HOVON HO67

Archived

Main info

Identifier:
HOVON 67 AML SAKK
Sponsor:
HOVON
Active sites:
9
(of 9)
Title:

Reduced intensity chemotherapy given with and without Imatinib Mesylate in patients >= 60 years considered unfit for standard chemotherapy with previously untreated Acute Myeloid Leukemia (AML) and refractory anemia with excess of Blasts (RAEB, RAEB-t).

Timeline

Scheduled
Actual
2006
23 Jan
Activated
2020
23 Oct
Archived

Flow

Flow

Details

Phase:
Prospective randomized Phase II study
Monitoring Type:
Objectives:

Eligibility

Inclusion Criteria:
  • Patients >= 60 years.
  • Patients considered unfit for standard chemotherapy.
  • Patients with a confirmed diagnosis of

a. AML FAB M0-M2 or M4�M7 (see appendix A) or
b. with refractory anemia with excess of blasts (RAEB) or refractory anemia with excess of blasts in transformation (RAEB-T) with an IPSS score > 1.5

  • Subjects with secondary AML progressing from antecedent (at least 4 months duration) myelodysplasia are also eligible.
  • AST (SGOT) and ALT (SGPT), total serum bilirubin, serum creatinine, and creatinine clearance not more than 1.5 x the upper limit of the normal range (ULN) at the laboratory where the analyses were performed.
  • Male patients agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following the discontinuation of study drug.
  • Written informed consent.
Exclusion Criteria:
  • Patients previously treated for AML (any antileukemic therapy including investigational agents)
  • Patients with cardiac dysfunction as defined by:

a. Myocardial infarction within the last 6 months prior to study entry
b. Reduced left ventricular ejection fraction of < 50% as evaluated by echocardiogram or MUGA scan
c. Unstable angina
d. Unstable cardiac arrhythmia

  • Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable
  • Patients with any serious concomitant medical condition, which could, in the opinion of the investigator, compromise participation in the study.
  • Patients who have senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.

Participating Sites

Site
9 results
Order by
Accrual rate
Activation date
NL-Amsterdam-AMC
NL-Rotterdam-EMCDANIEL
NL-Rotterdam-ERASMUSMC
NL-Den Haag-HAGA
NL-Amersfoort-MEANDERMC
NL-Enschede-MST
NL-Nieuwegein-ANTONIUS
NL-Utrecht-UMCUTRECHT
NL-Amsterdam-VUMC
= Active hospitals
= Inactive hospitals

Participating Parties

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