Trial Outcomes & Findings for Decitabine and Cedazuridine in Combination With Venetoclax for the Treatment of Patients Who Have Relapsed Acute Myeloid Leukemia After Donor Stem Cell Transplant (NCT NCT05799079)
NCT ID: NCT05799079
Last Updated: 2026-01-09
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
9 months
Results posted on
2026-01-09
Participant Flow
Participant milestones
| Measure |
Dose Level -2
DEC-C 100mg/35mg D1-4 Venetoclax 400 mg per day (D1-21 per cycle)
|
Phase 2 Expansion
Treatment dose determined from Dose De-escalation Phase
|
Dose Level 1
DEC-C 100mg/35mg D1-5 Venetoclax 400 mg per day (continuous)
|
Dose Level -1
DEC-C 100mg/35mg D1-4 Venetoclax 400 mg per day (continuous)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Decitabine and Cedazuridine in Combination With Venetoclax for the Treatment of Patients Who Have Relapsed Acute Myeloid Leukemia After Donor Stem Cell Transplant
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=1 Participants
DEC-C 100mg/35mg D1-5 Venetoclax 400 mg per day (continuous)
|
|---|---|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION NA • n=9 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 9 monthsOutcome measures
| Measure |
Dose Level 1
n=1 Participants
DEC-C 100mg/35mg D1-5 Venetoclax 400 mg per day (continuous)
|
|---|---|
|
Number of Participants That Achieved a Complete Response to Therapy
|
0 Participants
|
SECONDARY outcome
Timeframe: 9 monthsOutcome measures
| Measure |
Dose Level 1
n=1 Participants
DEC-C 100mg/35mg D1-5 Venetoclax 400 mg per day (continuous)
|
|---|---|
|
Number of Participants That Achieved a Partial Response to Therapy
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 24 months post-treatment.Population: Data not collected for this outcome measure as study was terminated early.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 months post-treatment.Population: Data not collected for this outcome measure as study was terminated early.
Relapse free survival was estimated by the Kaplan-Meier Method
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 months post-treatment.Population: Data not collected for this outcome measure as study was terminated early.
Overall survival was estimated using the Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.List of adverse events that were attributed as related to study treatment is reported. All occurrences of a particular adverse event is reported.
Outcome measures
| Measure |
Dose Level 1
n=1 Participants
DEC-C 100mg/35mg D1-5 Venetoclax 400 mg per day (continuous)
|
|---|---|
|
Number of Treatment-related Adverse Events
|
5 adverse events of dehydration
|
SECONDARY outcome
Timeframe: Up to 24 months post-treatment.Population: Data not collected for this outcome measure as study was terminated early.
Outcome measures
Outcome data not reported
Adverse Events
Dose Level 1
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Dose Level 1
n=1 participants at risk
DEC-C 100mg/35mg D1-5 Venetoclax 400 mg per day (continuous)
|
|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
100.0%
1/1 • Number of events 1 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
Other adverse events
| Measure |
Dose Level 1
n=1 participants at risk
DEC-C 100mg/35mg D1-5 Venetoclax 400 mg per day (continuous)
|
|---|---|
|
Metabolism and nutrition disorders
Hypokalemia
|
100.0%
1/1 • Number of events 3 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
100.0%
1/1 • Number of events 1 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
1/1 • Number of events 2 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Psychiatric disorders
Insomnia
|
100.0%
1/1 • Number of events 1 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Investigations
Investigations - Other, specify
|
100.0%
1/1 • Number of events 7 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
1/1 • Number of events 1 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 5 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Number of events 12 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
1/1 • Number of events 2 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Psychiatric disorders
Anxiety
|
100.0%
1/1 • Number of events 1 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
1/1 • Number of events 1 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
100.0%
1/1 • Number of events 1 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
100.0%
1/1 • Number of events 1 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Gastrointestinal disorders
Constipation
|
100.0%
1/1 • Number of events 1 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
100.0%
1/1 • Number of events 4 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Psychiatric disorders
Depression
|
100.0%
1/1 • Number of events 1 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Nervous system disorders
Dizziness
|
100.0%
1/1 • Number of events 7 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
100.0%
1/1 • Number of events 2 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 5 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • Number of events 1 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
1/1 • Number of events 1 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
1/1 • Number of events 3 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
100.0%
1/1 • Number of events 2 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
100.0%
1/1 • Number of events 1 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
100.0%
1/1 • Number of events 1 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Investigations
Neutrophil count decreased
|
100.0%
1/1 • Number of events 11 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
100.0%
1/1 • Number of events 1 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
100.0%
1/1 • Number of events 1 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Investigations
Platelet count decreased
|
100.0%
1/1 • Number of events 22 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
100.0%
1/1 • Number of events 1 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Infections and infestations
Skin infection
|
100.0%
1/1 • Number of events 2 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
100.0%
1/1 • Number of events 1 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
1/1 • Number of events 4 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
|
Investigations
White blood cell decreased
|
100.0%
1/1 • Number of events 8 • The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place