Acute lymphoblastic leukemia is a cancer of white blood cells that progresses rapidly without treatment. It's the most common childhood cancer, though it also occurs in adults. Chemotherapy cures about 90% of children with ALL, but adult survival rates are lower and relapse remains a major challenge.
What's actually going on in research
Trials are testing CAR T-cell therapy for relapsed disease, targeted drugs like inotuzumab ozogamicin and blinatumomab that direct immune cells to kill leukemia, and combinations that add targeted agents to standard chemotherapy. Researchers are also studying how to predict which patients need more intensive treatment and which can safely receive less chemotherapy.
CAR T-cell therapy
This approach engineers a patient's own immune cells to hunt down leukemia cells. Tisagenlecleucel was FDA-approved in 2017 for children and young adults whose ALL returns after treatment.
Targeted antibodies
Drugs like blinatumomab link immune cells directly to leukemia cells, helping the body destroy cancer. Studies are testing whether adding these to initial chemotherapy prevents relapse.
Risk-adapted treatment
Genetic testing of leukemia cells now guides how much treatment someone receives. Trials are exploring whether children with favorable genetics can receive less chemotherapy while maintaining cure rates.
What to know before you search
Eligibility depends on whether ALL is newly diagnosed or relapsed, genetic features of the leukemia cells, age, prior treatments, and fitness for intensive chemotherapy or transplant.
What types of trials are currently open
- Frontline treatment trials — Testing new drug combinations for newly diagnosed ALL, often adding targeted therapies to standard chemotherapy to improve cure rates.
- Relapsed disease trials — Testing CAR T-cell therapy, new antibody drugs, and chemotherapy combinations for ALL that returns after initial treatment.
- Maintenance trials — Studying whether new drugs during the maintenance phase can prevent relapse while reducing side effects.
- Minimal residual disease trials — Testing treatments guided by ultra-sensitive tests that detect tiny amounts of remaining leukemia cells.
- Transplant trials — Comparing stem cell transplant to chemotherapy alone, and testing ways to reduce transplant complications.
Recently added Acute Lymphoblastic Leukemia trials
Asciminib and Inotuzumab Ozogamicin for Relapsed or Refractory Philadelphia Chromosome-positive B-cell Acute Lymphoblastic Leukemia (R/R Ph+ B-ALL)
This is a multi-center phase 1 open-label study to determine the safety of ABL001 and INO in patients with relapsed or refractory Philadelphia chromosome-positive b-cell acute lymphoblastic leukemia.
CD19 Sequential CD22 In Vivo CAR-T Cell Immunotherapy for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
This is a single-center, open-label, single-arm, prospective, investigator-initiated dose-escalation study to evaluate the safety, tolerability, preliminary efficacy, and cellular kinetics of an in vivo CAR-T cell immunotherapy targeting CD19 sequentially followed by CD22, in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). The investigational product is a targeted lentiviral vector that transduces the patient's endogenous T/NK cells in situ; no leukapheresis, ex vivo manufacturing, or lymphodepleting conditioning is required. Participants receive an intravenous infusion of CD19-targeted in vivo CAR-T on Day 0, followed by an intravenous infusion of CD22-targeted in vivo CAR-T on Day 7. Before the Day 7 infusion, the investigator will assess each participant to determine whether the second infusion should proceed, based on: (i) the proportion of CAR-positive T/NK cells in peripheral blood, which reflects the success of in vivo transduction and early expansion after the first infusion; (ii) the maximum grade and current control of adverse events occurring after the first infusion, including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS); and (iii) the participant's general condition, including Eastern Cooperative Oncology Group (ECOG) performance status and vital organ function (cardiac, hepatic, renal, pulmonary, and coagulation). The second infusion will be postponed or cancelled if any of these assessments indicates that the risk outweighs the benefit, for example grade \>=3 CRS or grade \>=2 ICANS that has not resolved to grade \<=1, or investigator-judged deterioration in organ function. Dose escalation follows a traditional 3+3 design with planned dose levels of 1×10\^9, 3×10\^9, and 6×10\^9 transducing units (TU), guided by dose-limiting toxicities (DLTs) assessed during Days 0-28; higher dose levels may be explored if the maximum tolerated dose is not reached. Treatment-emergent adverse events and serious adverse events, including CRS, immune effector cell-associated neurotoxicity syndrome (ICANS), hematologic toxicity, and organ toxicity, will be assessed. Preliminary antitumor activity will be evaluated by objective response rate (ORR), overall survival (OS), and progression-free survival (PFS), and the expansion and persistence of in vivo-generated CAR-T cells in peripheral blood will also be evaluated.
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