Leukemia — Acute Lymphoblastic (ALL) Clinical Trials

About Leukemia — Acute Lymphoblastic (ALL) trials

Lineage (B-cell vs T-cell), age, and specific molecular abnormalities together drive ALL trial selection. The Philadelphia chromosome (BCR-ABL1 fusion, the t(9;22) translocation) defines Ph+ ALL, which represents about 25% of adult ALL and gates eligibility for TKI-based trials and TKI + immunotherapy combinations. BCR-ABL1 fusion testing evaluates both partner genes and is the primary lab assay for Ph status. KMT2A (MLL) rearrangements identify a high-risk subgroup that is now actionable through menin inhibitor trials. IKZF1 deletions are common in Ph+ ALL and Ph-like ALL and inform prognosis and stratification. TP53 mutations carry adverse prognosis. FLT3 mutations are rare in ALL but actionable when present. CD19 and CD22 are surface markers central to immunotherapy: CD19 is the target for CAR-T cell therapy and blinatumomab (a CD3 / CD19 bispecific antibody), and CD22 is the target for inotuzumab ozogamicin (a CD22 ADC).

The ALL trial set divides by age, lineage, and treatment line. Pediatric and adolescent / young adult (AYA) trials run primarily through the Children's Oncology Group (COG) and similar cooperative networks, with very high cure rates that the trials are designed to maintain or modestly extend (BFM-backbone variations, MRD-guided strategies, novel agent additions). Adult B-ALL trials test new chemo backbones and increasingly chemo-light regimens centered on blinatumomab and inotuzumab. Ph+ ALL trials test TKI generation effects (third-generation TKIs vs second-generation), TKI + blinatumomab combinations as chemo-replacement strategies, and post-TKI strategies. T-ALL trials are a smaller and less-developed trial space, with novel agents in the BCL-2 inhibitor and CD7-targeted spaces. R/R B-ALL trials test CAR-T cell therapy (with age cutoffs that vary by product), CD19 / CD3 bispecifics, CD22 ADCs, and combinations. KMT2A-rearranged trials test menin inhibitors. Pre-allogeneic transplant MRD clearance trials test strategies for achieving MRD-negative status before stem cell transplant.

ALL trial eligibility centers on lineage, Ph status, age, and prior CD19 / CD22 targeted therapy exposure. Lineage confirmation (B-cell vs T-cell) is foundational because most trials are lineage-restricted. Ph status (BCR-ABL1 by RT-PCR or FISH) determines whether TKI-based trials apply. Age: many CAR-T and pediatric-cooperative trials have specific upper or lower age cutoffs (one major B-ALL CAR-T product is approved up to age 25). Prior CD19-targeted therapy (blinatumomab or CAR-T) is a defining filter for second-line and later trials. Prior CD22 ADC (inotuzumab) exposure similarly matters. Prior TKI exposure for Ph+ ALL (and which generation). MRD status (positive vs negative) for MRD-guided trials. Prior allogeneic stem cell transplant for post-transplant trials. Performance status (ECOG 0-2 typical for adults; Karnofsky or Lansky for pediatric trials). CNS involvement, where prior CNS-positive disease and current CNS status matter for many trials.

Biomarkers tested in Leukemia — Acute Lymphoblastic (ALL) trials

These are the molecular markers most commonly required or evaluated in Leukemia — Acute Lymphoblastic (ALL) eligibility criteria. OncoMatch extracts them from each trial's protocol and matches them against your test results.