OncoMatch/Clinical Trials/NCT04307576
A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia
Is NCT04307576 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments for leukemia, acute lymphoblastic.
Treatment: Omitted Doxorubicin · Omitted Vincristine+Dexamethasone pulses · Inotuzumab Ozogamicin+Standard Maintenance Therapy · Imatinib · 6-tioguanine+Standard Maintenance Therapy · Blinatumomab — ALLTogether collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new master protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised and interventional trials included in the study-design.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Other
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Excluded: KMT2A (MLL) rearrangement
Age < 365 days and KMT2A-rearranged (KMT2A-r) BCP-ALL (documented presence of a KMT2A-split by FISH and/or a KMT2A fusion transcript)
Excluded: BCR ABL fusion
Patients with Ph-positive ALL (documented presence of t(9;22)(q34;q11) and/or of the BCR::ABL fusion transcript)
Excluded: BCL2 rearrangement
any patients with IG::MYC and a concurrent BCL2/6 rearrangement
Excluded: BCL6 rearrangement
any patients with IG::MYC and a concurrent BCL2/6 rearrangement
Excluded: ETV6 germline mutation
germline ETV6 mutation
Allowed: MYC rearrangement
Patients with surface immunoglobulin negative (sIG-) BCP-ALL and an IG::MYC rearrangement, unless they have a concurrent BCL2/6 rearrangement. T-ALL patients with MYC translocations.
Demographics
Prior therapy
Cannot have received: systemic corticosteroids
Treatment with systemic corticosteroids corresponding to (>10mg prednisolone/m2/day) for more than one week and/or other chemotherapeutic agents in a 4-week interval prior to diagnosis (pre-treatment)
Cannot have received: chemotherapy
other chemotherapeutic agents in a 4-week interval prior to diagnosis (pre-treatment)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04307576 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Are patients with KMT2A alterations eligible?
No. KMT2A rearrangement is an exclusion criterion.
Are patients with BCR alterations eligible?
No. BCR ABL fusion is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 45 years or younger and at least 0 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages