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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DT2219ARL | Experimental | A recombinant bispecific antibody-targeted toxin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DT2219ARL | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Serious Adverse Events | A Serious Adverse Event is defined as an adverse event that results in any of the following outcomes:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Veronika Bachanova, MD, PhD | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | DT2219ARL 60 µg/kg/Dose (Phase I) | A recombinant bispecific antibody-targeted toxin. DT2219ARL: 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. |
| FG001 | DT2219 80 µg/kg/Dose (Phase I) | A recombinant bispecific antibody-targeted toxin. DT2219ARL: 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. |
| FG002 | DT2219 60 µg/kg/Dose (Phase II) | A recombinant bispecific antibody-targeted toxin. DT2219ARL: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DT2219ARL | A recombinant bispecific antibody-targeted toxin. DT2219ARL: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| Posted | Number | events | Day 1 - Day 29 |
|
Day 50 or 30 Days after last dose
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DT2219ARL 60 µg/kg/Dose (Phase I) | A recombinant bispecific antibody-targeted toxin. DT2219ARL: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Capillary leak syndrome | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Veronika Bachanova | Masonic Cancer Center at University of Minnesota | 612-625-8287 | pham0179@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 10, 2017 | Sep 20, 2019 | Prot_SAP_000.pdf |
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| Day 29 |
| Phase II : Duration of Response | 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) | 1 year |
| Disease-free Survival | 1 year |
| Overall Survival | 1 year |
| Time to Relapse/Progression | 1 year |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | DT2219 80 µg/kg/Dose (Phase I) | A recombinant bispecific antibody-targeted toxin. DT2219ARL: 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. |
| OG002 | DT2219 (Phase II) | A recombinant bispecific antibody-targeted toxin. DT2219ARL: 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. |
|
|
|
| Primary | 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. | 12 Subjects treated on dose level 1: 4 achieved stable disease and 1 had partial response | Posted | Count of Participants | Participants | Day 29 |
|
|
|
| Secondary | Incidence of Serious Adverse Events | A Serious Adverse Event is defined as an adverse event that results in any of the following outcomes:
| Posted | Number | events | Day 29 |
|
|
|
| Secondary | Phase II : Duration of Response | 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) | Only 2 participants achieved CR or PR | Posted | Median | Full Range | days | 1 year |
|
|
|
| Secondary | Disease-free Survival | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Overall Survival | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Time to Relapse/Progression | Posted | Mean | Full Range | days | 1 year |
|
|
|
| 3 |
| 9 |
| 2 |
| 9 |
| 9 |
| 9 |
| EG001 | DT2219 80 µg/kg/Dose (Phase I) | A recombinant bispecific antibody-targeted toxin. DT2219ARL: 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. | 4 | 6 | 2 | 6 | 6 | 6 |
| EG002 | DT2219 (Phase II) | A recombinant bispecific antibody-targeted toxin. DT2219ARL: 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. | 1 | 3 | 1 | 3 | 3 | 3 |
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Lung infection | Infections and infestations | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | Systematic Assessment |
|
| Blurred vision | Eye disorders | Systematic Assessment |
|
| Capillary leak syndrome | Vascular disorders | Systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Creatinine increased | Investigations | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Edema limbs | General disorders | Systematic Assessment |
|
| Erythroderma | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypermagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypernatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| INR increased | Investigations | Systematic Assessment |
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| Lipase increased | Investigations | Systematic Assessment |
|
| Localized edema | General disorders | Systematic Assessment |
|
| Lung infection | Infections and infestations | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | Systematic Assessment |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Neutrophil count decreased | Investigations | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | Systematic Assessment |
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| Platelet count decreased | Investigations | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Spleen disorder | Blood and lymphatic system disorders | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| Weight gain | Investigations | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| White blood cell decreased | Investigations | Systematic Assessment |
|
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