HOVON HO72

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Main info

Identificatie:
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

Scheduled
Actual
2005
28 dec.
Activated
2006
15 nov.
Closeout in Progress
2016
15 nov.
Archived

Flow

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

Site
1 results
Order by
Accrual rate
Activation date
NL-Rotterdam-ERASMUSMC
2
= Active hospitals
= Inactive hospitals

Participating Parties

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