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 myelodysplasia (MDS): a phase I-II study of the EORTC-LG and GIMEMA (AML-14A trial). - AML-14A

Phase 1

• Conditions: Previously untreated intermediate and bad risk acute myelogenous leukemia (AML) or high risk myelodysplasia (MDS); MedDRA version: 14.1Level: LLTClassification code 10028532Term: MyelodysplasiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2006-004912-28-BE
• Lead Sponsor: European Organisation for Research and Treatment on Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-03
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age 18 – 60 years (including 60)
• AML according to the new WHO criteria i.e. percentage bone marrow (BM) blasts = 20%, or MDS with = 10% blast cells in the BM
• All AML FAB subtypes except M3
• All cytogenetic groups except:
- those with t(15;17)
- those with t(8;21) or inv(16), and a WBC count at diagnosis of < 100 x109/l
• Primary and secondary AML (including AML after MDS)
• Previously untreated, except for = 14 days of hydroxyurea
• WHO PS grade 0 – 2
• Adequate renal and hepatic function tests as indicated by the following laboratory values:
- serum creatinine = 1.0 mg/dl(= 88.7micromol/L); if serum creatinine > 1.0 mg/dl (> 88.7micromol/L) then the glomerular filtration rate (GFR) must be > 60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation where the predicted GFR (ml/min/1.73 m2 ) = 186x(serum creatinine in mg/dl)-1.154 x (age in years)-0.203 x (0.742 if patient is female) x (1.212 if patient is black).
NOTE: if serum creatinine is measured in micromol/L recalculate it in mg/dl according to the equation: 1 mg/dl=88.7micromol/L and used above mentioned formula
- Aspartate Transaminase(AST)/Alanine transaminase(ALT) = 2.5 x ULN and alkaline phosphatase = 2.5 x ULN .
• Potential fertile patients agree to use an effective barrier method of birth control during study treatment and for at least 3 months after end of study treatment.
• Before patient registration/randomization, written informed consent must be given according to ICH/EU GCP, and national/local regulations
• Patient can only be registered once in this Phase I/ Phase II trial
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Blast crisis of chronic myeloid leukemia or AML supervening a myeloproliferative disorder
• Central nervous system leukemia
• Concomitant malignant disease
• Active uncontrolled infection
• Concomitant severe uncontrolled cardiovascular disease i.e. symptomatic congestive heart failure or symptomatic ischemic heart disease (NYHA grade III-IV).
• Any psychological, familial, sociological, and geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
• Known HIV positivity
• Pregnancy (in case of doubt a pregnancy test is required) and breast feeding women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified