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

NCT02370160•Masonic Cancer Center, University of Minnesota

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Key Dates

Start Date

December 21, 2015

Primary Completion Date

April 8, 2018

Completion Date

April 8, 2018

Last Updated

January 13, 2020

Enrollment

ACTUAL participants

Conditions

Refractory B-Lineage LeukemiaRelapsed B-Lineage LeukemiaRefractory B-Lineage LymphomaRelapsed B-Lineage Lymphoma

Interventions

DT2219ARL

BIOLOGICAL