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 AML

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002823-15-GB

Enrollment

Registered

2005-08-24

Start date

2005-10-25

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myeloid leukaemia (AML) and high risk myelodysplasia (MDS)

Interventions

Product Name: Cytarabine Pharmaceutical Form: Injection* INN or Proposed INN: Cytarabine Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20 mg in 0.2

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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). ;Secondary Objective: to determine the tocxicity of the novel combination of low dose Ara-C and Sirolimus (rapamycin). ;Primary end point(s): Disease response Duration of response Relapse rates	—

Measure

Time frame

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). ;Secondary Objective: to determine the tocxicity of the novel combination of low dose Ara-C and Sirolimus (rapamycin). ;Primary end point(s): Disease response Duration of response Relapse rates

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026