ALL06 A Phase II trial of an intensive pediatric protocol incorporating post-induction stratification based on minimal residual disease levels for the treatment of adolescents aged 15 years and above, and young adults aged up to 40 years, with newly diagnosed acute lymphoblastic leukaemia (ALL)

Australasian Leukaemia and Lymphoma Group (ALLG)

Dataset description

Dataset includes: Data for 86 patients aged 15-40 years with newly diagnosed Acute Lymphoblastic Leukaemia. Modified form of BRM-2000 protocol in the 15-40 age group. Complete remission, disease-free survival and overall survival. Toxicity
Click to explore relationships graph

Source Study


Other Collaborative groups,Australasian Leukaemia and Lymphoma Group

Scientific enquiries

Dr Dr Matthew Greenwood

Brief Summary

This study will be a national clinical trial that will evaluate the safety and efficacy of a chemotherapy treatment, administered to adolescents and young adults with a newly diagnosed bone marrow cancer, called acute lymphoblastic leukaemia (ALL). Who is it for? You may be able to join this study if you are aged between 15 to 40 years and have been recently diagnosed with acute lymphoblastic leukaemia (ALL), for which you have not yet undergone any treatment. Trial details: ALL is the most comm ....
Read more

Key Inclusion Criteria

All of the following criteria must be satisfied for registration on the study. 1. A morphological diagnosis of ALL byWHO criteria, confirmed by immunophenotyping and cytogenetics. All clinico-pathological subtypes will be eligible, except for mature B or Burkitt ALL (L3). 2. Has provided written, informed consent 3. Available for follow up for at least 3 years 4. Males capable of parenting a child and women of childbearing potential must be using a medically acceptable and adequate method of con ....
Read more

Key Exclusion Criteria

Presence of any of the following criteria will exclude the subject from registration on the study. 1. Subjects aged less than 15 or more than 40 years at Screening 2. Patients known to have Philadelphia chromosome-positive disease 3. Presence of serious cardiac, pulmonary, hepatic or renal disease. 4. Previous treatment for ALL or history of cancer (other than basal cell skin cancer or carcinoma of the cervix in situ, or other localised cancer treated by surgical excision only more than 5 years ....
Read more

Can healthy volunteers participate?




Sample Size    86

Min. age    15 Years

Max. age    40 Years

Sex    Both males and females

Condition category    Untreated ALL aged 15 to 40 years

Condition code    Cancer


Intervention code Treatment: Drugs

All patients will commence treatment with Protocol I which is an intensive chemotherapy induction protocol. Various prognostic factors such as cytogenetic abnormalities, initial response to prednisolone, achievement of remission, and MRD levels after induction and consolidation, will determine whether patients continue treatment outlined in Protocol M, or are to be treated on the High Risk protocol, or undergo allogeneic Haemopoietic Cell Transplantation (HCT). Patients removed for allogeneic HC ....
Read more


Control group Historical

Paediatric patients diagnosed with the same condition who were treated as part of a different ALLG study (ANZCHOG study 8, ANZCTR registration number ACTRN12607000302459)


Outcome: The primary objective of this study is to determine whether a modified form of the BFM-2000 protocol can be administered to patients with newly diagnosed and untreated ALL aged between 15 and 40 years in a comparable timeframe to patients under 15 years of age. All patients will commence treatment with Protocol 1, which is an intensive chemotherapy induction protocol. Various prognostic factors such as cytogenetic abnormalities, initial response to prednisolone, achiev ....
Read more

Study Protocol: Study protocol
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?


What data in particular will be shared?

De-identified IPD data, for all data collected during the trial

When will data be available?

Data available 3 months following publication, for an indefinite period

Available to whom?

Data are potentially available to: • Researchers from not-for-profit organisations • Commercial organisations • Other Based in: • Any location Further information: All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.

Available for what types of analyses?

Any type of analysis Assessed on a case-by-case basis

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see