Trial Outcomes & Findings for Phase II Study of ONTAK in Previously Treated Patients With Low-grade Non-Hodgkin's Lymphoma (NHL) (NCT NCT00051025)
NCT ID: NCT00051025
Last Updated: 2012-07-13
Results Overview
Complete response: achievement of a complete regression for \>4 weeks of all palpable and x-ray demonstrable disease and bone marrow disease. Partial response: response to therapy with a 75% reduction in the greatest diameters of the measurable lesions for \>4 weeks and had indeterminate bone marrow biopsy
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
24 Weeks
Results posted on
2012-07-13
Participant Flow
This study was recruited at 6 centers in U.S. during the period of 18-May-2000 to 12-May-2001
Participant milestones
| Measure |
Ontak 4-Course Group
Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
|
Ontak 8-Course Group
Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Ontak 4-Course Group
Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
|
Ontak 8-Course Group
Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
|
|---|---|---|
|
Overall Study
Progressive Disease
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Phase II Study of ONTAK in Previously Treated Patients With Low-grade Non-Hodgkin's Lymphoma (NHL)
Baseline characteristics by cohort
| Measure |
Ontak 4-Course Group
n=5 Participants
Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
|
Ontak 8-Course Group
n=4 Participants
Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age Continuous
|
65.4 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 15.5 • n=7 Participants
|
63.3 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 WeeksPopulation: Intent-to-treat
Complete response: achievement of a complete regression for \>4 weeks of all palpable and x-ray demonstrable disease and bone marrow disease. Partial response: response to therapy with a 75% reduction in the greatest diameters of the measurable lesions for \>4 weeks and had indeterminate bone marrow biopsy
Outcome measures
| Measure |
Ontak 4-Course Group
n=5 Participants
Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
|
Ontak 8-Course Group
n=4 Participants
Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
|
|---|---|---|
|
Objective Clinical Response: Complete Response (CR) or Partial Response (PR) at Week 24, or, in the Event of Lengthened Cycle Intervals, at the End of Cycle 8.
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From beginning of response to time of relapsePopulation: Intent-to-treat. Please note: Data represent 1 subject in each treatment group who responded.
The duration of response was defined as the time interval from start of the first response (CR or PR) to the time of documented disease progression.
Outcome measures
| Measure |
Ontak 4-Course Group
n=1 Participants
Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
|
Ontak 8-Course Group
n=1 Participants
Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
|
|---|---|---|
|
Duration of Response
|
175 Days
|
797 Days
|
SECONDARY outcome
Timeframe: From start of first treatmentOutcome measures
Outcome data not reported
Adverse Events
Ontak 4-Course Group
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Ontak 8-Course Group
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ontak 4-Course Group
n=5 participants at risk
Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
|
Ontak 8-Course Group
n=4 participants at risk
Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/5
|
25.0%
1/4
|
|
General disorders
Chest Pain
|
0.00%
0/5
|
25.0%
1/4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progression of Mantle Cell Lymphoma
|
0.00%
0/5
|
25.0%
1/4
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
20.0%
1/5
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
20.0%
1/5
|
0.00%
0/4
|
Other adverse events
| Measure |
Ontak 4-Course Group
n=5 participants at risk
Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
|
Ontak 8-Course Group
n=4 participants at risk
Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
|
|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
1/5
|
25.0%
1/4
|
|
Psychiatric disorders
Insomnia
|
40.0%
2/5
|
50.0%
2/4
|
|
Nervous system disorders
Headache
|
0.00%
0/5
|
50.0%
2/4
|
|
Cardiac disorders
Tachycardia
|
20.0%
1/5
|
50.0%
2/4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5
|
25.0%
1/4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
60.0%
3/5
|
0.00%
0/4
|
|
Gastrointestinal disorders
Abdominal Distention
|
20.0%
1/5
|
25.0%
1/4
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/5
|
50.0%
2/4
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/5
|
50.0%
2/4
|
|
Gastrointestinal disorders
Lip Blister
|
20.0%
1/5
|
25.0%
1/4
|
|
Gastrointestinal disorders
Nausea
|
60.0%
3/5
|
50.0%
2/4
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5
|
25.0%
1/4
|
|
Skin and subcutaneous tissue disorders
Rash
|
40.0%
2/5
|
25.0%
1/4
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
20.0%
1/5
|
25.0%
1/4
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
20.0%
1/5
|
25.0%
1/4
|
|
General disorders
Asthenia
|
20.0%
1/5
|
25.0%
1/4
|
|
General disorders
Chest Discomfort
|
0.00%
0/5
|
50.0%
2/4
|
|
General disorders
Fatigue
|
60.0%
3/5
|
75.0%
3/4
|
|
General disorders
Oedema Peripheral
|
40.0%
2/5
|
25.0%
1/4
|
|
General disorders
Pain
|
20.0%
1/5
|
50.0%
2/4
|
|
General disorders
Pyrexia
|
40.0%
2/5
|
50.0%
2/4
|
Additional Information
Eisai Inc
Eisai Call Center
Phone: 888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place