Phase 2 N=18 Treatment

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

Refractory B-Lineage Leukemia · Relapsed B-Lineage Leukemia · Refractory B-Lineage Lymphoma · Relapsed B-Lineage Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT02370160 ↗

Enrolled (actual)

Serious AEs

27.8%

Results posted

Jan 2020

Primary outcome: Primary: Phase I: Incidence of Any DLT Attributed to DT2219 in the First Cycle — 1; 3; 0 events

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: DT2219ARL (Biological)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Masonic Cancer Center, University of Minnesota
Primary completion: Apr 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Phase I: Incidence of Any DLT Attributed to DT2219 in the First Cycle	1; 3; 0	—
PRIMARY Phase ll: Overall Disease Response	5	—
SECONDARY Incidence of Serious Adverse Events	2; 2; 1	—
SECONDARY Phase II : Duration of Response	59.5	—
SECONDARY Disease-free Survival	7; 5; 3	—
SECONDARY Overall Survival	3; 4; 2	—
SECONDARY Time to Relapse/Progression	27.3; 42; 30	—

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 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02370160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.