ALLG ALL06
ACTRN12611000814976
Treatment
Phase 2
Other Collaborative groups,Australasian Leukaemia and Lymphoma Group
Dr Dr Matthew Greenwood
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
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
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
No
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
yes
De-identified IPD data, for all data collected during the trial
Data available 3 months following publication, for an indefinite period
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.
Any type of analysis Assessed on a case-by-case basis