Immunotherapy for the Treatment of Acute Leukemia
Recommendations
Diagnostics prior to immunotherapy for newly diagnosed patients with 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.
Immunotherapy for the treatment of patients with ALL
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.
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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.
Immunotherapy for the treatment of patients with AML
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.
Emerging immunotherapies for the treatment of patients with acute leukemia
Role of immunotherapy post-CAR T cell therapy
With very few options available to patients who relapse after CAR T cell therapy, clinical trial enrollment should be strongly considered.
For patients with ALL who relapse or are refractory to CAR T cell therapy, a consensus could not be reached to recommend one preferred treatment. Potential options could include CAR T cell therapy targeting different antigens, blinatumomab, or allo-HCT (if eligible).
Recognition and management of immune-related AEs in patients with acute leukemia being treated with immunotherapy
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.
Patient support and quality of life (QoL) considerations
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.
Recommendation Grading
Overview
Title
Immunotherapy for the Treatment of Acute Leukemia
Authoring Organization
Society for Immunotherapy of Cancer
Publication Month/Year
October 19, 2020
Last Updated Month/Year
April 1, 2024
Supplemental Implementation Tools
Document Type
Guideline
External Publication Status
Published
Country of Publication
US
Inclusion Criteria
Female, Male, Adolescent, Adult, Child, Infant, Older adult
Health Care Settings
Ambulatory, Childcare center, Emergency care, Home health, Hospital, Long term care
Intended Users
Social worker, physician, nurse, nurse practitioner, physician assistant
Scope
Diagnosis, Treatment
Diseases/Conditions (MeSH)
D007938 - Leukemia
Keywords
chemotherapy, acute leukemia, Bone Marrow, Hematopoietic cell transplantation, novel immunotherapeutic agents, antibody-drug conjugates, bispecific T cell engagers