An open label phase II trial of Clofarabine and Temsirolimus in olderpatients with relapsed or refractory Acute Myeloid Leukemia (AML) - GIMEMA Protocol AML1107

G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL`ADULTO0 个研究点开始时间: 2009年3月12日最近更新: 2013年10月28日

适应症

试验速览

暂无简介。

•1.Cytological confirmation of AML.
•2.At least 20% of blasts in the bone marrow.
•3.AML in first relapse or refractory to no more than one prior combination chemotherapy induction regimen.
•4.Age 60 years and older.
•5.WHO PS 0-2.
•6.Adequate hepatic and renal function, unless considered due to organ leukemic involvement: .
•serum total bilirubin ≤ 1.5 x, and AST/ALT ≤ 2.5 x the institutional upper limit of normal (ULN)
•serum creatinine ≤ 1.0 mg/dL; if serum creatinine > 1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be >60 mL/min/1.73m2 as calculated by the Modification of Diet in Renal Disease (MDRD) equation [predicted GFR (mL/min/1.73m2) = 186 x (serum creatinine)-1.154 x (age in years)-0.203 x (0.742 if patient is female), x (1.210 if patient is black)]
•7.Life expectancy at least 4 weeks.
•8.More than 2 weeks from prior myelosuppressive chemotherapy. If the patient is on hydroxyurea to control peripheral blood leukemic cell counts, the patient must be off hydroxyurea for at least 48 hours before initiation of treatment on this protocol.
•9.Signed written informed consent according to IGH/EU/GCP and national laws.
•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

•1.Acute promyelocytic leukemia.
•2.Blast transformation of chronic myeloid leukemia or other myeloproliferative disorders.
•3.Prior treatment with Clofarabine or Temsirolimus.
•4.Prior allogeneic stem cell transplantation.
•5.Use of an investigational drug within 30 days of baseline visit.
•6.Active uncontrolled systemic infection.
•7.Severe concurrent medical condition or psychiatric disorder that would preclude study participation.
•8.Concurrent active malignancy.
•9.Active CNS leukemia.
•10.Positive HIV test.

发起方

G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL`ADULTO