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 enrolled 1,596 children and young people with a type of blood cancer called T-cell acute lymphoblastic leukaemia (T-ALL) and 299 with a related condition called T-cell lymphoblastic lymphoma (T-LLy). The trial was testing different combinations of chemotherapy drugs — including whether adding a drug called nelarabine, and whether one type of methotrexate dosing compared to another, made a difference to outcomes. After the initial treatment phase, participants were divided into smaller groups based on their risk level and assigned to one of four treatment arms. The reported data shows the main thing being measured was "disease-free survival" — the percentage of participants who had not experienced a relapse (cancer coming back), a new cancer, or death over the follow-up period. For the comparison of treatment arms with and without nelarabine, the reported disease-free survival figures were approximately 83% for the groups without nelarabine and 88% for the groups with nelarabine. For the comparison of methotrexate dosing types, the reported figures were approximately 91% for one methotrexate approach and 86% for the other. For the T-LLy group, disease-free survival figures of approximately 85–87% and 85–100% were reported across the two arms, depending on the subgroup. A secondary measure looked at the percentage of participants whose cancer returned in the central nervous system (brain and spinal cord); the reported data shows these figures were generally low — mostly between 0% and around 9% — varying across the different treatment arms and risk groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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 Lymphoma Trial, Completed
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 newly diagnosed with T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-NHL) at stage II, III, or IV.
- You must be enrolled in a related study called AALL08B1 before joining this trial (for T-ALL patients).
- Your diagnosis must be confirmed using specific laboratory tests that show your cancer cells have certain markers that identify them as T-cell type.
- If you have T-NHL, your diagnosis must be confirmed through appropriate laboratory testing based on the tissue samples available.
- You must not have received any prior cancer-killing chemotherapy, except for steroids and/or a specific chemotherapy called cytarabine given directly into the spinal fluid.
- If you needed steroids before starting treatment due to breathing difficulties or a very high white blood cell count, you may still be eligible, but your risk group classification may be affected.
- If you needed emergency radiation to the chest (up to a specific dose of 600 cGy) to manage airway problems, you may still be eligible.
Who may not be able to join:
- You are pregnant or currently breastfeeding.
- You have Down syndrome.
- Your lymphoma is of B-cell type rather than T-cell type (for lymphoma patients).
- Your lymphoma cannot be classified by standard methods (confirm with trial site).
- Your lymphoma shows no clear B-cell or T-cell markers on testing.
- Your cancer has spread to the fluid around the brain and spinal cord (CNS3-positive) or to the testicles (for T-NHL patients).
- You have a history of seizures and are currently taking anti-seizure medication, as this may affect your eligibility to receive one of the trial drugs called nelarabine.
- You already have moderate or severe nerve damage (such as numbness, tingling, or weakness), as this may also affect your eligibility to receive nelarabine.
- You have taken anti-seizure medication at any point in the past two years (confirm with trial site).
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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
7 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV); Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I + Arm III vs. Arm II + Arm IV); Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV); Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I + Arm II vs. Arm III + Arm IV); Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort
Can't join this trial?
Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.