HM2014-26 DT2219 Immunotoxin for the Treatment of Relapsed or Refractory CD19 (+) and/or CD 22 (+) B-lineage Leukemia or Lymphoma
Sponsor study identifier
interventional
18
1 country
1
Study Start
December 21, 2015
Actual (reported)Primary Completion
April 8, 2018
Actual (reported)Study Completion
April 8, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 8, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 18, 2015
Actual (reported)February 24, 2015
Actual (reported)December 21, 2015
Actual (reported)April 8, 2018
Actual (reported)April 8, 2018
Actual (reported)January 13, 2020
Actual (reported)Phase I: Incidence of Any DLT Attributed to DT2219 in the First Cycle
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
Day 1 - Day 29
Phase ll: Overall Disease Response
Response is defined as complete response, partial response and stable disease. Complete response is defined as the disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Partial response is defined as a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. Stable disease is defined as cancer that is neither decreasing nor increasing in extent or severity.
Day 29
Incidence of Serious Adverse Events
Day 29
Phase II : Duration of Response
1 year
Disease-free Survival
1 year
Overall Survival
1 year
Time to Relapse/Progression
1 year
A recombinant bispecific antibody-targeted toxin.
DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455, United States
Veronika Bachanova, MD, PhD
Masonic Cancer Center, University of Minnesota
18 participants (actual enrollment reported by the registry).
First Submitted
February 18, 2015
First Posted
February 24, 2015
Study Start
December 21, 2015
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
April 8, 2018
Actual (reported)Study Completion
April 8, 2018
Actual (reported)Last Updated
January 13, 2020
Results First Posted
January 13, 2020
Record last verified: 2019-12
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Source: ClinicalTrials.gov.
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