IRB #

IRB00010674

Title

A Phase 3 Open-Label Randomized Study of Quizartinib (AC220) Monotherapy Versus Salvage Chemotherapy in Subjects with FLT3-ITD Positive Acute Myeloid Leukemia (AML) Refractory to or Relapsed after First-Line Treatment With or Without Hematopoietic Stem Cell Transplantation (HSCT) Consolidation

Principal Investigator

Elie Traer

Study Purpose

The purpose of this study is to compare the effects, good and/or bad of the study drug versus standard chemotherapy on Acute Myeloid Leukemia. The study drug is quizartinib, and the three standard chemotherapy regimens are: LoDAC (low dose cytarabine) (cytarabine is also called Ara-C), MEC (mitoxantrone, etoposide, cytarabine), or FLAG-IDA (fludarabine, idarubicin, cytarabine, granulocyte colony stimulating factor (G-CSF)).

Medical Condition(s)

Acute Myeloid Leukemia that has not responded to previous treatment and that has a genetic mutation of FLT3-ITD.

Eligibility Criteria

Participants must have:
-Age ≥18 years
-Morphologically documented primary AML or AML secondary to myelodysplastic
syndrome (MDS)
-Refractory or relapsed AML after first-line therapy, with or without stem cell transplant
-Presence of the FLT3-ITD activating mutation in bone marrow or peripheral blood
-Discontinuation of prior AML treatment before the start of study treatment
-Adequate routine blood tests

Participants must NOT have:
-Acute promyelocytic leukemia (AML subtype M3)
-AML secondary to prior chemotherapy for other neoplasms, except AML secondary
to prior MDS
-History of another malignancy, unless the candidate has been disease-free for at least 5 years
-Clinically significant GVHD or GVHD requiring initiation of treatment or treatment
escalation within 21 days
-History of, or current, central nervous system involvement with AML
-Prior treatment with quizartinib or participated in a prior quizartinib study
-Known presence of a FLT3-D835 mutation at study enrollment
-Major surgery within 4 weeks prior to screening
-Radiation therapy within 4 weeks prior to screening
-Uncontrolled or significant cardiovascular disease
-Active infection not well controlled by antibacterial or antiviral therapy
-Known infection with human immunodeficiency virus, or active hepatitis B or C, or
other active clinically relevant liver disease
-Unwillingness to receive infusion of blood products according to the protocol
-Positive pregnancy test result
-Breastfeeding

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

Depending on the treatment arm, participants may be in treatment at a minimum for 2 months to a maximum of continuous treatment until their cancer gets worse. Participants will be in follow-up for life.

Minors Included

No

Contact

Clinical Trials Information Line: Phone 503-494-1080 or trials@ohsu.edu

Sponsor

Ambit Biosciences Corporation

Recruitment End

01/01/2030

Compensation Provided

No


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