ADCT-602 in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia

Exclusion Criteria

• •Known active central nervous system (CNS) leukemia, defined as morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF), or symptomatic CNS leukemia (i.e., cranial nerve palsies or other significant neurologic dysfunction) within 28 days prior to screening.
• •* NOTE: Patients may have a history of CNS leukemic involvement if they have received prior treatment for CNS involvement and no evidence of active disease (defined as \>= 2 consecutive spinal fluid assessments with no evidence of disease) is present at screening. Prophylactic intrathecal chemotherapy is allowed on the trial and is not a criterion for exclusion
• •Patients with Burkitt's leukemia/lymphoma
• •Active graft-versus-host disease (GVHD) or severe/extensive chronic GVHD
• •Autologous or allogenic transplant within the 60 days prior to the cycle 1 day1
• •Known history of immunogenicity or hypersensitivity to a CD22 antibody
• •Known history of positive serum human adenosine deaminase (ADA)
• •Known seropositive for human immunodeficiency (HIV), hepatitis B, or hepatitis C virus with confirmatory testing
• •History of Stevens-Johnson syndrome or toxic epidermal necrolysis syndrome
• •Pregnant or breastfeeding women
• •Significant medical comorbidities, including uncontrolled hypertension (diastolic blood pressure \> 115 mm Hg), uncontrolled atrial or ventricular cardiac arrhythmias, unstable angina, congestive heart failure (greater than New York Heart Association class II), severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia, poorly controlled diabetes, severe chronic pulmonary disease, coronary angioplasty, myocardial infarction within 6 months prior to screening
• •Use of any other experimental medication(s) within 14 days or 5 half-lives, but in no case \< 14 days prior to the start of study treatment on cycle 1, day 1
• •Major surgery, chemotherapy, systemic therapy (excluding hydroxyurea, steroids and any targeted small molecules or biologics), or radiotherapy within 14 days or 5 half-lives (whichever is shorter) prior to cycle 1, day 1 treatment
• •* NOTE: a) To reduce the circulating lymphoblast count or palliation: steroids and hydroxyurea are allowed. No washout necessary for these agents. b) Cytarabine IV could be used for cytoreduction with a washout of 1 week. c) For ALL maintenance/treatment: mercaptopurine, oral methotrexate, vincristine, and/or tyrosine kinase inhibitors. These agents should be discontinued at least 48 hours prior to start of study drugs. d) Patients may have received prior CD22-directed therapy provided the blasts remain CD22+ (\>= 20%) and \> 3 months from prior anti-CD22 exposure
• •Isolated extramedullary relapse (i.e., testicular, CNS)
• •Uncontrolled active infection
• •History of another primary invasive malignancy that has not been definitively treated or in remission for less than 2 years. Patients with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis (including concomitant diagnoses)
• •Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgment, make the patient inappropriate for study participation or put the patient at risk
• •Inability of the patient to consent themselves for this study
• •Prior history or current veno-occlusive disease (VOD)