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Clinical Trials/NL-OMON38148
NL-OMON38148
Completed
Phase 2

Clofarabine in combination with a standard remission induction regimen (AraC and idarubicin) in patients 18-60 years old with previously untreated intermediate and bad risk acute myelogenous leukemia (AML) or high risk myelodysplasie (MDS): a phase I-II study of the EORTC-LG and GIMEMA (AML-14A trial) - Clofarabine in patients with untreated AML/MDS

European Organisation for Research in Treatment of Cancer (EORTC)0 sites40 target enrollmentTBD
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Conditionsacute myeloid leukemia10024324

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
acute myeloid leukemia
Sponsor
European Organisation for Research in Treatment of Cancer (EORTC)
Enrollment
40
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
European Organisation for Research in Treatment of Cancer (EORTC)

Eligibility Criteria

Inclusion Criteria

  • •Age 20 \* 60 years inclusive
  • •WHO PS grade 0 \* 2
  • •previously untreated AML according to the new WHO criteria i.e. percentage bone marrow blasts \> 20%
  • •high risk MDS \> 10% blast cells
  • •All AML FAB subtypes except M3
  • •All cytogenetic groups except those with the good risk features t(8;21\), inv(16\), and a WBC count at diagnosis of \< 100 x 109/L
  • •Written informed consent required

Exclusion Criteria

  • •Concomitant malignant disease
  • •Central nervous system leukemia
  • •Active uncontrolled infection
  • •Inadequate renal function (creatinine \> 2 mg/dl i.e. \>\= 2 x ULN) and liver function (bilirubin \> 2 mg/dl, i.e. \> 2 x ULN, ASAT/ALAT \> 5 x ULN)
  • •Concomitant severe uncontrolled cardiovascular disease i.e. symptomatic congestive heart failure or symptomatic ischemic heart disease
  • •Any psychological, familial, sociological, and geographical condition potentially hampering compliance with the study protocol and follow\-up schedule
  • •Known HIV positivity
  • •Pregnant (in case of doubt a pregnancy test is required) and breast feeding women

Outcomes

Primary Outcomes

Not specified

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