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Protocol No.1718GCCC-S6Principal InvestigatorBaer, Maria
PhasePhase II
Age GroupAdult
TitleA Phase 2 Study of Entospletinib in NPM1 mutant/FLT3 ITD Wild Type AML Patients Age >/= 18 years
DescriptionThe purpose of this study is to determine the safety and acceptability of the experimental drug, entospletinib (ENTO, GS-9973), alone and in combination with standard Chemotherapy (Cohort A) Or alone or with Azacitidine (Aza, Vidaza) (Cohort B), that is approved by the US Food and Drug Administration (FDA) for MDS (a pre-leukemic condition) as well as a subset of AML subjects. Though not approved for all AML cases, azacitidine is often given for this condition.


For more information please see the clinicaltrials.gov weblink below
TreatmentEntospletinib, Azacitidine, Daunorubicin/Cytarabine
Key EligibilitySummary Inclusion Criteria
1. Adults, age >/= 60 years at the time of diagnosis with untreated AML positive for an NPM1 mutation but FLT3 ITD negative.
2. Cohort A requires 1) age <75 years; 2) ECOG performance status of 0-1, and 3) willingness to receive 7 + 3 intensive chemotherapy whereas Cohort B includes patients who do not meet the criteria outlined for Cohort A.
3. No chemotherapy for AML outside of HU for treatment of leukostasis or ATRA for initially suspected and ruled out APL is allowed
4. ECOG performance status 0, 1, or 2
5. AST < 5x ULN, ALT < 5x ULN, and total bilirubin < 2x ULN (except for patients with known Gilbert's syndrome)
6. Adequate renal function as defined by calculated creatinine clearance > 40 mL/min OR serum creatinine
Summary Exclusion Criteria
1. Isolated myeloid sarcoma
2. Acute promyelocytic leukemia (FAB M3)
3. Active CNS involvement by AML
4. Clinical signs/symptoms of leukostasis which has failed urgent therapy of at least 3 days duration including HU and/or leukapheresis
5. Known active HIV, active hepatitis B or active hepatitis C infection
6. Disseminated intravascular coagulopathy with active bleeding or signs of thrombosis
7. Patients who have received an investigational agent (for any indication) within 5 half-lives of the agent and until toxicity from this has resolved to grade 1 or less
8. Prior ENTO or SYK inhibitor for myeloid malignancy
9. Patients with psychological, familial, social, or geographic factors that otherwise preclude them from giving informed consent, following the protocol, or potentially hamper compliance with study treatment and follow-up
10. Patients with tuncontrolled intercurrent illness
11. Patients with uncontrolled infection

For more information please see the clinicaltrials.gov weblink below
Applicable Disease SitesAcute Myeloid Leukemia
Therapies InvolvedChemotherapy (NOS)
Enzyme Inhibitors
Drugs InvolvedCytarabine (Cytosine Arabinoside)
Entospletinib
Steroids
azacitidine
daunorubicin
hydroxyurea
StatusOpen
Treatment TypeTreatment
ClinicalTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT03013998
ContactGreenebaum Comprehensive Cancer Center: Veronica Kflu, MS Phone:+1 410-328-9416
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Email:veronica.kflu@umm.edu
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