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Phase IIB, Multicenter, Randomized, Open-Label Trial Of CPX-351 (Cytarabine : Daunorubicin) Liposome Injection Versus Intensive Salvage Therapy In Adult Patients ≤ 65 Years Old With AML In First Relapse Following An Initial CR > 1 Month Duration

Phase 2
18 Years
65 Years
Not Enrolling
Acute Myeloid Leukemia

Thank you

Trial Information

Phase IIB, Multicenter, Randomized, Open-Label Trial Of CPX-351 (Cytarabine : Daunorubicin) Liposome Injection Versus Intensive Salvage Therapy In Adult Patients ≤ 65 Years Old With AML In First Relapse Following An Initial CR > 1 Month Duration

This study is a randomized, open-label, parallel-arm, fixed-dose, standard therapy
controlled Phase IIB trial. Study enrollment duration is expected to be approximately 12-18
months. On entry, patients are randomized to receive either CPX-351 or intensive first
salvage treatment.

Patients are stratified to balance the likelihood of obtaining a CR and the duration of CR
between the two arms.

Inclusion Criteria:

- Ability to understand and voluntarily sign an informed consent form

- Age ≥18 and ≤65 years at the time of relapse

- Pathological confirmation of relapsed AML after initial CR of >1 month duration

- Eastern Cooperative Oncology Group (ECOG) performance status 0- 2

- Able to adhere to the study visit schedule and other protocol requirements

- Laboratory values fulfilling the following:

- Serum creatinine < 2.0 mg/dL

- Serum total bilirubin < 2.0 mg/dL

- Serum alanine aminotransferase or aspartate aminotransferase <3xULN Note: If
elevated liver enzymes are related to disease; contact medical monitor to

- Cardiac ejection fraction > 50% by echocardiography or MUGA scan

- All men and women must agree to practice effective contraception during the study
period and for 3 months afterward if not otherwise documented to be infertile.

Exclusion Criteria:

- Patients with active second malignancies are excluded. Patients with second
malignancies in remission may be eligible if there is no clinical evidence of active
disease, documented by imaging, with tumor marker studies, etc., at screening.
Patients maintained on long-term non-chemotherapy treatment, e.g., hormonal therapy,
are eligible. In all cases, the second malignancy and its non-chemotherapy treatment
must not interfere with the investigators ability to assess the safety or efficacy of
the study treatment

- Patients with acute promyelocytic leukemia [t(15;17)]

- Total lifetime anthracycline exposure exceeding the equivalent of 368 mg/m2 of
daunorubicin (or equivalent) prior to start of study therapy

- Any serious medical condition, laboratory abnormality or psychiatric illness that
would prevent obtaining informed consent

- Administration of any antineoplastic therapy within 4 weeks of therapy; intended to
treat first relapse. In the event of rapidly proliferative disease use of
hydroxyurea is permitted until 24 hours before the start of study treatment

- Clinical evidence of active CNS leukemia

- Patients with history of and/or current evidence of myocardial impairment (e.g.
cardiomyopathy, ischemic heart disease, significant valvular dysfunction,
hypertensive heart disease, and congestive heart failure) resulting in New York Heart
Association Class III or IV staging

- Active and uncontrolled infection. Patients with a bacterial infection receiving
treatment with antibiotics may be entered into the study if they are afebrile and
hemodynamically stable for >72 hrs.

- Current evidence of invasive fungal infection (blood or tissue culture); active
hepatitis C infection or known HIV infection

- Hypersensitivity to cytarabine, daunorubicin or liposomal products

- History of Wilson's disease or other copper-related disorder

- Patients with a history of severe toxicity related to receiving conventional dose
cytarabine in first line treatment (approximately 100mg/m2/d for <7 days) are
excluded. Patients who experienced unacceptable toxicities while receiving high dose
cytarabine (approximately 3000mg/m2 for 6 doses) will not be treated again with the
same regimen, but could be randomized to treatment with conventional dose cytarabine
regimens where the risk of major toxicity is less.

- Woman who are pregnant or breast feeding

Type of Study:


Study Design:

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

Outcome Measure:

Percentage Overall Survival at 1 year

Outcome Time Frame:

Up to 1 year from randomization

Safety Issue:


Principal Investigator

Jonathan Kolitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Shore University Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

February 2009

Completion Date:

January 2012

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute
  • Myeloid
  • Leukemia
  • Adult
  • First
  • Relapse
  • AML
  • Acute Myelogenous leukemia
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Acute
  • Acute myelocytic leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



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