AMLM26 INTERCEPT MRD
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
Acute Myeloid Leukaemia
The aim is to demonstrate that targeting rising minimal residual disease (MRD) in patients with progressive acute myeloid leukemia (AML) may be an effective approach to maintaining patients in remission for longer. The trial will also determine if a range of novel treatments aimed at targeting MRD will result in improved treatment outcomes.
You may be eligible to participate in this study if you are an adult with acute myeloid leukemia and are currently in your first or second morphologic remission with a known and trackable MRD marker.
If you enter the trial your MRD marker(s) will be monitored as per standard practice until evidence of MRD progresssion and/or morphological relapse. When this occurs you will then be allocated to the best available treatment option for your MRD markers. This is determined by a set of clinical decision rules upon discussion with a MRD committee (a group of specialist doctors in AML), If there is no preference for a specific treatment for you, you may be randomly allocated to one.
Once on treatment you will be continue to have your MRD monitored, if you do not respond to treatment or your disease worsens you may be removed from treatment and be reassessed for the next best treatment option for you to receive (either on or off trial). During treatment you will be assessed regularly which will include physical exams, blood tests, ECG (test on your heart), bone marrow biopsies, toxicities to the treatment, quality of life. If responding to the treatment you will continue on treatment for 12months. After treatment your disease will continue to be monitored and if you have MRD progression or morphological relapse you will be assessed for the next best treatment option for you.
It is hoped that the results of this trial will help us understand the natural history of MRD markers in patients during the course of their disease through diagnosis, treatment and relapse as well as making new treatments available to patients with AML at a faster rate using the platform trial design (many treatments teste through one trial) than with current clinical trial practices.
Key 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
Key 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 diseaseto commence active treatment:
– known active CNS disease
-Within 14-days from receipt of prior anti-leukaemic therapy (except hydroxyurea or 6-thioguanine)
-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 diseaseto 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
Dr. Carolyn Grove
Australasian Leukaemia & Lymphoma Group
Phase 1 / Phase 2
AMLM26 – INTERCEPT
ACTRN12621000439842