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

Recruitment & Eligibility

Status: Recruiting stopped after recruiting started

Sex: All

Target Recruitment: 13

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 <=1.0 mg/dL (<=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) <=2.5 × ULN
d.Alkaline phosphatase <=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)

Exclusion Criteria

1.Diagnosis of AML M3
2.Current concomitant chemotherapy, radiation therapy, or immunotherapy other than described in the trial protocol.
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 patient 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:
9a.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.
9b.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 influences of the study drug on contraception.
14.Concomitant participation in other clinical trials:
During the verification of the in- and exclusion criteria the trial physician checks, if the patient is participating in any other interventional clinical trials following the AMG at the same time. Should this be the case, the patient will not be included. Simultaneously the patient declares not to take part in any parallel interventional clinical trials following the AMG by signing the informed consent sheet.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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