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

HM2014-26 DT2219 Immunotoxin for the Treatment of Relapsed or Refractory CD19 (+) and/or CD 22 (+) B-lineage Leukemia or Lymphoma

This is a phase I/II study of DT2219 for the treatment of relapsed or refractory CD19 (+) and/or CD 22 (+) B-lineage leukemia and lymphoma. The study consists of two phases - a phase I dose/schedule finding component using the maximum tolerated dose identified during the previous phase I study, but with a higher number of doses and a two-stage phase II extension component to confirm safety and make a preliminary determination of the activity level by disease using the dose identified in phase I.

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 10^9/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