A PHASE I/II TRIAL OF THE USE OF SIROLIMUS (RAPAMUNE) AND LOW DOSE ARA-C IN OLDER PATIENTS WITH ACUTE MYELOID LEUKAEMIA (AML) - Ara-C and Sirolimus in AM

Phase 1

• Conditions: Acute myeloid leukaemia (AML) and high risk myelodysplasia (MDS)

• Registration Number: EUCTR2005-002823-15-GB
• Lead Sponsor: ottingham University Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-24
• Study Completion: 2009-09-21
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

•All patients must be over the age of 60 years and have AML as defined by the WHO classification or MDS with a blast count of >10% according to WHO criteria (2000):

- Patients who are clinically ineligible for induction chemotherapy

- Patients with AML that has failed to remit with low dose Ara-C-based regimens or with intensive therapy

- Patients with relapsed AML following conventional intensive chemotherapy or low dose Ara-C-based regimens

•Patients must have a life expectancy of greater than 2 months

•Patients must have understood and voluntarily signed the approved informed consent form

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 with acute promyelocytic leukaemia (FAB M3)

• Patients in blast transformation of chronic myeloid leukaemia

• Patients with concurrent active malignancy

• Patients who have received a non-licenced drug within 1 month of entering the trial

• ECOG performance score of 4

• Severe hepatic impairment: Childs-Pugh score C

• Patients already known to be HIV positive

• Patients who have had a previous bone marrow or stem cell transplant

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: This trial is open to patients with AML as defined by the WHO criteria and high risk myelodysplasia (MDS, defined as >10%blasts) who are over the age of 60 years. The primary objective is to determine the response rate of these patients to the novel combination of low dose Ara-C and Sirolimus (rapamycin).<br><br>;Secondary Objective: to determine the tocxicity of the novel combination of low dose Ara-C and Sirolimus (rapamycin).<br><br>;Primary end point(s): Disease response <br>Duration of response <br>Relapse rates <br>