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Trial Outcomes & Findings for AZD1775 in Advanced Acute Myeloid Leukemia, Myelodysplastic Syndrome and Myelofibrosis (NCT NCT03718143)

NCT ID: NCT03718143

Last Updated: 2020-06-02

Results Overview

Less than 5% blasts in a non-hypocellular marrow with a granulocyte count ≥ 1.0, and a platelets count of ≥ 100 with complete resolution of extramedullary disease and absence of peripheral blood blasts.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

4 months

Results posted on

2020-06-02

Participant Flow

Participant milestones

Participant milestones
Measure
Arm A: Elderly Newly Diagnosed AML
Combination AZD1775 with AraC Elderly, newly diagnosed AML Combination AZD1775 with AraC: AZD1775 days 1-5 \& 8-12 AraC days 1-5 \& 8-12
Arm B:Relapsed AML and MDS
Combination AZD1775 with AraC Relapsed/Refractory AML \& HMA failure AML/ MDS Combination AZD1775 with AraC: AZD1775 days 1-5 \& 8-12 AraC days 1-5 \& 8-12
Arm C: Relapsed AML, MDS and MF
AZD1775 only Relapsed/Refractory AML \& HMA failure AML/ MDS and Relapsed/Refractory Primary \& Secondary MF AZD1775 only: AZD1775 days 1-5 \& 8-12
Overall Study
STARTED
3
2
1
Overall Study
COMPLETED
0
0
0
Overall Study
NOT COMPLETED
3
2
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Arm A: Elderly Newly Diagnosed AML
Combination AZD1775 with AraC Elderly, newly diagnosed AML Combination AZD1775 with AraC: AZD1775 days 1-5 \& 8-12 AraC days 1-5 \& 8-12
Arm B:Relapsed AML and MDS
Combination AZD1775 with AraC Relapsed/Refractory AML \& HMA failure AML/ MDS Combination AZD1775 with AraC: AZD1775 days 1-5 \& 8-12 AraC days 1-5 \& 8-12
Arm C: Relapsed AML, MDS and MF
AZD1775 only Relapsed/Refractory AML \& HMA failure AML/ MDS and Relapsed/Refractory Primary \& Secondary MF AZD1775 only: AZD1775 days 1-5 \& 8-12
Overall Study
Death
1
0
0
Overall Study
Progression of Disease
1
0
0
Overall Study
Withdrawal of Informed Consent
1
2
1

Baseline Characteristics

AZD1775 in Advanced Acute Myeloid Leukemia, Myelodysplastic Syndrome and Myelofibrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Total Participants
n=6 Participants
Participants from all 3 arms: Arm A: Elderly Newly Diagnosed AML Arm B: Relapsed AML and MDS Arm C: Relapsed AML, MDS, and MF Baseline information cannot be separated by diagnoses due to data privacy reasons
Age, Categorical
<=18 years
0 Participants
n=93 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
n=93 Participants
Age, Categorical
>=65 years
5 Participants
n=93 Participants
Sex: Female, Male
Female
0 Participants
n=93 Participants
Sex: Female, Male
Male
6 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
Race (NIH/OMB)
Asian
0 Participants
n=93 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=93 Participants
Race (NIH/OMB)
White
2 Participants
n=93 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=93 Participants
Region of Enrollment
United States
6 participants
n=93 Participants

PRIMARY outcome

Timeframe: 4 months

Population: No data was collected for this outcome measure due to early termination of study.

Less than 5% blasts in a non-hypocellular marrow with a granulocyte count ≥ 1.0, and a platelets count of ≥ 100 with complete resolution of extramedullary disease and absence of peripheral blood blasts.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 months

Population: No data was collected for this outcome measure due to early termination of study.

is called if patient meets all CR criteria except for residual neutropenia (ANC\<1 x109/L) or thrombocytopenia (platelets\<100 x109/L)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 Months

Population: No data was collected for this outcome measure due to early termination of study.

The absence of chromosome abnormalities (if present at diagnosis) on conventional cytogenetic study using G-banding (at least 10 metaphases present).

Outcome measures

Outcome data not reported

Adverse Events

Arm A: Elderly Newly Diagnosed AML

Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths

Arm B:Relapsed AML and MDS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Arm C: Relapsed AML, MDS and MF

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Arm A: Elderly Newly Diagnosed AML
n=3 participants at risk
Combination AZD1775 with AraC Elderly, newly diagnosed AML Combination AZD1775 with AraC: AZD1775 days 1-5 \& 8-12 AraC days 1-5 \& 8-12
Arm B:Relapsed AML and MDS
n=2 participants at risk
Combination AZD1775 with AraC Relapsed/Refractory AML \& HMA failure AML/ MDS Combination AZD1775 with AraC: AZD1775 days 1-5 \& 8-12 AraC days 1-5 \& 8-12
Arm C: Relapsed AML, MDS and MF
n=1 participants at risk
AZD1775 only Relapsed/Refractory AML \& HMA failure AML/ MDS and Relapsed/Refractory Primary \& Secondary MF AZD1775 only: AZD1775 days 1-5 \& 8-12
General disorders
Progression of Disease
33.3%
1/3 • 4 months
0.00%
0/2 • 4 months
0.00%
0/1 • 4 months

Other adverse events

Adverse event data not reported

Additional Information

Rachael Keller, Sr. Regulatory Specialist

NYU Langone Health - PCC CTO

Phone: 929-455-2453

Results disclosure agreements

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