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 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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38148

Enrollment

Registered

2007-08-08

Start date

2008-11-26

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute myeloid leukemia

Interventions

Remission induction course consisting of cytosine arabinoside, idarubicine and clofarabine: Arm A: Clofarabine one hour infusion Idarubicine 10 mg/m2 on days 1, 3 and 5 Cytosine arabinoside 100 mg/m

Eligibility

Age

18 Years to 99 Years

Inclusion 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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)