A Phase III Randomized Study of CLORETAZINE™ (VNP40101M) and Cytosine Arabinoside (AraC) in Patients with Acute Myeloid Leukemia in First Relapse

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 420

Inclusion Criteria

A.Patients must have AML (any WHO classification excluding acute promyelocytic leukemia) in first relapse after a first CR (or CRp) . Bone marrow aspirates and/or biopsies must contain = 10% blasts. The duration of first CR (or CRp) must have been at least 3 months but less than 24 months, calculated from the day CR was documented following the initial induction regimen to the day leukemia relapse was confirmed by recurrence of blasts in peripheral blood, bone marrow histopathology and/or histological proven CNS or extramedullary disease.
B.There is no restriction on number of regimens or type of treatment required to induce first CR (or CRp) or number of regimens or type of treatment administered for consolidation in first CR (or CRp).
C.Patients cannot have received any treatment other than hydroxyurea in first relapse. Hydroxyurea should be discontinued at least 12 hours prior to initiation of protocol treatment.
D.Age = 18.
E.ECOG performance status of 0-2.
F.Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device (IUD), oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this trial. Nursing patients are excluded. Sexually active men must also use acceptable contraceptive methods. Pregnant and nursing patients are excluded because the effects of CLORETAZINE™ on a fetus or nursing child are unknown.
G.Must be able and willing to give written informed consent and comply with requirements of the protocol.
H.Patients must have the following clinical laboratory values:
1.Serum creatinine £ 2.0 mg/dl.
2.Total bilirubin £ 1.5x the upper limit of normal.
3.Aspartate aminotransferase (AST, SGOT) £ 3x the upper limit of normal.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A.Uncontrolled active infection of any kind. Patients with infections that are under active treatment with antibiotics and whose infections are controlled may be entered to the study. Patients with chronic hepatitis are eligible.
B.No current evidence of invasive fungal infection (blood cultures or tissues cultures). C.Myocardial infarction within previous 3 months, arrhythmias not controlled by medication, or uncontrolled congestive heart failure.
D.Patients receiving any other standard or investigational treatment for their leukemia.
E.Clinical evidence by tumor marker, pathology, or radiologic studies of an active second malignancy.
F.Presence of any other severe medical condition that may compromise the safety of treatment, for example, severe chronic obstructive pulmonary disease, or requirement for supplemental oxygen at rest.
G.Because the CLORETAZINE™ formulation contains 30% ethanol, patients being treated with disulfiram (Antabuse) are excluded from the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine if the regimen of CLORETAZINE™ and araC increases rate of CR/CRp compared to placebo and araC in AML patients in first relapse.;Secondary Objective: To compare CLORETAZINE™/araC versus placebo/araC with regard to the following: <br>-Time-to-progression or death from any cause<br>- Duration of response<br>- Survival<br>- Toxicity;Primary end point(s): Overall response rate

Secondary Outcome Measures

Name	Time	Method

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