AMLM26 INTERCEPT: A multi-arm trial for patients with acute myeloid leukaemia investigating new treatments which target early relapse and changes in disease characteristics - The Master Protocol

Not Applicable

Recruiting

Conditions: Acute myeloid leukaemia (AML)
Cancer - Leukaemia - Acute leukaemia

Registration Number: ACTRN12621000439842

Lead Sponsor: Australasian Leukaemia & Lymphoma Group

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

for study entry:
- diagnosis of AML in first or second CR/CRi
- a diagnostic baseline bone marrow and/or blood sample suitable for DNA/RNA-based studies is available
- presence of molecular and/or flow cytometric MRD marker(s) at AML diagnosis

to commence active treatment:
- WBC <25 x 10^9/L (hydroxyurea permitted for WCC control)
- for initial therapy on trial patient must have evidence of morphologic relapse or molecular progression/relapse
- for patients on trial rotating to other therapies - must have evidence of progressive disease, treatment failure or relapse

there will be additional arm specific eligibility criteria which will be specified in the domain-specific protocols

Exclusion Criteria

for study entry:
-Acute promyelocytic leukaemia
-prior allogeneic stem cell transplantation within 3 months of post-conditioning or on greater than or equal to 10mg/day prednisolone for graft vs host disease

to commence active treatment:
- known active CNS disease
-Within 14-days from receipt of prior anti-leukaemic therapy (except hydroxyurea or 6-thioguanine)

there will be additional arm specific eligibility criteria which will be specified in the domain-specific protocols

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the response of AML patients to their first-line of targeted therapy on study. In patients with marrow blasts greater than or equal to 5% prior to the start of therapy, morphologic response (CR, CRi, CRh or MLFS).<br>In patients with rising minimal residual disease prior to the start of therapy a reduction = 1-log in the molecular marker, and/or minimal residual disease negativity, or less than 0.1% aberrant disease by flow cytometry.<br>For either stratum, the response must be achieved within 100 days of the first dose of study therapy.[ response must be achieved within 100days of the first dose of study therapy. Once treatment has commenced, response will be assessed at minimum at the end of months 1, 3, 6 and 3monthly thereafter. ]

Secondary Outcome Measures