Trial Outcomes & Findings for Dose Escalation Trial of Denileukin Diftitox (Ontak) Post Autologous Transplantation (NCT NCT01251952)
NCT ID: NCT01251952
Last Updated: 2017-06-20
Results Overview
After drug infusion, participants will be closely monitored for at least 4 hours for side effects
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
2 participants
Primary outcome timeframe
Up to 21 days post transplant
Results posted on
2017-06-20
Participant Flow
Cancer center clinic.
Participant milestones
| Measure |
Denileukin Diftitox (Ontak)
Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.
Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.
Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Denileukin Diftitox (Ontak)
Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.
Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.
Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Dose Escalation Trial of Denileukin Diftitox (Ontak) Post Autologous Transplantation
Baseline characteristics by cohort
| Measure |
Denileukin Diftitox (Ontak)
n=2 Participants
Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.
Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.
Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360.
|
|---|---|
|
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
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 21 days post transplantAfter drug infusion, participants will be closely monitored for at least 4 hours for side effects
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: days 0 and 21 post autologous stem cell transplantationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: days 0 and 21 post autologous stem cell transplantationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: days 0 and 21 post autologous stem cell transplantationDuring hospitalization stay (approximately 2 weeks), participants will receive injections of G-CSF on a daily basis starting on Day 6 and ending when white blood cells have engrafted. Participants usually remain hospitalized until engraftment.
Outcome measures
Outcome data not reported
Adverse Events
Denileukin Diftitox (Ontak)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Denileukin Diftitox (Ontak)
n=2 participants at risk
Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.
Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.
Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360.
|
|---|---|
|
Metabolism and nutrition disorders
Low BUN
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
100.0%
2/2 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
1/2 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
50.0%
1/2 • Number of events 1
|
|
Infections and infestations
Febrile neutropenia
|
50.0%
1/2 • Number of events 1
|
|
Infections and infestations
Streptococcus in urine
|
50.0%
1/2 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Zaid Al-Kadhimi, M.D.
Barbara Ann Karmanos Cancer Institute
Phone: (313) 576-8022
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place