A multicenter Phase I/II trial investigating the safety and efficacy (CR rate and OS) of low dose AraC with Clofarabine in patients =60 years with AML not eligible for conventionalChemotherapy - Clofarabine

• Conditions: Acute myeloid leukaemia; MedDRA version: 12.1Level: PTClassification code 10000880Term: Acute myeloid leukaemia; MedDRA version: 12.1Level: LLTClassification code 10000880Term: Acute myeloid leukaemia

• Registration Number: EUCTR2009-017347-33-DE
• Lead Sponsor: niversity of Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-09
• Last Update Posted: 28 October 2013

Recruitment & Eligibility

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

Inclusion Criteria

1.Diagnosis of AML as defined by WHO
2.Primary or secondary AML
3.Age =60 years
4.Not eligible for standard/”curative” chemotherapy as described at the end of this section in refer-ence tables in section 4.3.
5.Adequate renal and hepatic functions as indicated by ALL of the following laboratory values:
a.Serum creatinine less than or equal 1.0 mg/dL (less than or equal 88,4 µmol/l) or
if serum creatinine >1.0 mg/dL (>88,4 µmol/l), then the estimated glomerular filtration rate (GFR) must be >60 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation where Predicted GFR (ml/min/1.73 m2) = 186 x (Serum Creatinine)-1.154 x (age in years)-0.023 x (0.742 if patient is female) x (1.212 if patient is black)
b.Serum bilirubin =1.5 mg/dL (17,1 µmol/l) × upper limit of normal (ULN)
c.Aspartate transaminase (AST)/ alanine transaminase (ALT) less than or equal 2.5 × ULN
d.Alkaline phosphatase less than or equal 2.5 × ULN
6.Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
7.Written informed consent (ICF)

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients meeting ANY of the following criteria will not be included in the study:
1.Diagnosis of AML M3
2.Current concomitant chemotherapy, radiation therapy, or immunotherapy other than described in section 5.2 and 5.3 of the trial protcol.
3.Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry. The patient must have recovered from all acute toxicities from any previous therapy.
4.Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment.
5.Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
6.Hypersensitivity to Clofarabine, AraC or one of their components.
7.Pregnant or nursing women.
8.Any significant concurrent disease, illness, or psychiatric disorder that would compromise pa-tient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
9.Have had a diagnosis of another malignancy, unless the patient has been disease-free for at least 3 years following the completion of curative intent therapy, with the following exceptions:
•Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed.
•Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed.
10.Psychiatric illness that would prevent granting of informed consent.
11.Active viral infection with known human immunodeficiency virus (HIV) or viral hepatitis type B or C.
12.Ongoing drug abuse.
13.Women with child bearing potency without effective contraception (i. e. implants, injectables, combined oral contraceptives, some IUDs or vasectomised partner) during the conduct of the trial. Patients using hormonal methods of contraception must be informed about possible influ-ences of the study drug on contraception.
14.Concomitant participation in other clinical trials.

Study & Design

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