Trial Outcomes & Findings for Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma (NCT NCT02137096)
NCT ID: NCT02137096
Last Updated: 2019-06-24
Results Overview
To evaluate the response rates for patients undergoing high dose conditioning using Etoposide, Carboplatin and Ifosfamide followed by autologous stem cell transplantation for the treatment of recurrent NPC in children, adolescents, and young adults.
TERMINATED
PHASE3
1 participants
12 months after completion of treatment
2019-06-24
Participant Flow
The protocol was terminated due to poor enrollment.
Participant milestones
| Measure |
High Dose Conditioning
Single arm - receives high dose Etoposide phosphate, Ifosfamide, and Carboplatin followed by Autologous Stem Cell Transplantation
Etoposide phosphate: Etoposide is one of three drugs used in the high-dose conditioning phase
Carboplatin: Carboplatin is one of the drugs used in the high-dose conditioning phase.
Ifosfamide: Ifosfamide is one of the drugs used in the high-dose conditioning phase
Autologous Stem Cell Transplantation: Autologous Stem Cell Transplantation follows the high-dose chemotherapy phase of the arm.
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
High Dose Conditioning
n=1 Participants
Single arm - receives high dose Etoposide phosphate, Ifosfamide, and Carboplatin followed by Autologous Stem Cell Transplantation
Etoposide phosphate: Etoposide is one of three drugs used in the high-dose conditioning phase
Carboplatin: Carboplatin is one of the drugs used in the high-dose conditioning phase.
Ifosfamide: Ifosfamide is one of the drugs used in the high-dose conditioning phase
Autologous Stem Cell Transplantation: Autologous Stem Cell Transplantation follows the high-dose chemotherapy phase of the arm.
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|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=1 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=1 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=1 Participants
|
PRIMARY outcome
Timeframe: 12 months after completion of treatmentPopulation: Due to only one subject being enrolled data analysis was completed
To evaluate the response rates for patients undergoing high dose conditioning using Etoposide, Carboplatin and Ifosfamide followed by autologous stem cell transplantation for the treatment of recurrent NPC in children, adolescents, and young adults.
Outcome measures
Outcome data not reported
Adverse Events
High Dose Conditioning
Serious adverse events
| Measure |
High Dose Conditioning
n=1 participants at risk
Single arm - receives high dose Etoposide phosphate, Ifosfamide, and Carboplatin followed by Autologous Stem Cell Transplantation
Etoposide phosphate: Etoposide is one of three drugs used in the high-dose conditioning phase
Carboplatin: Carboplatin is one of the drugs used in the high-dose conditioning phase.
Ifosfamide: Ifosfamide is one of the drugs used in the high-dose conditioning phase
Autologous Stem Cell Transplantation: Autologous Stem Cell Transplantation follows the high-dose chemotherapy phase of the arm.
|
|---|---|
|
Blood and lymphatic system disorders
Grade III Hypophosphatemia
|
100.0%
1/1 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Grade III Mucositis
|
100.0%
1/1 • Number of events 1 • 6 months
|
|
Immune system disorders
Sepsis
|
100.0%
1/1 • Number of events 1 • 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place