CALR Exon 9 Mutant Peptide Vaccine to Patients With CALR-mutant Myeloproliferative Neoplasms
A Phase-1-first in Man Study in Patients With CALR-mutant Myeloproliferative Neoplasms by Vaccinating With CALR Exon 9 Mutant Peptide
2 other identifiers
interventional
10
1 country
1
Brief Summary
A phase-I-first in man study in patients with calreticulin(CALR)-mutant MPN by vaccinating with exon 9 mutated peptide with the adjuvant Montanide ISA-51 to monitor safety and toxicity and the immunological response to vaccination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2018
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2018
CompletedStudy Start
First participant enrolled
June 20, 2018
CompletedFirst Posted
Study publicly available on registry
June 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedJuly 13, 2023
July 1, 2023
1.7 years
June 11, 2018
July 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events evaluated by CTCAE 4.03
Adverse events are graded 1-5 according to the criteria
1 year
Secondary Outcomes (1)
Immune responses
1 year
Other Outcomes (4)
Mutational status
1 year
Bone marrow response
1 year
mutational landscape change
1 year
- +1 more other outcomes
Study Arms (1)
36 aminoacid CALR exon 9 mutated peptide
EXPERIMENTAL15 vaccines, over the course of 1 year
Interventions
200 ug CALRLong36 peptide in water mixed with 500ul montanide
Eligibility Criteria
You may qualify if:
- \. Diagnosis of essential thrombocythemia, post essential thrombocythemia myelofibrosis, prefibrotic myelofibrosis or primary myelofibrosis according to the World Health Organization criteria33 2. Verified mutation in CALR exon 9. 4. Performance status ≤ 2 (ECOG-scale) 5. Expected survival \> 3 months 6. Sufficient bone marrow function, i.e.
- Leucocytes ≥ 1,5 x 109
- Granulocytes ≥ 1,0 x 109
- Thrombocytes ≥ 20 x 109
- Hemoglobin ≥ 7 mmol/L 7. Creatinine \< 2.5 upper normal limit, i.e. \< 300 µmol/l 8. Sufficient liver function, i.e.
- a. Alanine aminotransferase \< 2.5 upper normal limit, i.e. ALAT \<112 U/l b. Bilirubin \< 30 U/l 9. For women: Agreement to use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for at least 120 days after the last treatment.
- \. For men: Agreement to use contraceptive measures and agreement to refrain from donating sperm.
You may not qualify if:
- Other malignancies in the medical history excluding squamous cell carcinoma. Patients cured for another malignant disease with no sign of relapse three years after ended treatment is allowed to enter the protocol.
- Significant medical condition per investigators judgement e.g. severe Asthma/chronic obstructive pulmonary disease , poorly regulated heart condition, insulin dependent diabetes mellitus.
- Acute or chronic viral or bacterial infection e.g. HIV, hepatitis or tuberculosis
- Serious known allergies or earlier anaphylactic reactions.
- Known sensibility to Montanide ISA-51
- Any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis etc.
- Pregnant and breastfeeding women.
- Fertile women not using secure contraception with a failure rate less than \< 1%
- Patients taking immune suppressive medications incl. corticosteroids and methotrexate at the time of enrollment
- Psychiatric disorders that per investigator judgment could influence compliance.
- Treatment with other experimental drugs
- Treatment with other anti-cancer drugs - except interferon (IFN)-a, hydroxyurea or anagrelide.
- Treatment with ruxolitinib.
- Treatment with chemotherapy or immune therapy (excluding IFN-a, hydroxyurea or anagrelide) within the last 28 days.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inge Marie Svanelead
Study Sites (1)
Herlev Hospital
Herlev, Capital Region, 2730, Denmark
Related Publications (1)
Handlos Grauslund J, Holmstrom MO, Jorgensen NG, Klausen U, Weis-Banke SE, El Fassi D, Schollkopf C, Clausen MB, Gjerdrum LMR, Breinholt MF, Kjeldsen JW, Hansen M, Koschmieder S, Chatain N, Novotny GW, Petersen J, Kjaer L, Skov V, Met O, Svane IM, Hasselbalch HC, Andersen MH. Therapeutic Cancer Vaccination With a Peptide Derived From the Calreticulin Exon 9 Mutations Induces Strong Cellular Immune Responses in Patients With CALR-Mutant Chronic Myeloproliferative Neoplasms. Front Oncol. 2021 Feb 26;11:637420. doi: 10.3389/fonc.2021.637420. eCollection 2021.
PMID: 33718228DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacob H Grauslund, MD
Center for Cancer Immune Therapy, Denmark
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, MD, PhD
Study Record Dates
First Submitted
June 11, 2018
First Posted
June 25, 2018
Study Start
June 20, 2018
Primary Completion
February 20, 2020
Study Completion
April 30, 2021
Last Updated
July 13, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share