Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (AALL1231) enrolled 847 young people with either T-cell acute lymphoblastic leukaemia (T-ALL) — a cancer of the blood — or T-cell lymphoblastic lymphoma (T-LLy) — a related cancer of the lymph system. Participants were randomly placed into one of two treatment groups: one received a standard combination chemotherapy regimen (Arm A), and the other received the same chemotherapy plus an additional medicine called bortezomib (Arm B). The trial's main goal was to measure "event-free survival" over three years — that is, the percentage of participants who did not experience a setback such as the cancer returning, a new cancer, treatment failure, or death during treatment. The reported data shows that, looking at the primary measure across all participants, 81.7% of those in the standard chemotherapy group (Arm A) and 85.1% of those in the chemotherapy-plus-bortezomib group (Arm B) were event-free at three years. For a secondary measure comparing participants in this trial who did not receive brain radiation therapy against similar participants from an earlier trial (AALL0434) who did receive it, the three-year event-free survival figures were reported as 88.3% and 88.8% respectively. The reported data also shows that 78% of all participants experienced a side effect graded as serious (Grade 3 or higher) according to a standard medical rating scale. Among a smaller subgroup of very high-risk T-ALL patients, those whose cancer became undetectable at a microscopic level after intensive treatment blocks had a reported three-year event-free survival of 88.9%, compared with 25.0% for those in whom the cancer remained detectable. For the very high-risk T-LLy subgroup who did not respond to intensive treatment, the reported event-free survival figure was 0%. It is worth noting that the number of participants recorded as "completed" in the data is lower than those who started — the reported data does not fully explain the reasons for all participants not completing the study protocol. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 38457359) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Leukaemia Trial, Active, Not Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You must be older than 1 year and younger than 31 years of age.
- You must have been newly diagnosed with a type of blood cancer called T-cell acute lymphoblastic leukemia (T-ALL) or a related condition called T-cell lymphoblastic lymphoma (T-LLy) at stage II, III, or IV.
- If you have T-ALL, you must be enrolled in a specific related study (AALL08B1 or Project:EveryChild) before starting this trial.
- You (and/or your parent or legal guardian) must be willing and able to sign a consent form agreeing to take part.
Who may not be able to join:
- You have already received chemotherapy treatment for T-ALL, T-LLy, or any other cancer before joining this trial (with some limited exceptions — confirm with trial site).
- You received a steroid medicine called dexamethasone in the 28 days before starting the trial (except for a single dose used during a medical procedure to protect the airway).
- You already have moderate or severe nerve damage causing numbness, tingling, or weakness (confirm with trial site).
- You have a seizure disorder that is not currently under control.
- You have been diagnosed with Down syndrome (Trisomy 21).
- You are currently pregnant.
- You are breastfeeding and plan to continue doing so during the trial.
- You are sexually active and able to have children, but have not agreed to use an effective form of birth control for the entire duration of the trial.
- You have a known allergy or sensitivity to the drugs bortezomib, boron, or mannitol.
- You have a serious medical or mental health condition that may make it difficult to participate fully in the trial.
- You have taken part in another clinical trial using an experimental treatment within the past 14 days (or within 30 days of any dose of bortezomib).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: David T Teachey, Children's Oncology Group
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
8 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.