Description:
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.
Title
- Brief Title: 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
Clinical Trial IDs
- ORG STUDY ID:
2014LS093
- NCT ID:
NCT02370160
Conditions
- Refractory B-Lineage Leukemia
- Relapsed B-Lineage Leukemia
- Refractory B-Lineage Lymphoma
- Relapsed B-Lineage Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
DT2219ARL | | DT2219ARL |
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.
Trial Arms
Name | Type | Description | Interventions |
---|
DT2219ARL | Experimental | A recombinant bispecific antibody-targeted toxin. | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 12 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Phase I: Incidence of Any DLT Attributed to DT2219 in the First Cycle |
Time Frame: | Day 1 - Day 29 |
Safety Issue: | |
Description: | Dose limiting toxicity (DLT) is defined as any of the following adverse events occurring from study day 1 through 7 days after the last dose of DT2219 of the 1st treatment cycle, and not clearly attributed to the primary malignancy or intercurrent illness:
any Grade 5 adverse event
any Grade 4 neutropenia or thrombocytopenia lasting more for than 7 days
any Grade 3 thrombocytopenia with bleeding
any Grade 4 non-hematologic adverse event during DT2219 infusion
any Grade 3 non-hematologic adverse event occurring after completion of DT2219 infusion |
Secondary Outcome Measures
Measure: | Incidence of Serious Adverse Events |
Time Frame: | Day 29 |
Safety Issue: | |
Description: | A Serious Adverse Event is defined as an adverse event that results in any of the following outcomes:
Death
A life-threatening adverse event
Inpatient hospitalization or prolongation of existing hospitalization
A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
A congenital anomaly/birth defect.
Important medical event |
Measure: | Phase II : Duration of Response |
Time Frame: | 1 year |
Safety Issue: | |
Description: | Duration of response was calculated as duration between on-study date and best response date for those patients who achieved complete remission (CR) or partial response (PR) |
Measure: | Disease-free Survival |
Time Frame: | 1 year |
Safety Issue: | |
Description: | |
Measure: | Overall Survival |
Time Frame: | 1 year |
Safety Issue: | |
Description: | |
Measure: | Time to Relapse/Progression |
Time Frame: | 1 year |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Masonic Cancer Center, University of Minnesota |
Last Updated
January 13, 2020