Clinical Trial Information
Protocol: Alliance – A041703
Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.
Pre-registration Eligibility Criteria (Step 0)
- Submission of bone marrow aspirate and peripheral blood for MRD analysis is mandatory prior to registration; the bone marrow sample should be from the first aspiration (i.e. first pull). Aspirate needle should be redirected if needed to get first pull bone marrow aspirate. It should be initiated as soon as possible after pre-registration. • Lumbar Puncture (Spinal Tap) and Intrathecal Methotrexate:
o Patients may receive the Day 1 of Course IA dose of intrathecal (IT) methotrexate during the prior-to-registration lumbar puncture (or the venous line placement) to avoid a second lumbar puncture. If the dose is administered prior to registration, then systemic chemotherapy must begin within 7 days of this IT chemotherapy.
Registration Eligibility Criteria (Step 1)
- Morphologic diagnosis of precursor B-cell acute lymphoblastic leukemia (ALL) based on WHO criteria. Patients with Burkitt lymphoma/leukemia are not eligible.
CD22-positive disease defined as CD22 expression by ≥ 20% of lymphoblasts by local hematopathology evaluation.
Philadelphia chromosome/BCR-ABL1-negative ALL by cytogenetics, FISH, and/or PCR. If any test is positive for Philadelphia chromosome/BCR-ABL1, then the patient is ineligible.
No active central nervous system (CNS) leukemia (i.e. only CNS-1 disease allowed). Active CNS leukemia is defined as morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF), use of CNS-directed local treatment for active disease within 28 days prior to registration, symptomatic CNS leukemia (i.e. cranial nerve palsies or other significant neurological dysfunction) within the 28 days prior to registration, and/or known asymptomatic parenchymal CNS mass lesions; see below for additional guidance. Prophylactic intrathecal medication alone is not an exclusion.
• Categories of CNS Involvement for CNS Evaluation Prior to Registration:
o CNS 1: CSF has < 5 WBC/μL with cytospin negative for blasts; or ≥ 10 RBC/μL with cytospin negative for blasts.
o CNS 2: CSF has < 5 WBC/μL with cytospin positive for blasts; or ≥ 10 RBC/μL with cytospin positive for blasts; or ≥ 10 RBC /μL, WBC/μL ≥ 5 but less than Steinherz/Bleyer algorithm with cytospin positive for blasts (see below).
o CNS 3: CSF has ≥ 5 WBC/μL with cytospin positive for blasts; or ≥ 10 RBC/μL, ≥ 5 WBC/μL and positive by Steinherz/Bleyer algorithm (see below); or clinical signs of CNS leukemia (such as facial nerve palsy, brain/eye involvement or hypothalamic syndrome).
Steinherz/Bleyer Method of Evaluating Initial Traumatic Lumbar Punctures:
▪ If the patient has leukemia cells in the peripheral blood and the lumbar puncture is traumatic and contains ≥ 5 WBC/μL with blasts, the following algorithm should be used to define CNS disease:
CSF WBC/CSF RBC > 2 x (Blood WBC/Blood RBC count)
Patients with known or suspected testicular involvement by leukemia are allowed provided that the patient receives concomitant scrotal/testicular radiotherapy.
• Unilateral or bilateral testicular enlargement should be assessed by ultrasound or other imaging technique. Biopsy is recommended if clinical findings are equivocal or suggestive of hydrocele or a non-leukemic mass, but further assessments are per treating physician discretion.
2. ECOG Performance Status: 0-2