AML16 Pilot Trial: A Phase1/2 Trial to assess the feasibility of combining Clofarabine with daunorubicin and Daunorubicin + Clofarabine with Mylotarg in older patients with Acute Myeloid Leukaemia and High Risk Myelodysplastic syndrome - AML 16 Pilot

Phase 1

Active, not recruiting

Conditions: Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome
MedDRA version: 7.1 Level: LLT Classification code 10000880

Registration Number: EUCTR2005-001588-78-GB

Lead Sponsor: Cardiff University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Patients are eligible for the AML16 Pilot trial if:

They have one of the forms of acute myeloid leukaemia as defined by the WHO Classification (Appendix A) — this can be any type of de novo or secondary AML – or high risk Myelodysplastic Syndrome, defined as greater than 10% marrow blasts (RAEB-2)

—They should normally be over the age of 60, but patients under this age are eligible if they are not considered fit for the MRC AML 15 trial.

They have a presenting white count of less than 30x109 /l

—They have given written informed consent.

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 are not eligible for the AML16 Pilot Trial if:

—They have previously received cytotoxic chemotherapy for AML. [Hydroxyurea, or similar low-dose therapy, to control the white count prior to initiation of intensive therapy is not an exclusion.]

—They are in blast transformation of chronic myeloid leukaemia (CML).

They have a concurrent active malignancy.

—They are pregnant or lactating.

—Patients have abnormal liver function tests exceeding twice the local upper limit of normal are not eligible for the Mylotarg randomisations.

—Patients who have Acute Promyelocytic Leukaemia

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the feasibility of combining Daunorubicin and Clofarabine and Daunorubicin + Clofarabine with Mylotarg in the treatment of Acute Myeloid Leukaemia and high risk Myelodyspalstic Syndrome in older (>60 years) patients;Secondary Objective: Assess Disease response;Primary end point(s): NCI Toxicity Criteria

Secondary Outcome Measures