Trial Outcomes & Findings for DT388IL3 Fusion Protein in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes (NCT NCT00397579)
NCT ID: NCT00397579
Last Updated: 2019-04-23
Results Overview
Patients will be treated with a maximum of five doses of approximately 15min IV infusions of DT388IL3/SL-401 over a ten day period at a maximum of once daily. Response to Treatment will be evaluated as follows: Complete response (CR): patient has a normal whole blood count; platelets with absent blasts in peripheral blood or marrow; no evidence of nodal involvement or liver/spleen involvement; no skin lesion involvement. Partial Response (PR); patient experiences a decrease of 50% or more in marrow blasts and skin lesions; and there is a decrease in the size of the nodes/liver/spleen. Stable Disease (SD); failure to achieve at least PR, and there is no evidence of progression for 2 months. Failure: death during treatment or disease progression characterized by an increase in the percentage bone marrow blast or an increase in skin or node/liver or spleen size. Reported is the percentage of participants experiencing either CR, PR or SD.
COMPLETED
PHASE1/PHASE2
11 participants
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 months
2019-04-23
Participant Flow
Participant milestones
| Measure |
SL-401
Patients will be treated with a maximum of five doses of approximately 15min IV infusions of DT388IL3/SL-401 over a ten day period at a maximum of once daily.
DT388IL3: Intravenously via a 3 cc plastic syringe as a 15 minute bolus infusion daily for five days.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DT388IL3 Fusion Protein in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes
Baseline characteristics by cohort
| Measure |
SL-401
n=11 Participants
Patients will be treated with a maximum of five doses of approximately 15min IV infusions of DT388IL3/SL-401 over a ten day period at a maximum of once daily.
DT388IL3: Intravenously via a 3 cc plastic syringe as a 15 minute bolus infusion daily for five 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
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 monthsPatients will be treated with a maximum of five doses of approximately 15min IV infusions of DT388IL3/SL-401 over a ten day period at a maximum of once daily. Response to Treatment will be evaluated as follows: Complete response (CR): patient has a normal whole blood count; platelets with absent blasts in peripheral blood or marrow; no evidence of nodal involvement or liver/spleen involvement; no skin lesion involvement. Partial Response (PR); patient experiences a decrease of 50% or more in marrow blasts and skin lesions; and there is a decrease in the size of the nodes/liver/spleen. Stable Disease (SD); failure to achieve at least PR, and there is no evidence of progression for 2 months. Failure: death during treatment or disease progression characterized by an increase in the percentage bone marrow blast or an increase in skin or node/liver or spleen size. Reported is the percentage of participants experiencing either CR, PR or SD.
Outcome measures
| Measure |
SL-401
n=11 Participants
Patients will be treated with a maximum of five doses of approximately 15min IV infusions of DT388IL3/SL-401 over a ten day period at a maximum of once daily.
DT388IL3: Intravenously via a 3 cc plastic syringe as a 15 minute bolus infusion daily for five days.
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|---|---|
|
Overall Response Rate (CR+PR+SD): Percentage of Participants Experiencing Response
|
81.8 percentage of participants
|
Adverse Events
SL-401
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SL-401
n=11 participants at risk
Patients will be treated with a maximum of five doses of approximately 15min IV infusions of DT388IL3/SL-401 over a ten day period at a maximum of once daily.
DT388IL3: Intravenously via a 3 cc plastic syringe as a 15 minute bolus infusion daily for five days.
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|---|---|
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Hepatobiliary disorders
AST
|
36.4%
4/11 • Number of events 4 • 10 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.1%
1/11 • Number of events 1 • 10 days
|
|
Hepatobiliary disorders
ALT
|
27.3%
3/11 • Number of events 3 • 10 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
36.4%
4/11 • Number of events 4 • 10 days
|
|
Blood and lymphatic system disorders
Hyponatremia
|
9.1%
1/11 • Number of events 1 • 10 days
|
Additional Information
Clinical Research Office
University of Texas Southwestern Medical Center at Dallas
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place