Phase
Condition
White Cell Disorders
Neoplasms
Red Blood Cell Disorders
Treatment
INCA033989
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Life expectancy > 6 months.
Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease).
Existing documentation from a qualified local laboratory of CALR exon-9 mutation.
Participants with MF or ET as defined in the protocol.
Exclusion
Exclusion Criteria:
Presence of any hematological malignancy other than ET, PMF, or post-ET MF.
Prior history of major bleeding, or thrombosis within the last 3 months prior tostudy enrollment.
Participants with laboratory values exceeding the protocol defined thresholds.
Has undergone any prior allogenic or autologous stem-cell transplantation or suchtransplantation is planned.
Active invasive malignancy over the previous 2 years.
History of clinically significant or uncontrolled cardiac disease.
Active HBV/HCV or known history of HIV.
Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy,biological therapy, endocrine therapy, targeted therapy, antibody, orhypomethylating agent used to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
Participants undergoing treatment with G-CSF, GM-CSF, or TPO-R agonists at any timewithin 4 weeks before the first dose of study treatment.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Study Design
Connect with a study center
City of Hope Medical Center
Duarte, California 91010
United StatesActive - Recruiting
Stanford Cancer Institute
Palo Alto, California 94304
United StatesActive - Recruiting
University of Miami Health System
Miami, Florida 33136
United StatesActive - Recruiting
Moffitt Cancer Center
Tampa, Florida 33612
United StatesSite Not Available
The University of Kansas Cancer Center
Westwood, Kansas 66205
United StatesActive - Recruiting
Johns Hopkins Hospital
Baltimore, Maryland 21287
United StatesActive - Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United StatesActive - Recruiting
Washington University School of Medicine
Saint Louis, Missouri 63108
United StatesActive - Recruiting
Icahn School of Medicine At Mount Sinai
New York, New York 10029
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina 27157
United StatesActive - Recruiting
Cleveland Clinic
Cleveland, Ohio 44195
United StatesActive - Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesActive - Recruiting
Md Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
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