Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly… (NCT02668653) | Clinical Trial Compass
CompletedPhase 3
Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)
United States539 participantsStarted 2016-09-01
Plain-language summary
Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research.
Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML).
Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Must be competent and able to comprehend, sign, and date an Ethics Committee (EC) or Institutional Review Board approved Informed Consent Form (ICF) before performance of any study-specific procedures or tests;
✓. Is ≥18 years or the minimum legal adult age (whichever is greater) and ≤75 years (at Screening);
✓. Newly diagnosed, morphologically documented primary AML or AML secondary to myelodysplastic syndrome or a myeloproliferative neoplasm, based on the World Health Organization (WHO) 2008 classification (at Screening);
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (at the time the participant signs their first ICF);
✓. Presence of FLT3-ITD activating mutation in bone marrow (allelic ratio of ≥3% FLT3-ITD/total FLT3);
✓. Participant is receiving standard "7+3" induction chemotherapy regimen as specified in the protocol;
✓. Adequate renal function defined as:
✓. Adequate hepatic function defined as:
Exclusion criteria
✕. Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or breakpoint cluster region-Abelson murine leukemia viral oncogene homolog 1 (BCR-ABL) positive leukemia (ie, chronic myelogenous leukemia in blast crisis); participants who undergo diagnostic workup for APL and treatment with all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy).
What they're measuring
1
Overall Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
Timeframe: Date of randomization to the date of death due to any cause, up to approximately 3 years after enrollment
✕. Diagnosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasms;
✕. Prior treatment for AML, except for the following allowances:
✕. Prior treatment with quizartinib or other FLT3-ITD inhibitors;
✕. Prior treatment with any investigational drug or device within 30 days prior to Randomization (within 2 weeks for investigational or approved immunotherapy) or currently participating in other investigational procedures;
✕. History of known CNS leukemia, including cerebrospinal fluid positive for AML blasts; lumbar puncture is recommended for participants with symptoms of CNS leukemia to rule out extramedullary CNS involvement;
✕. History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for at least 2 years;
✕. Uncontrolled or significant cardiovascular disease, including any of the following: