Trial Outcomes & Findings for Phase I/II - Brentuximab/5-Azacytidine in Acute Myeloid Leukemia (AML) (NCT NCT02096042)
NCT ID: NCT02096042
Last Updated: 2023-10-10
Results Overview
MTD defined as maximum dose at which \<33% of patients experience a dose-limiting toxicity (DLT) during cycle 1.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
1 participants
Primary outcome timeframe
After 1, 28 day cycle
Results posted on
2023-10-10
Participant Flow
Recruitment Period: April 24, 2014 to July 08, 2015. All recruitment done at The University of Texas MD Anderson Cancer Center.
Study was terminated early due to low enrollment.
Participant milestones
| Measure |
Brentuximab Vedotin
Pilot Phase: Starting dose of Brentuximab Vedotin 1.2 mg/kg intravenous (IV) infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle (+/- 3 days).
|
Brentuximab Vedotin + 5-Azacytidine
Phase I Dose-Escalation Phase: Starting dose of Brentuximab Vedotin 1.0 mg/kg IV (starting dose level 1), or one-dose level lower than the established MTD if the pilot portion of the study establishes a lower MTD, infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle. 5-azacytidine at 75 mg/m2/day IV or subcutaneously on days 1-7 every 28 days.
|
MTD Brentuximab Vedotin + 5-Azacytidine
Phase II Dose-Expansion Phase: Brentuximab Vedotin at MTD from dose-escalation phase IV on Days 1, 8, and 15 of each 28-day cycle. 5-Azacytidine at 75 mg/m2/day IV or subcutaneously on days 1-7 every 28 days.Up to 12 cycles of treatment (weekly + monthly combined).
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Brentuximab Vedotin
Pilot Phase: Starting dose of Brentuximab Vedotin 1.2 mg/kg intravenous (IV) infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle (+/- 3 days).
|
Brentuximab Vedotin + 5-Azacytidine
Phase I Dose-Escalation Phase: Starting dose of Brentuximab Vedotin 1.0 mg/kg IV (starting dose level 1), or one-dose level lower than the established MTD if the pilot portion of the study establishes a lower MTD, infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle. 5-azacytidine at 75 mg/m2/day IV or subcutaneously on days 1-7 every 28 days.
|
MTD Brentuximab Vedotin + 5-Azacytidine
Phase II Dose-Expansion Phase: Brentuximab Vedotin at MTD from dose-escalation phase IV on Days 1, 8, and 15 of each 28-day cycle. 5-Azacytidine at 75 mg/m2/day IV or subcutaneously on days 1-7 every 28 days.Up to 12 cycles of treatment (weekly + monthly combined).
|
|---|---|---|---|
|
Overall Study
Disease Progression
|
1
|
0
|
0
|
Baseline Characteristics
Phase I/II - Brentuximab/5-Azacytidine in Acute Myeloid Leukemia (AML)
Baseline characteristics by cohort
| Measure |
Brentuximab Vedotin
n=1 Participants
Pilot Phase: Starting dose of Brentuximab Vedotin 1.2 mg/kg intravenous (IV) infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle (+/- 3 days).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 1, 28 day cyclePopulation: Study terminated early.
MTD defined as maximum dose at which \<33% of patients experience a dose-limiting toxicity (DLT) during cycle 1.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Response assessed after four 28-day cycles, up to 120 daysPopulation: Study was stopped with only one participant; no analysis done on outcome.
Response defined as number of participants with complete response (CR), CR with incomplete platelet recovery (CRp), CR with insufficient hematological recovery (CRi) or partial remission (PR).
Outcome measures
Outcome data not reported
Adverse Events
Brentuximab Vedotin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Brentuximab Vedotin
n=1 participants at risk
Pilot Phase: Starting dose of Brentuximab Vedotin 1.2 mg/kg intravenous (IV) infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle (+/- 3 days).
|
|---|---|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
100.0%
1/1 • Number of events 1 • Adverse event collection for first 28-day cycle.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
1/1 • Number of events 1 • Adverse event collection for first 28-day cycle.
|
|
Musculoskeletal and connective tissue disorders
Pain - extremity
|
100.0%
1/1 • Number of events 1 • Adverse event collection for first 28-day cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
100.0%
1/1 • Number of events 1 • Adverse event collection for first 28-day cycle.
|
|
Infections and infestations
Urinary Tract Infection
|
100.0%
1/1 • Number of events 1 • Adverse event collection for first 28-day cycle.
|
|
Infections and infestations
Sepsis
|
100.0%
1/1 • Number of events 1 • Adverse event collection for first 28-day cycle.
|
Additional Information
Nitin Jain, MD/Assistant Professor, Leukemia
The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-7734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place