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

niversität Leipzig0 sites13 target enrollmentOctober 7, 2010

ConditionsMedDRA - 10000886, akute myeloische Leukämie, acute myeloid leukemia C92.0 Acute myeloblastic leukaemia [AML]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: MedDRA - 10000886, akute myeloische Leukämie, acute myeloid leukemia
Sponsor: niversität Leipzig
Enrollment: 13
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 7, 2010

End Date

August 25, 2013

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

niversität Leipzig

Eligibility Criteria

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

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.