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NCT00651261

PHASE3

Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Sponsor: Alliance for Clinical Trials in Oncology

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the effects, good and/or bad, of a standard chemotherapy regimen for AML that includes the drugs daunorubicin and cytarabine combined with or without midostaurin (also known as PKC412), to find out which is better. This research is being done because it is unknown whether the addition of midostaurin to chemotherapy treatment is better than chemotherapy treatment alone. Midostaurin has been tested in over 400 patients and is being studied in a number of illnesses, including AML, colon cancer, and lung cancer. Midostaurin blocks an enzyme, produced by a gene known as FLT3, that may have a role in the survival and growth of AML cells. Not all leukemia cells will have the abnormal FLT3 gene. This study will focus only on patients with leukemia cells with the abnormal FLT3 gene.

Official title: A Phase III Randomized, Double-Blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy + Midostaurin (PKC412) (IND #101261) or Placebo in Newly Diagnosed Patients < 60 Years of Age With FLT3 Mutated Acute Myeloid Leukemia (AML)

Key Details

Gender

All

Age Range

18 Years - 59 Years

Study Type

INTERVENTIONAL

Enrollment

717

Start Date

2008-04

Completion Date

2022-03-28

Last Updated

2026-10-21

Healthy Volunteers

Conditions

Leukemia

Interventions

DRUG

cytarabine

Given IV

DRUG

daunorubicin

Given IV

DRUG

midostaurin

Given orally

OTHER

placebo

Given orally

DRUG

dexamethasone acetate

ocular medication administration

1. Documentation of Disease: * Unequivocal diagnosis of AML ( \> 20% blasts in the bone marrow based on the WHO classification), excluding M3 (acute promyelocytic leukemia). Patients with neurologic symptoms suggestive of CNS leukemia are recommended to have a lumbar puncture. Patients whose CSF is positive for AML blasts are not eligible. * Documented FLT3 mutation (ITD or point mutation), determined by analysis in a protocol- designated FLT3 screening laboratory. 2. Age Requirement: * Age ≥ 18 and \< 60 years 3. Prior Therapy: * No prior chemotherapy for leukemia or myelodysplasia with the following exceptions: * emergency leukapheresis * emergency treatment for hyperleukocytosis with hydroxyurea for ≤ 5 days * cranial RT for CNS leukostasis (one dose only) * growth factor/cytokine support * AML patients with a history of antecedent myelodysplasia (MDS) remain eligible for treatment on this trial, but must not have had prior cytotoxic therapy (e.g., azacitidine or decitabine) * Patients who have developed therapy related AML after prior RT or chemotherapy for another cancer or disorder are not eligible. 4. Cardiac Function: Patients with symptomatic congestive heart failure are not eligible. 5. Initial Laboratory Value: Total bilirubin \< 2.5 x ULN (Upper Limit of Normal) 6. Pregnancy and Nursing Status: * Non-pregnant and non-nursing due to the unknown teratogenic potential of midostaurin in humans, pregnant or nursing patients may not be enrolled. * Women of childbearing potential must have a negative serum or urine pregnancy test within a sensitivity of at least 50 mIU/mL within 16 days prior to registration. * Women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or commit to TWO acceptable methods of birth control: * one highly effective method (eg, IUD, hormonal (non-oral contraceptive), tubal ligation, or partner's vasectomy) and * one additional effective method (e.g., latex condom, diaphragm or cervical cap) * The two acceptable methods of birth control must be used AT THE SAME TIME, before beginning midostaurin/placebo therapy and continuing for 12 weeks after completion of all therapy. * Note that oral contraceptives are not considered a high effective method because of the possibility of a drug interaction with midostaurin. * Women of childbearing potential is defined as a sexually active mature woman who has not undergone a hysterectomy or who has not had menses at any time in the preceding 24 consecutive months. * Men must agree not to father a child and must use a latex condom during any sexual contact with women of childbearing potential while taking midostaurin/placebo and for 12 weeks after therapy is stopped, even if they have undergone a successful vasectomy.

Locations (176)

UAB Comprehensive Cancer Center

Birmingham, Alabama, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

University of California Davis Cancer Center

Sacramento, California, United States

Aurora Presbyterian Hospital

Aurora, Colorado, United States

Boulder Community Hospital

Boulder, Colorado, United States

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, United States

St. Anthony Central Hospital