Clinical trial NCT02370160: HM2014-26 DT2219 for Relapsed or Refractory B-Lineage Leukemia or Lymphoma
Official title: HM2014-26 DT2219 Immunotoxin for the Treatment of Relapsed or Refractory CD19 (+) and/or CD 22 (+) B-lineage Leukemia or Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Refractory B-Lineage Leukemia
Relapsed B-Lineage Leukemia
Refractory B-Lineage Lymphoma
Relapsed B-Lineage Lymphoma
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2015-02-24
Enrollment: 18
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Phase I: Incidence of Any DLT Attributed to DT2219 in the First Cycle
timeFrame: Day 1 - Day 29
measure: Phase ll: Overall Disease Response
timeFrame: Day 29
Secondary outcomes:
measure: Incidence of Serious Adverse Events
timeFrame: Day 29
measure: Phase II : Duration of Response
timeFrame: 1 year
measure: Disease-free Survival
timeFrame: 1 year
measure: Overall Survival
timeFrame: 1 year
measure: Time to Relapse/Progression
timeFrame: 1 year
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Veronika Bachanova, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: