Trial Outcomes & Findings for Study of Repeat Intranodal Injection of Memgen's Cancer Vaccine, Ad-ISF35, in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (NCT NCT00849524)
NCT ID: NCT00849524
Last Updated: 2015-12-30
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
2 years (evaluation will be approx. 4 months per patient)
Results posted on
2015-12-30
Participant Flow
Participant milestones
| Measure |
Ad-ISF35
Ad-ISF35, intranodal injection, 3.3 x 10\^10 ISF35 viral particles, every 2-4 weeks up to six total injections.
ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10\^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Ad-ISF35
Ad-ISF35, intranodal injection, 3.3 x 10\^10 ISF35 viral particles, every 2-4 weeks up to six total injections.
ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10\^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
3
|
Baseline Characteristics
Study of Repeat Intranodal Injection of Memgen's Cancer Vaccine, Ad-ISF35, in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Baseline characteristics by cohort
| Measure |
Ad-ISF35
n=6 Participants
Ad-ISF35, intranodal injection, 3.3 x 10\^10 ISF35 viral particles, every 2-4 weeks up to six total injections.
ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10\^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 years (evaluation will be approx. 4 months per patient)Population: The study was not completed due to unavailability of the study drug, and therefore data were not collected for this Outcome Measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 years (evaluation will be approx. 1 year per patient)Population: The study was not completed due to unavailability of the study drug, and therefore data were not collected for this Outcome Measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 years (evaluation will be approx. 4 months per patient)Population: The study was not completed due to unavailability of the study drug, and therefore data were not collected for this Outcome Measure.
Outcome measures
Outcome data not reported
Adverse Events
Ad-ISF35
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ad-ISF35
n=6 participants at risk
Ad-ISF35, intranodal injection, 3.3 x 10\^10 ISF35 viral particles, every 2-4 weeks up to six total injections.
ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10\^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections.
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|---|---|
|
General disorders
Hyponatremia
|
16.7%
1/6
|
|
Immune system disorders
Flu like syndrome
|
100.0%
6/6
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6
|
|
General disorders
Fever
|
100.0%
6/6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Arthritis (non-septic)
|
50.0%
3/6
|
|
Immune system disorders
Injection site reaction
|
100.0%
6/6
|
|
General disorders
Sweating
|
100.0%
6/6
|
|
General disorders
Fatigue
|
100.0%
6/6
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea-Shortness of breath
|
33.3%
2/6
|
|
General disorders
Anorexia
|
50.0%
3/6
|
|
Renal and urinary disorders
Urinary frequency
|
33.3%
2/6
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6
|
Additional Information
Januario Castro, MD
University of California, San Diego
Phone: (858) 822-6600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place