InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.
Learn why

Optimise reading forHealth ProfessionalsPatients

RecruitingLast updated: 18 April 2024

AMLM26 INTERCEPT: This is the master protocol for the INTERCEPT study, which is a multi-arm treatment trial for people with acute myeloid leukaemiaAMLM26- INTERCEPT (Investigating Novel Therapy to Target Early Relapse and Clonal Evolution as Pre-emptive Therapy in AML): A Multi-arm, Precision-based, Recursive, Platform Trial - The Master Protocol

Clinical summary

Summary

Participants enter the study in first or second morphologic remission (CR or CRi) with known and trackable MRD marker(s). The relevant MRD marker(s) will be monitored as per standard practice until evidence of MRD failure and/or morphological relapse. Participants will then be allocated to the best available treatment option at the time. If there is more than one treatment option of equal value for the participant, they will be randomised to one option. As this is a platform trial, new treatment arms may be added and others may be removed if ineffective. New targeted treatment domains may be created when there is sufficient evidence available to enable biomarker-driven enrichment cohorts to be accrued to more rapidly. In domains with a single treatment arm, proof of concept analyses of the primary efficacy endpoint will commence after the first 10 patients have had the required assessments or withdrawn earlier. In domains with more than one treatment arm and with a pre-planned comparison of the arms, the timing of the first analysis will be determined when these arms are added to the trial and information included in the specific treatment arm's linked ANZCTR entry.

Conditions

This trial is treating patients with acute myeloid leukaemia

Cancer

Blood Cancers Haematological

Age

People18+

Phase

Not applicable

Trial Acronym

AMLM26 INTERCEPT

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Australasian Leukaemia and Lymphoma Group (ALLG)

Scientific Title

AMLM26- INTERCEPT (Investigating Novel Therapy to Target Early Relapse and Clonal Evolution as Pre-emptive Therapy in AML): A Multi-arm, Precision-based, Recursive, Platform Trial - The Master Protocol

Eligibility

Inclusion

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

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

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

Recruiting hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Cancer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.