Phase
Condition
Neoplasms
Red Blood Cell Disorders
White Cell Disorders
Treatment
Ipilimumab
VAC85135
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Be positive for a CALR (calreticulin) mutation: Type 1 or Type 2; Type 1-like, orType 2-like may be considered with Sponsor approval; or positive for the JAK2V617F (Janus kinase 2 with valine 617 to phenylalanine mutation) mutation with HLA-A02:01 (human leukocyte antigens) per medical history or local testing
Have an Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1or 2
Have the following hematologic laboratory values: Leukocytes greater than or equalto (>=) 1.510^9 per liter, Neutrophils >=1.010^9 per liter, Platelets >=20*10^9per liter, Hemoglobin greater than (>) 7 gram per deciliter (g/dL)
Have the following chemistry laboratory values: Alanine aminotransferase (ALT): lessthan or equal to (<=) 3upper limit of normal (ULN), Aspartate aminotransferase (AST): <=3ULN, Total bilirubin: <=1.5*ULN, and glomerular filtration rate >=40milliliter per minute (mL/min)
A female participant of childbearing potential must agree to all the followingduring the study and for 6 months after the last dose of study treatment: use abarrier method of contraception, use a highly effective preferably user-independentmethod of contraception, not to donate eggs (ova, oocytes) or freeze for future usefor the purposes of assisted reproduction, not plan to become pregnant, not tobreast-feed
A male participant must agree to all the following during the study and for 90 daysafter the last dose of study treatment: wear a condom when engaging in any activitythat allows for passage of ejaculate to another person, not to father a child, notto donate sperm or freeze for future use for the purpose of reproduction
Exclusion
Exclusion Criteria:
History of any significant medical condition per investigators judgment (example:severe asthma/chronic obstructive pulmonary disease (COPD), poorly regulated heartcondition, insulin dependent diabetes mellitus)
Serious known clinically relevant allergies or earlier anaphylactic reactions
Currently pregnant or breastfeeding
Prior treatment with any Janus kinase 1/2 (JAK1/2) inhibitor
Known sensitivity or contraindications to the use of Ipilimumab per localprescribing information
Study Design
Connect with a study center
University Health Network (UHN) Princess Margaret Cancer Centre
Toronto, Ontario M5G 1Z5
CanadaSite Not Available
Hopital Saint-Louis
Paris, 75010
FranceSite Not Available
Clinica Univ. de Navarra
Pamplona, 31008
SpainSite Not Available
Hosp. Clinico Univ. de Salamanca
Salamanca, 37007
SpainSite Not Available
Hosp. Clinico Univ. de Valencia
Valencia, 46010
SpainSite Not Available
Guy's and St Thomas' Hospital
London, SE1 9RT
United KingdomSite Not Available
The Christie NHS Foundation Trust - Christie Hospital
Manchester, M20 4BX
United KingdomActive - Recruiting
The Christie NHS Foundation Trust Christie Hospital
Manchester, M20 4BX
United KingdomSite Not Available
Churchill Hospital
Oxford, OX3 7LE
United KingdomSite Not Available
The University of Alabama at Birmingham
Birmingham, Alabama 35233
United StatesSite Not Available
Mayo Clinic Cancer Center-Scottsdale
Phoenix, Arizona 85054
United StatesSite Not Available
City of Hope
Duarte, California 91010
United StatesSite Not Available
Moffitt Cancer Center
Tampa, Florida 33612
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
Mayo Clinic Rochester
Rochester, Minnesota 55902
United StatesSite Not Available
Rutgers University
Newark, New Jersey 07103
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Vanderbilt University Medical Center (VUMC) - Vanderbilt-Ingram Cancer Center (VICC)
Nashville, Tennessee 37232-0021
United StatesSite Not Available
MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
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