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Phase III Open-Label Randomized Study of Amonafide L-Malate in Combination With Cytarabine Compared to Daunorubicin in Combination With Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML)- The ACCEDE Study


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Secondary Acute Myeloid Leukemia (Secondary AML, sAML)

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Trial Information

Phase III Open-Label Randomized Study of Amonafide L-Malate in Combination With Cytarabine Compared to Daunorubicin in Combination With Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML)- The ACCEDE Study


Inclusion Criteria:



- Diagnosis of AML according to WHO diagnostic criteria (at least 20% blasts in the
peripheral blood or bone marrow), with FAB classification other than M3 (Acute
Promyelocytic Leukemia), documented by bone marrow aspiration and biopsy performed
within 14 days prior to administration of 1st dose of remission induction
chemotherapy;

- Either: Known and documented exposure to specific leukemogenic therapy of a specified
nature for a non-myeloid condition; OR Documented diagnosis of MDS according to WHO
criteria for at least 3 months prior to study entry, with prior bone marrow aspirate,
biopsy and peripheral blood smear documenting MDS available to be submitted for
subsequent central pathology review.

- Age 18 years or older;

- Eastern Cooperative Oncology Group (ECOG) performance score =< 2;

- Fertile sexually active patients (men and women) must use an effective method of
contraception which must be continued throughout the study.

- Women of childbearing potential must have a negative serum pregnancy test.

- Left Ventricular Ejection Fraction (LVEF) >= 50%, as determined by multiple-gated
acquisition scan (MUGA) or echocardiogram (ECHO) within 14 days prior to
administration of 1st dose of remission induction chemotherapy;

- Adequate renal function as evidenced by the following laboratory test, obtained
within 10 days prior to administration of 1st dose of remission induction
chemotherapy: Serum creatinine =< 1.5 x ULN;

- Adequate hepatic function as evidenced by the following laboratory tests, obtained
within 10 days prior to administration of 1st dose of remission induction
chemotherapy (unless attributed to hepatic involvement with AML): Total serum
bilirubin =< 1.5 x ULN;Serum AST and ALT =< 1.5 x ULN;

- Ability of the patient to participate fully in all aspects of this clinical trial;

- Written Informed Consent and HIPAA authorization (USA sites only) must be obtained
and documented.

Exclusion Criteria:

- Histologic diagnosis of FAB M3 Acute Promyelocytic Leukemia;

- Clinically active CNS leukemia;

- Prior induction therapy for AML;

- Known HIV positive;

- Known active hepatitis B or C, or any other active liver disease;

- Patients with parenchymal abnormality on screening chest x-ray must have no evidence
of pulmonary infection on chest tomography (CT) prior to starting remission induction
therapy.

- Any major surgery or radiation therapy within 4 weeks prior to study entry;

- Prior cytotoxic chemotherapy for MDS within 4 weeks prior to study entry (patients
with rapidly rising blast count may be enrolled within 4 weeks of prior cytotoxic
chemotherapy with waiver from the Medical Monitor);

- Persistent chronic non-hematologic toxicity (other than alopecia) greater than grade
1 from prior therapy for MDS;

- Serious concomitant illnesses (for example, pulmonary infiltrate, unstable angina or
myocardial infarction or stroke within 3 months prior to study entry, congestive
heart failure AHA class 2 or greater, uncontrolled hypertension, uncontrolled
diabetes, actively bleeding gastric ulcer, etc.), which in the investigator's opinion
would not make the patient a good candidate for the trial;

- Pregnant or breast feeding;

- History of clinically significant allergic reactions attributed to compounds of
similar chemical or biological composition to amonafide, cytarabine or daunorubicin;

- Prior enrollment in this trial;

- Any other known condition (e.g., familial, sociological, or geographical) or behavior
(including substance dependence or abuse, psychological or psychiatric illness),
which in the investigator's opinion would make the patient a poor candidate for the
trial.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of CR + CRi (which includes CRc and CRd) will be determined by assessing the proportion of patients who achieved CR or CRi among all evaluable patients.

Outcome Time Frame:

Course 1/Course 2 Day 37 bone marrow assessments and confirmation bone marrow 30 days later

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

509912

NCT ID:

NCT00715637

Start Date:

June 2007

Completion Date:

Related Keywords:

  • Secondary Acute Myeloid Leukemia (Secondary AML, sAML)
  • AML
  • Leukemia
  • MDS
  • Amonafide
  • Cytarabine
  • Daunorubicin
  • Lymphatic disorders
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Medical University of South CarolinaCharleston, South Carolina  29425-0721
James Graham Brown Cancer CenterLouisville, Kentucky  40202
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Rush University Medical CenterChicago, Illinois  60612-3824
Michigan State UniversityEast Lansing, Michigan  48824
Roger Williams Medical CenterProvidence, Rhode Island  02908-4735
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Oregon Health & Science UniversityPortland, Oregon  97201
Duke University Medical CenterDurham, North Carolina  27710
University of California San FranciscoSan Francisco, California  941104206
University of Colorado Health Sciences CenterDenver, Colorado  80262
UCLA Medical CenterLos Angeles, California  90095-7059
University of Michigan Cancer CenterAnn Arbor, Michigan  48109
Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Penn State Hershey Medical CenterHershey, Pennsylvania  17033
Cancer Center of the CarolinasGreenville, South Carolina  29615
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
Winship Cancer Institute, Emory UniversityAtlanta, Georgia  30322
Sarah Cannon Research InstituteNashville, Tennessee  37203
Rocky Mountain Blood and Marrow Transplant ProgramDenver, Colorado  80218
Northwestern University School of MedicineChicago, Illinois  60611
LSU Health Sciences Center, Feist-Weiller Cancer CenterShreveport, Louisiana  71130
Univ of Southern California Comprehensive Cancer CenterLos Angeles, California  90033
The Blood and Marrow Transplant Group of GAAtlanta, Georgia  30342
University of Iowa HospitalsIowa City, Iowa  52242
Northshore Hospital - Monter Cancer CenterLake Success, New York  11042
Taussig Cancer Center, Cleveland ClinicCleveland, Ohio  44195
Intermountain HealthcareSalt Lake City, Utah  84103