The following patients are excluded from entering the trial (R1):
1. Infants less than a year old at diagnosis. It is recommended that these patients be entered onto the relevant Interfant ALL study.
2. Patients diagnosed with B-ALL (Burkitt-like, t(8;14), L3 morphology, SMIg positive). Patients with this disease should be treated on a suitable protocol for this condition.
3. Patients diagnosed with Philadelphia-positive ALL (t(9;22) or BCR/ABL positive). If randomised patients are subsequently found to have Philadelphia-positive ALL they will be withdrawn from UKALL 2011 protocol treatment and transferred to a suitable alternative protocol for further therapy.
4. Patients in whom written informed consent has not been obtained from parents and/or patients prior to randomisation
5. Patients who have received previous treatment for ALL or LBL except those patients who have received dexamethasone treatment for no more than 7 days (due to clinical urgency) immediately prior to randomisation.
6. Patients who are sexually active and are unwilling to use adequate contraception during therapy and for one month after last trial treatment.
4.2.2 R2 (methotrexate and pulses randomisation).
The following patients are excluded from the methotrexate and pulses randomisation:
1. MRD High Risk ALL patients as defined in section 3.4.4 and LBL patients with a poor response as defined in section 3.5. These patients are taken off protocol treatment.
2. Any patient with significant renal impairment defined as renal function outwith normal limits corrected for age, pleural effusions or ascites. It is recommended that these patients receive standard A or B (MRD Low Risk) or Capizzi (Regimen C) interim maintenance (MRD Risk or LBL); vincristine and dexamethasone pulses and intrathecal methotrexate in maintenance.
3. Previous history of methotrexate encephalopathy. It is recommended that these patients receive standard (MRD low risk) or Capizzi (Regimen C) interim maintenance (MRD risk or LBL) and vincristine and dexamethasone pulses during continuation therapy.
4. MRD Intermediate risk patients with a history of pancreatitis. These patients should not receive further asparaginase. It is recommended that these patients be allocated high dose methotrexate as interim maintenance (without asparaginase) and vincristine and dexamethasone pulses during continuation therapy.
5. Candidates for allogeneic SCT in CR 1.
6. Down's syndrome (DS) patients. See section 3.3.2 and Appendix 5 for further information about DS patients.
7. Patients who have received prior cranial irradiation.
8. Patients with M3 marrow at day 29.
Prof David Bowen
Tel 0113 2067924/ 2068481
Tel 0113 2067436
Other trials currently active for Acute Lymphoblastic Leukaemia
A randomized trial for adults with newly diagnosed acute lymphoblastic leukaemia.
For precursor-B lineage ALL, the main aim is to determine if the addition of Rituximab to standard induction chemotherapy results in improved EFS.
For T lineage ALL, the main aim is to determine if the addition of nelarabine following standard induction therapy improves outcomes.
A Phase 2 study for older adults with Acute Lymphoblastic Leukaemia