Trial Outcomes & Findings for DepoCyt for Active Lymphomatous or Leukemic Meningitis (NCT NCT00523939)
NCT ID: NCT00523939
Last Updated: 2013-06-17
Results Overview
To evaluate response rate using intrathecal DepoCytTM in two cohorts of patients, one with active lymphomatous meningitis and another with active leukemic meningitis.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
1 year
Results posted on
2013-06-17
Participant Flow
Recruitment June 2006 - September 2008. Study stopped early due to poor accrual.
Participant milestones
| Measure |
Lymphomatous
Subjects with Lymphomatous Meningitis
|
Leukemic
Subjects with Leukemic Meningitis
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DepoCyt for Active Lymphomatous or Leukemic Meningitis
Baseline characteristics by cohort
| Measure |
Lymphomatous
n=2 Participants
Subjects with Lymphomatous Meningitis
|
Leukemic
n=2 Participants
Subjects with Leukemic Meningitis
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Primary outcome measure was not assessed due to early study termination.
To evaluate response rate using intrathecal DepoCytTM in two cohorts of patients, one with active lymphomatous meningitis and another with active leukemic meningitis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
Adverse Events
All Subjects
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Subjects
n=4 participants at risk
Subjects with Lymphomatous or Leukemic Meningitis.
|
|---|---|
|
General disorders
Death not associated with CTCAE term, disease progression
|
25.0%
1/4 • Number of events 1 • 9 months
|
|
Infections and infestations
Infection
|
25.0%
1/4 • Number of events 2 • 9 months
|
|
Nervous system disorders
Arachnoiditis
|
25.0%
1/4 • Number of events 1 • 9 months
|
Other adverse events
| Measure |
All Subjects
n=4 participants at risk
Subjects with Lymphomatous or Leukemic Meningitis.
|
|---|---|
|
Metabolism and nutrition disorders
hypocalcemia
|
25.0%
1/4 • Number of events 1 • 9 months
|
|
Psychiatric disorders
Confusion
|
25.0%
1/4 • Number of events 1 • 9 months
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • 9 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
1/4 • Number of events 1 • 9 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
25.0%
1/4 • Number of events 1 • 9 months
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Slurred speech
|
25.0%
1/4 • Number of events 1 • 9 months
|
|
Blood and lymphatic system disorders
Platelets
|
50.0%
2/4 • Number of events 2 • 9 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • Number of events 1 • 9 months
|
|
Nervous system disorders
Seizure
|
25.0%
1/4 • Number of events 1 • 9 months
|
|
Renal and urinary disorders
Urinary frequency
|
50.0%
2/4 • Number of events 2 • 9 months
|
|
Nervous system disorders
Tremor
|
25.0%
1/4 • Number of events 1 • 9 months
|
|
Vascular disorders
DVT
|
25.0%
1/4 • Number of events 1 • 9 months
|
|
Nervous system disorders
Mood alteration
|
50.0%
2/4 • Number of events 2 • 9 months
|
|
General disorders
Pain
|
25.0%
1/4 • Number of events 3 • 9 months
|
|
General disorders
Edema
|
25.0%
1/4 • Number of events 1 • 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acanthoma
|
25.0%
1/4 • Number of events 1 • 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place