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| ID | Type | Description | Link |
|---|---|---|---|
| IRB202003214 | Other Identifier | University of Florida | |
| OCR40160 | Other Identifier | University of Florida |
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PI decision to close study early due to limited data due to accrual goal not being met
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This phase 2, open label, non-randomized study will evaluate the safety of administering high dose cytarabine (HiDAC) consolidation therapy on days 1-3 of each cycle, as compared to standard administration on days 1, 3, and 5 of each cycle, in patients 61 years and older with de novo acute myeloid leukemia (AML).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective HiDAC Treatment (HiDAC 123) | Experimental | Subject on this arm will be treated with HiDAC prospectively. |
|
| Historical HiDAC Treatment (HiDAC 135) | Other | Subjects on this arm will be historical controls who have previously received treatment with HiDAC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytarabine | Drug | Subjects on this arm will prospectively receive consolidation therapy with cytarabine. Subjects will be treated with 1000 mg/m2 cytarabine intravenously every 12 hours on Days 1-3 of each consolidation cycle. Subjects will receive up to four consolidation cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Neutropenia | Determine the duration of neutropenia in older patients with de novo AML after consolidation chemotherapy with HiDAC 123, as compared to historical controls treated with HiDAC 135. | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Thrombocytopenia | Determine the duration of thrombocytopenia in older patients with de novo AML after consolidation chemotherapy with HiDAC 123, as compared to historical controls treated with HiDAC 135. | 5 months |
| Incidence of Documented Infections |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jack Hsu, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32608 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prospective HiDAC Treatment (HiDAC 123) | Subject on this arm will be treated with HiDAC prospectively. Cytarabine: Subjects on this arm will prospectively receive consolidation therapy with cytarabine. Subjects will be treated with 1000 mg/m2 cytarabine intravenously every 12 hours on Days 1-3 of each consolidation cycle. Subjects will receive up to four consolidation cycles. |
| FG001 | Historical HiDAC Treatment (HiDAC 135) | Subjects on this arm will be historical controls who have previously received treatment with HiDAC. Cytarabine: Subjects on this arm will have received consolidation therapy with cytarabine between 2/1/2017 and 2/1/2019. Subjects will have received 1000 mg/m2 cytarabine intravenously every 12 hours on days 1, 3, and 5 of each consolidation cycle and will have received up to 4 consolidation cycles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
No participants were enrolled on the historical arm because the study was terminated prior to any participants being enrolled on this arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Prospective HiDAC Treatment (HiDAC 123) | Subject on this arm will be treated with HiDAC prospectively. Cytarabine: Subjects on this arm will prospectively receive consolidation therapy with cytarabine. Subjects will be treated with 1000 mg/m2 cytarabine intravenously every 12 hours on Days 1-3 of each consolidation cycle. Subjects will receive up to four consolidation cycles. |
| 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 | Duration of Neutropenia | Determine the duration of neutropenia in older patients with de novo AML after consolidation chemotherapy with HiDAC 123, as compared to historical controls treated with HiDAC 135. | Data were not collected for subjects on either arm. No subjects were enrolled on the historical control arm. | Posted | 5 months |
|
Adverse events were collected from the time of informed consent until 28 days after the last dose of study treatment or the start of a new chemotherapy regimen (whichever came first). Adverse event data were collected for a maximum of 165 days.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 28 days after the last dose of study treatment or the start of a new chemotherapy regimen (whichever came first). Adverse events were assessed by physical examination, labs, and subject self-reports.
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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 | Prospective HiDAC Treatment (HiDAC 123) | Subject on this arm will be treated with HiDAC prospectively. Cytarabine: Subjects on this arm will prospectively receive consolidation therapy with cytarabine. Subjects will be treated with 1000 mg/m2 cytarabine intravenously every 12 hours on Days 1-3 of each consolidation cycle. Subjects will receive up to four consolidation cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Altered mental status | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Absolute neutrophil count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allison Allegra | University of Florida | 352-294-5691 | allisonallegra3@ufl.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 | Aug 14, 2023 | Nov 17, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
|
| Cytarabine | Drug | Subjects on this arm will have received consolidation therapy with cytarabine between 2/1/2017 and 2/1/2019. Subjects will have received 1000 mg/m2 cytarabine intravenously every 12 hours on days 1, 3, and 5 of each consolidation cycle and will have received up to 4 consolidation cycles. |
|
|
Compare the incidence of documented infections (bloodstream infection, pneumonia, invasive fungal infection, Clostridium difficile infection, typhlitis, and febrile neutropenia) in patients receiving HiDAC 123 and HiDAC 135. |
| 5 months |
| Number of Transfusions | Compare the number of red blood cell and platelet transfusions per cycle in patients receiving HiDAC 123 and HiDAC 135. | 4 months |
| Readmission Rates and Length of Readmission Stay | Compare the incidence of readmission and the length of readmission stay in patients receiving HiDAC 123 and HiDAC 135. | 5 months |
| Time to Next Treatment | Compare the time to next treatment (next chemotherapy cycle, transplant, etc.) in patients receiving HiDAC 123 and HiDAC 135. | 5 months |
| BG001 | Historical HiDAC Treatment (HiDAC 135) | Subjects on this arm will be historical controls who have previously received treatment with HiDAC. Cytarabine: Subjects on this arm will have received consolidation therapy with cytarabine between 2/1/2017 and 2/1/2019. Subjects will have received 1000 mg/m2 cytarabine intravenously every 12 hours on days 1, 3, and 5 of each consolidation cycle and will have received up to 4 consolidation cycles. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects on this arm will be historical controls who have previously received treatment with HiDAC. Cytarabine: Subjects on this arm will have received consolidation therapy with cytarabine between 2/1/2017 and 2/1/2019. Subjects will have received 1000 mg/m2 cytarabine intravenously every 12 hours on days 1, 3, and 5 of each consolidation cycle and will have received up to 4 consolidation cycles. |
|
| Secondary | Duration of Thrombocytopenia | Determine the duration of thrombocytopenia in older patients with de novo AML after consolidation chemotherapy with HiDAC 123, as compared to historical controls treated with HiDAC 135. | Data were not collected for subjects on either arm. No subjects were enrolled on the historical control arm. | Posted | 5 months |
|
|
| Secondary | Incidence of Documented Infections | Compare the incidence of documented infections (bloodstream infection, pneumonia, invasive fungal infection, Clostridium difficile infection, typhlitis, and febrile neutropenia) in patients receiving HiDAC 123 and HiDAC 135. | Data were not collected for subjects on either arm. No subjects were enrolled on the historical control arm. | Posted | 5 months |
|
|
| Secondary | Number of Transfusions | Compare the number of red blood cell and platelet transfusions per cycle in patients receiving HiDAC 123 and HiDAC 135. | Data were not collected for subjects on either arm. No subjects were enrolled on the historical control arm. | Posted | 4 months |
|
|
| Secondary | Readmission Rates and Length of Readmission Stay | Compare the incidence of readmission and the length of readmission stay in patients receiving HiDAC 123 and HiDAC 135. | Data were not collected for subjects on either arm. No subjects were enrolled on the historical control arm. | Posted | 5 months |
|
|
| Secondary | Time to Next Treatment | Compare the time to next treatment (next chemotherapy cycle, transplant, etc.) in patients receiving HiDAC 123 and HiDAC 135. | Data were not collected for subjects on either arm. No subjects were enrolled on the historical control arm. | Posted | 5 months |
|
|
| 2 |
| 5 |
| 4 |
| 5 |
| 5 |
| 5 |
| EG001 | Historical HiDAC Treatment (HiDAC 135) | Subjects on this arm will be historical controls who have previously received treatment with HiDAC. Cytarabine: Subjects on this arm will have received consolidation therapy with cytarabine between 2/1/2017 and 2/1/2019. Subjects will have received 1000 mg/m2 cytarabine intravenously every 12 hours on days 1, 3, and 5 of each consolidation cycle and will have received up to 4 consolidation cycles. | 0 | 0 | 0 | 0 | 0 | 0 |
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Meningoencephalitis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Altered mental status | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006571 |
| Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |