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)

Phase 2

Completed

Conditions: acute myeloid leukemia
10024324

Registration Number: NL-OMON38148

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Phase I study:<br /><br>Safety and tolerability of clofarabine in combination with standard remission<br /><br>induction treatment for AML/MDS in order to determine the optimal dose for<br /><br>administration in the phase II trial<br /><br>Phase II;<br /><br>The efficacy (complete remission rate) after the remission induction course.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Phase I:<br /><br>Efficacy (complete remission rate) after one or two remission induction courses<br /><br>and after the consolidation course, and hematopoietic recovery after the<br /><br>remission induction and after the consolidation course.<br /><br>Phase II:<br /><br>Safety/tolerability and activity expressed as complete remission rate after the<br /><br>consolidation course, hematopoietic recovery after the induction and<br /><br>consolidation courses, feasibility of the CD34+ cells harvest after the<br /><br>consolidation course. Diseasefree survival and survival after achievement of a<br /><br>complete remission, and overall survival.</p><br>