Minneapolis, Minnesota 55455


Purpose:

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.


Criteria:

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


NCT ID:

NCT02370160


Primary Contact:

Principal Investigator
Veronika Bachanova, MD, PhD
Masonic Cancer Center, University of Minnesota

Timothy Krepski, RN
Phone: 612-273-2800
Email: tkrepsk1@fairview.org


Backup Contact:

N/A


Location Contact:

Minneapolis, Minnesota 55455
United States

Timothy Krepski
Phone: 612-273-2800
Email: tkrepsk1@fairview.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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