HM2014-26 DT2219 for Relapsed or Refractory B-Lineage Leukemia or Lymphoma
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|ClinicalTrials.gov Identifier: NCT02370160|
Recruitment Status : Completed
First Posted : February 24, 2015
Results First Posted : January 13, 2020
Last Update Posted : January 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Refractory B-Lineage Leukemia Relapsed B-Lineage Leukemia Refractory B-Lineage Lymphoma Relapsed B-Lineage Lymphoma||Biological: DT2219ARL||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||HM2014-26 DT2219 Immunotoxin for the Treatment of Relapsed or Refractory CD19 (+) and/or CD 22 (+) B-lineage Leukemia or Lymphoma|
|Actual Study Start Date :||December 21, 2015|
|Actual Primary Completion Date :||April 8, 2018|
|Actual Study Completion Date :||April 8, 2018|
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.
- Phase I: Incidence of Any DLT Attributed to DT2219 in the First Cycle [ Time Frame: Day 1 - Day 29 ]
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
- Phase ll: Overall Disease Response [ Time Frame: Day 29 ]
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.
- Incidence of Serious Adverse Events [ Time Frame: Day 29 ]
A Serious Adverse Event is defined as an adverse event that results in any of the following outcomes:
- 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
- Phase II : Duration of Response [ Time Frame: 1 year ]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)
- Disease-free Survival [ Time Frame: 1 year ]
- Overall Survival [ Time Frame: 1 year ]
- Time to Relapse/Progression [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02370160
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Veronika Bachanova, MD, PhD||Masonic Cancer Center, University of Minnesota|