HM2014-26 DT2219 for Relapsed or Refractory B-Lineage Leukemia or Lymphoma

Inclusion Criteria:

- Histologic verification of B-cell lineage leukemia or B cell non-Hodgkin lymphoma and
evidence of relapse/refractory disease with the presence of CD19 and/or CD22 by flow
cytometry or immunohistochemistry of bone marrow aspirate, peripheral blood or
node/tumor biopsy

- Relapsed refractory disease that has failed conventional therapy and other therapies
of higher priority

- Karnofsky Performance status of ≥ 60% or, if less than 16 years of age, Lansky Play
Score of ≥ 60 (appendix II)

- Recovered from effects of prior therapy

- Peripheral blast count under 50 x 109/L

- Adequate organ function within 14 days (30 days for cardiac and pulmonary) of
treatment start

- Women of childbearing potential and men should be advised and agree to practice
effective methods of contraception during the course of study

- Voluntary written consent with appropriate parent/guardian consent and minor
information sheet for participants < 18 years of age

Exclusion Criteria:

- Presence of leukemic or infectious pulmonary parenchymal disease

- Presence of active CNS leukemia

- Presence of any uncontrolled systemic infection

- Documented uncontrolled seizure disorder- a seizure disorder controlled with
medication

- Active neurologic disorder - peripheral neuropathy alone does not exclude a patient

- Active Hepatitis B or Hepatitis C (virus detectable by PCR)

- Documented penicillin or cephalosporin allergies

- Pregnant or lactating