Marina Kremyanskaya, MD, PhD
CONTACT
(212) 241-4106
marina.kremyanskaya@mssm.edu
Mikaela Dougherty
CONTACT
212-241-8839
mikaela.dougherty@mssm.edu

Principal Investigator

Marina Kremyanskaya, MD, PhD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Nina Bhardwaj, MD, PhD
STUDY_CHAIR
Icahn School of Medicine at Mount Sinai
Camelia Iancu-Rubin, PhD
STUDY_CHAIR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Marina Kremyanskaya

  • Marina Kremyanskaya, MD, PhD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai
  • Nina Bhardwaj, MD, PhD, STUDY_CHAIR, Icahn School of Medicine at Mount Sinai
  • Camelia Iancu-Rubin, PhD, STUDY_CHAIR, Icahn School of Medicine at Mount Sinai

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 Date2023-04-04
Study Completion Date2026-03

Study Record Updates

Study Start Date2023-04-04
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • CALR
  • Vaccine
  • MF
  • ET
  • peptide

Additional Relevant MeSH Terms

  • Myelofibrosis
  • Essential Thrombocythemia
  • MPN