Trial Outcomes & Findings for Accelerated Dose Schedule of Cytarabine Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML) in Complete Remission (NCT NCT04914676)

NCT ID: NCT04914676

Last Updated: 2025-01-16

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: 5 months
• Results posted on: 2025-01-16

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	5	0
Overall Study COMPLETED	2	0
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Measure	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.	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.
Overall Study Study termination	3	0

Baseline Characteristics

Accelerated Dose Schedule of Cytarabine Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML) in Complete Remission

Baseline characteristics by cohort

Measure	Prospective HiDAC Treatment (HiDAC 123) n=5 Participants 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.	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.	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	66.8 years n=5 Participants	—	66.8 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	—	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	—	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	—	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	—	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 months

Population: Data were not collected for subjects on either arm. No subjects were enrolled on the historical control arm.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 months

Population: Data were not collected for subjects on either arm. No subjects were enrolled on the historical control arm.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 months

Population: Data were not collected for subjects on either arm. No subjects were enrolled on the historical control arm.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 months

Population: Data were not collected for subjects on either arm. No subjects were enrolled on the historical control arm.

Compare the number of red blood cell and platelet transfusions per cycle in patients receiving HiDAC 123 and HiDAC 135.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 months

Population: Data were not collected for subjects on either arm. No subjects were enrolled on the historical control arm.

Compare the incidence of readmission and the length of readmission stay in patients receiving HiDAC 123 and HiDAC 135.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 months

Population: Data were not collected for subjects on either arm. No subjects were enrolled on the historical control arm.

Compare the time to next treatment (next chemotherapy cycle, transplant, etc.) in patients receiving HiDAC 123 and HiDAC 135.

Outcome measures

Outcome data not reported

Adverse Events

Prospective HiDAC Treatment (HiDAC 123)

Serious events: 4 serious events

Other events: 5 other events

Deaths: 2 deaths

Historical HiDAC Treatment (HiDAC 135)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Prospective HiDAC Treatment (HiDAC 123) n=5 participants at risk 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.	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.
Nervous system disorders Altered mental status	20.0% 1/5 • 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.	— 0/0 • 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.
Blood and lymphatic system disorders Anemia	20.0% 1/5 • 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.	— 0/0 • 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.
Infections and infestations Lung infection	20.0% 1/5 • 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.	— 0/0 • 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.
Investigations Platelet count decreased	20.0% 1/5 • 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.	— 0/0 • 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.
Infections and infestations Meningoencephalitis	20.0% 1/5 • 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.	— 0/0 • 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.
Infections and infestations Sepsis	20.0% 1/5 • 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.	— 0/0 • 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.

Other adverse events

Measure	Prospective HiDAC Treatment (HiDAC 123) n=5 participants at risk 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.	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.
Investigations Absolute neutrophil count decreased	20.0% 1/5 • 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.	— 0/0 • 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.
Investigations Alanine aminotransferase increased	20.0% 1/5 • 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.	— 0/0 • 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.
Nervous system disorders Altered mental status	20.0% 1/5 • 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.	— 0/0 • 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.
Blood and lymphatic system disorders Anemia	100.0% 5/5 • 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.	— 0/0 • 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.
Investigations Lymphocyte count decreased	100.0% 5/5 • 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.	— 0/0 • 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.
Investigations Neutrophil count decreased	80.0% 4/5 • 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.	— 0/0 • 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.
Investigations Platelet count decreased	100.0% 5/5 • 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.	— 0/0 • 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.
Investigations White blood cell decreased	100.0% 5/5 • 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.	— 0/0 • 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.

Additional Information

Allison Allegra

University of Florida

Phone: 352-294-5691

Email: allisonallegra3@ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place