Trial Outcomes & Findings for Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma (NCT NCT00072449)
NCT ID: NCT00072449
Last Updated: 2013-08-28
Results Overview
it at any time point patient progresses no more scans are required, patient is off study
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
1 month, 2 months and then q3months
Results posted on
2013-08-28
Participant Flow
Participant milestones
| Measure |
Rituximab Monotherapy
Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma
Baseline characteristics by cohort
| Measure |
Rituximab Monotherapy
n=12 Participants
Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
|
|---|---|
|
Age Continuous
age, years
|
64 years
FULL_RANGE 31-81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Karnofsky Performance Status Scale
|
85 Score
n=5 Participants
|
|
Mini-Mental State Examination (MMSE)
|
29 Score
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month, 2 months and then q3monthsit at any time point patient progresses no more scans are required, patient is off study
Outcome measures
| Measure |
Rituximab Monotherapy
n=11 Participants
Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
|
|---|---|
|
Radiographic Response
|
4 participants
|
SECONDARY outcome
Timeframe: pt had MRI q3monthspt had MRI every 3 months
Outcome measures
| Measure |
Rituximab Monotherapy
n=12 Participants
Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
|
|---|---|
|
Progression-free Survival
|
57 days
Interval 29.0 to 175.0
|
SECONDARY outcome
Timeframe: 47 monthssurvival was evaluated q 2months
Outcome measures
| Measure |
Rituximab Monotherapy
n=12 Participants
Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
|
|---|---|
|
Overall Survival
|
20.9 months
Interval 2.9 to 47.0
|
SECONDARY outcome
Timeframe: 8 weeks - 2 cyclespatients only received drug for 8 weeks
Outcome measures
| Measure |
Rituximab Monotherapy
n=12 Participants
Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
|
|---|---|
|
Toxicity
|
4 related episodes
|
Adverse Events
Rituximab Monotherapy
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rituximab Monotherapy
n=12 participants at risk
Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
|
|---|---|
|
Infections and infestations
infection-sepsis
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
Other adverse events
| Measure |
Rituximab Monotherapy
n=12 participants at risk
Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
|
|---|---|
|
Endocrine disorders
Adrenal insufficiency
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Infections and infestations
"Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)"
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
2/12 • Number of events 2 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Nervous system disorders
Ataxia (incoordination)
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Gastrointestinal disorders
Colitis
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Psychiatric disorders
Confusion
|
50.0%
6/12 • Number of events 7 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Gastrointestinal disorders
Constipation
|
16.7%
2/12 • Number of events 2 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
General disorders
"Constitutional Symptoms - Other (Specify, cold
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • Number of events 2 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
16.7%
2/12 • Number of events 2 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
General disorders
Edema: limb
|
33.3%
4/12 • Number of events 6 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
General disorders
"Fatigue (asthenia, lethargy, malaise)"
|
75.0%
9/12 • Number of events 9 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
General disorders
"Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)"
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Gastrointestinal disorders
Gastrointestinal-other - mouth sores
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Vascular disorders
Hypotension
|
25.0%
3/12 • Number of events 3 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Infections and infestations
"Infection - Other (Specify, __)" - oral thrush
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Infections and infestations
"Infection - Other (Specify, __)" - shingles
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Nervous system disorders
Memory impairment
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Psychiatric disorders
Mood alteration - Anxiety
|
25.0%
3/12 • Number of events 3 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Psychiatric disorders
Mood alteration - Depression
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Musculoskeletal and connective tissue disorders
"Muscle weakness, generalized or specific area (not due to neuropathy) - Left-sided"
|
33.3%
4/12 • Number of events 6 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • Number of events 2 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Eye disorders
Neuropathy: cranial - CN II Vision
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Nervous system disorders
Neuropathy: motor
|
16.7%
2/12 • Number of events 2 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Nervous system disorders
Neuropathy: sensory
|
16.7%
2/12 • Number of events 3 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Eye disorders
Ophthalmoplegia/diplopia (double vision)
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Injury, poisoning and procedural complications
Pain - Back
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Nervous system disorders
Pain - Head/headache
|
33.3%
4/12 • Number of events 4 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Musculoskeletal and connective tissue disorders
Pain - Miuscle
|
16.7%
2/12 • Number of events 2 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Cardiac disorders
Palpitations
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Metabolism and nutrition disorders
"Phosphate, serum-low (hypophosphatemia)"
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Investigations
Platelets
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
16.7%
2/12 • Number of events 2 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Respiratory, thoracic and mediastinal disorders
"Pulmonary/Upper Respiratory - Other (Specify, __)"
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
General disorders
Rigors/chills
|
25.0%
3/12 • Number of events 3 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Nervous system disorders
seizure
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Nervous system disorders
somnolence
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Nervous system disorders
speech impairment
|
16.7%
2/12 • Number of events 2 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Vascular disorders
thrombosis
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Ear and labyrinth disorders
tinnitus
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Nervous system disorders
tremor
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Eye disorders
vision blurred
|
25.0%
3/12 • Number of events 3 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Gastrointestinal disorders
vomiting
|
16.7%
2/12 • Number of events 2 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Investigations
Alkaline phosphatase
|
16.7%
2/12 • Number of events 2 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Investigations
Creatinine
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Investigations
hemoglobin
|
50.0%
6/12 • Number of events 21 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
4/12 • Number of events 9 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
75.0%
9/12 • Number of events 13 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
2/12 • Number of events 2 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
2/12 • Number of events 2 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Infections and infestations
platelets
|
33.3%
4/12 • Number of events 8 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Infections and infestations
aspartate aminotransferase SGOT
|
25.0%
3/12 • Number of events 3 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Investigations
alanine aminotransferase SGPT
|
25.0%
3/12 • Number of events 5 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Investigations
total bilirubin
|
8.3%
1/12 • Number of events 1 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
|
Blood and lymphatic system disorders
white blood count
|
16.7%
2/12 • Number of events 8 • While on active treatment and for on month after treatment, which meant 8 weeks of active treatment and 1 month follow-up.
Note that not all AEs are related to treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place