Immunotherapy for the Treatment of Acute Leukemia

Cell markers at diagnosis and at the time of disease relapse should be performed to identify potential markers that drugs can be used for treatment.

Upfront diagnostics for AML should include the cell markers CD33 and CD123.

CD19+ ALL patients may be eligible for blinatumomab or tisagenlecleucel (patients aged ≤25 years).

CD22+ ALL patients may be eligible for inotuzumab ozogamicin.

CD33+ AML patients may be eligible for GO.

While a number of immunotherapies do have a role in the treatment of patients with acute leukemia in various settings, clinical trial enrollment should be considered at each juncture.

New, experimental drugs should be administered at centers that have proper support, infrastructure, and subspecialties.

Patients with relapsed B-ALL should receive immunotherapy as a bridging therapy to induce remission prior to allo-HCT.

Options for patients with relapsed ALL after one line of prior therapy include clinical trial enrollment, treatment with blinatumomab or inotuzumab ozogamicin, or allo-HCT.

For patients with relapsed B-ALL and a high disease burden, inotuzumab ozogamicin should be considered first followed by blinatumomab for persistent disease or MRD positivity, based on the clinical experience and consensus of the Expert Panel.

Because inotuzumab ozogamicin increases the risk of SOS/VOD in subsequent transplants, the number of cycles should be limited if allo-HCT is planned.

Patients with newly diagnosed B-ALL who are MRD positive after undergoing induction chemotherapy should be offered blinatumomab.

• CAR T cell therapy is strongly recommended for patients with relapsed ALL after second-line and/or third-line therapy.

Outcomes for MRD‐positive patients are generally poor; therefore, enrollment into a clinical trial should be considered to help achieve an MRD‐negative status.

While many immunotherapy approaches may have a role in the treatment of patients with AML in various settings, clinical trial enrollment should be considered at each juncture.

Outcomes are generally worse after allo-HCT for patients who achieve morphological remission after induction chemotherapy, yet display persistent MRD. Further studies are needed to identify therapeutic options for these patients. Therefore, enrollment into a clinical trial should be considered to help achieve an MRD‐negative status.

The use of rituximab in patients with CD20+ B-ALL is recommended.

For patients participating in clinical trials using CAR T cells, toxicity should be assessed and managed as per study protocols.

Patients treated with CAR T cells or blinatumomab should be monitored vigilantly for signs of CRS and neurotoxicity including (but not limited to) fever, hypotension, and altered mental state.

The management of CRS or neurotoxicity secondary to approved CAR T cell therapy or blinatumomab should follow established guidelines.

Prior to being treated with immunotherapy, patients and caregivers should be educated about potential AEs and given clear instructions for call parameters for any toxicities.

Study protocols for new, investigational agents should incorporate QoL assessment using validated tools.