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

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10000886Term: Acute myeloid leukemia; Relapsed or refractory Acute Myeloid Leukemia (AML)

• Registration Number: EUCTR2007-005374-31-IT
• Lead Sponsor: G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL`ADULTO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-12
• Last Update Posted: 28 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the trial is to determine the complete response rate (CR/CRi) of older patients with relapsed or refractory AML when given 1 or 2 courses of low-dose Clofarabine combined with Temsirolimus.;Secondary Objective: To determine the tolerability and safety of the combination<br>To determine the duration of response<br>To determine the duration of survival;Primary end point(s): Rate of complete remission (CR+CRi)