Main info

Identifier:

HOVON 72 AML

Sponsor:

HOVON

Included patients:

2

Active sites:

1

(of 1)

Title:

Dose escalation trial of bortezomib with standard remission-induction chemotherapy in patients with relapsed acute myelocytic leukemia (AML) or refractory anemia with excess of blasts (RAEB, RAEB-t) with IPSS score >= 1.5

Timeline

Flow

Details

Phase:

Prospective Phase I/II study

Monitoring Type:

Objectives:

• Evaluation of the effect of escalated dose of bortezomib in re-induction therapy.
• Evaluation of bortezomib in combination with daunorubicin and cytarabine

Eligibility

Inclusion Criteria:

• Age 18-60 years, inclusive.
• Subjects with a cytopathologically confirmed diagnosis of AML (M0-M7, FAB classification except FAB M3 or t(15;17)), or with refractory anemia with excess of blasts (RAEB) or refractory anemia with excess of blasts in transformation (RAEB-t) with an IPSS score of >= 1.5 or patients with therapy-related AML/RAEB/RAEB-t. Also patients with biphenotypic leukemia may be included.
• Patients who have experienced a previous CR of at least 3 months duration and with a treatment free interval since last treatment of at least 3 months
• WHO performance status <= 2 (see appendix E)
• Written informed consent

Exclusion Criteria:

• Patients with primary refractory disease or who have relapsed within 3 months after obtaining a first CR
• Anti-leukemia treatment within the last 3 months
• Impaired hepatic or renal function as defined by:

a. ALT and/or AST > 3 x Upper Limit of Normal (ULN), or
b. Bilirubin > 3 x ULN, or
c. Serum creatinin > 3 x ULN (after adequate hydration), or (unless these are most likely caused by AML organ infiltration)

• Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, etcetera), or
• Cardiac dysfunction as defined by:

a. Myocardial infarction within the last 6 months of study entry, or
b. Reduced left ventricular function with an ejection fraction < 50% as measured by MUGA scan or echocardiogram (another method for measuring cardiac function is acceptable), or
c. Unstable angina, or
d. Unstable cardiac arrhythmias

• Pregnant or lactating females
• Unwillingness or not capable to use effective means of birth control

Participating Sites

= Active hospitals

= Inactive hospitals