Trial Outcomes & Findings for Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin as 2nd Line Therapy for Non-Hodgkin's Lymphoma (NHL) (NCT NCT00336583)
NCT ID: NCT00336583
Last Updated: 2018-06-26
Results Overview
The Overall Response Rate was measured by the number of patients per the total treatment population who partially or completely responded to treatment. Response was evaluated according to the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas.
COMPLETED
PHASE2
27 participants
up to 24 weeks
2018-06-26
Participant Flow
A total of 27 patients were enrolled between April and December 2006 from eight institutions in South Korea.
Patients with symptomatic central nervous system involvement and pregnant or breastfeeding women were excluded. Patients with grade 2 or more peripheral neuropathy at the time of study entry were also excluded.
Participant milestones
| Measure |
ESHAOx
The ESHAOx consisted of Etoposide (40 mg per square meter on days 1-4), Methylprednisolone (500 mg on days 1-5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
ESHAOx
The ESHAOx consisted of Etoposide (40 mg per square meter on days 1-4), Methylprednisolone (500 mg on days 1-5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin as 2nd Line Therapy for Non-Hodgkin's Lymphoma (NHL)
Baseline characteristics by cohort
| Measure |
ESHAOx
n=27 Participants
The ESHAOx consisted of Etoposide (40 mg per square meter on days 1-4), Methylprednisolone (500 mg on days 1-5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 10.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
|
Region of Enrollment
Korea, Republic of
|
27 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: up to 24 weeksPopulation: 25 patients who had completed at least 3 cycles of ESHAOx study treatment were analyzed. 2 patients who did not complete 3 cycles of study treatment were excluded from the response analysis.
The Overall Response Rate was measured by the number of patients per the total treatment population who partially or completely responded to treatment. Response was evaluated according to the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas.
Outcome measures
| Measure |
ESHAOx
n=25 Participants
The ESHAOx consisted of Etoposide (40 mg per square meter on days 1-4), Methylprednisolone (500 mg on days 1-5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
|
|---|---|
|
Overall Response Rate
|
17 pariticipants
|
SECONDARY outcome
Timeframe: up to 24 weeksPopulation: The 27 patients received a total of 103 cycles of the ESHAOx treatment, with a median number of four cycles per patient. Except one who was lost to follow-up after one cycle, 26 patients were assessable for toxicity.
graded by National Cancer Institute Common Toxicity Criteria of Adverse Event version 3.0
Outcome measures
| Measure |
ESHAOx
n=26 Participants
The ESHAOx consisted of Etoposide (40 mg per square meter on days 1-4), Methylprednisolone (500 mg on days 1-5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
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|---|---|
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Worst Toxicity Grade by Patient
Grade 1 neutropenia
|
3 participants
|
|
Worst Toxicity Grade by Patient
Grade 2 neutropenia
|
3 participants
|
|
Worst Toxicity Grade by Patient
Grade 3 neutropenia
|
2 participants
|
|
Worst Toxicity Grade by Patient
Grade 4 neutropenia
|
13 participants
|
|
Worst Toxicity Grade by Patient
Grade 1 thrombocytopenia
|
4 participants
|
|
Worst Toxicity Grade by Patient
Grade 2 thrombocytopenia
|
3 participants
|
|
Worst Toxicity Grade by Patient
Grade 3 thrombocytopenia
|
3 participants
|
|
Worst Toxicity Grade by Patient
Grade 4 thrombocytopenia
|
6 participants
|
Adverse Events
ESHAOx
Serious adverse events
| Measure |
ESHAOx
n=26 participants at risk
The ESHAOx consisted of Etoposide (40 mg per square meter on days 1-4), Methylprednisolone (500 mg on days 1-5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
|
|---|---|
|
Infections and infestations
febrile neutropenia
|
3.8%
1/26 • Number of events 1 • 9 months
|
Other adverse events
| Measure |
ESHAOx
n=26 participants at risk
The ESHAOx consisted of Etoposide (40 mg per square meter on days 1-4), Methylprednisolone (500 mg on days 1-5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
|
|---|---|
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Blood and lymphatic system disorders
neutropenia grade 1
|
11.5%
3/26 • Number of events 3 • 9 months
|
|
Blood and lymphatic system disorders
neutropenia grade 2
|
11.5%
3/26 • Number of events 3 • 9 months
|
|
Blood and lymphatic system disorders
neutropenia grade 3
|
7.7%
2/26 • Number of events 2 • 9 months
|
|
Blood and lymphatic system disorders
neutropenia grade 4
|
50.0%
13/26 • Number of events 13 • 9 months
|
|
Blood and lymphatic system disorders
thrombocytopenia grade 1
|
15.4%
4/26 • Number of events 4 • 9 months
|
|
Blood and lymphatic system disorders
thrombocytopenia grade 2
|
11.5%
3/26 • Number of events 3 • 9 months
|
|
Blood and lymphatic system disorders
thrombocytopenia grade 3
|
11.5%
3/26 • Number of events 3 • 9 months
|
|
Blood and lymphatic system disorders
thrombocytopenia grade 4
|
23.1%
6/26 • Number of events 6 • 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place