Trial Outcomes & Findings for Rituximab and Dexamethasone in Treating Patients With Low-Grade Non-Hodgkin Lymphoma (NCT NCT00244855)
NCT ID: NCT00244855
Last Updated: 2017-05-22
Results Overview
Survival without measurable progression of lymphoma estimated according to the Kaplan-Meier method
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
At 3 and 6 months after enrollment
Results posted on
2017-05-22
Participant Flow
Participant milestones
| Measure |
No Previous Treatment
Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
pharmacological study: Correlative studies
rituximab: Given IV
dexamethasone: Given IV
laboratory biomarker analysis: Correlative studies
|
Previous Treatment
Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
pharmacological study: Correlative studies
rituximab: Given IV
dexamethasone: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
25
|
|
Overall Study
COMPLETED
|
7
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
No Previous Treatment
Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
pharmacological study: Correlative studies
rituximab: Given IV
dexamethasone: Given IV
laboratory biomarker analysis: Correlative studies
|
Previous Treatment
Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
pharmacological study: Correlative studies
rituximab: Given IV
dexamethasone: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Rituximab and Dexamethasone in Treating Patients With Low-Grade Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Previous Treatment
n=7 Participants
Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
pharmacological study: Correlative studies
rituximab: Given IV
dexamethasone: Given IV
laboratory biomarker analysis: Correlative studies
|
No Previous Treatment
n=25 Participants
Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
pharmacological study: Correlative studies
rituximab: Given IV
dexamethasone: Given IV
laboratory biomarker analysis: Correlative studies
|
Total
n=32 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
|
14 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Continuous
|
67 years
n=5 Participants
|
64 years
n=7 Participants
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
6 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
29 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
|
7 participants
n=5 Participants
|
25 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 3 and 6 months after enrollmentSurvival without measurable progression of lymphoma estimated according to the Kaplan-Meier method
Outcome measures
| Measure |
Previous Treatment
n=7 Participants
Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
pharmacological study: Correlative studies
rituximab: Given IV
dexamethasone: Given IV
laboratory biomarker analysis: Correlative studies
|
No Previous Treatment
n=25 Participants
Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
pharmacological study: Correlative studies
rituximab: Given IV
dexamethasone: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Progression-free Survival
At 3 months after enrollment
|
92 Kaplan-Meier estimated % of patients
Interval 81.0 to 100.0
|
71 Kaplan-Meier estimated % of patients
Interval 45.0 to 100.0
|
|
Progression-free Survival
At 6 months after enrollment
|
83 Kaplan-Meier estimated % of patients
Interval 70.0 to 100.0
|
71 Kaplan-Meier estimated % of patients
Interval 45.0 to 100.0
|
SECONDARY outcome
Timeframe: At 6 months, 12 months and 24 months after enrollmentPercentage of patients remaining alive estimated according to the Kaplan-Meier method
Outcome measures
| Measure |
Previous Treatment
n=7 Participants
Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
pharmacological study: Correlative studies
rituximab: Given IV
dexamethasone: Given IV
laboratory biomarker analysis: Correlative studies
|
No Previous Treatment
n=25 Participants
Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
pharmacological study: Correlative studies
rituximab: Given IV
dexamethasone: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Survival
At 6 months
|
96 Kaplan-Meier estimated % of patients
Interval 88.0 to 100.0
|
100 Kaplan-Meier estimated % of patients
Interval 100.0 to 100.0
|
|
Survival
At 12 months
|
96 Kaplan-Meier estimated % of patients
Interval 88.0 to 100.0
|
100 Kaplan-Meier estimated % of patients
Interval 100.0 to 100.0
|
|
Survival
At 24 months
|
91 Kaplan-Meier estimated % of patients
Interval 80.0 to 100.0
|
67 Kaplan-Meier estimated % of patients
Interval 38.0 to 100.0
|
Adverse Events
Previous Treatment
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
No Previous Treatment
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Previous Treatment
n=7 participants at risk
Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
pharmacological study: Correlative studies
rituximab: Given IV
dexamethasone: Given IV
laboratory biomarker analysis: Correlative studies
|
No Previous Treatment
n=25 participants at risk
Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
pharmacological study: Correlative studies
rituximab: Given IV
dexamethasone: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Cardiac disorders
Vasovagal episode
|
14.3%
1/7 • 6 months
|
0.00%
0/25 • 6 months
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • 6 months
|
0.00%
0/25 • 6 months
|
|
Cardiac disorders
Hypotension
|
14.3%
1/7 • 6 months
|
4.0%
1/25 • 6 months
|
|
Immune system disorders
Cytokine release syndrome
|
14.3%
1/7 • 6 months
|
4.0%
1/25 • 6 months
|
|
Immune system disorders
Lymphopenia
|
28.6%
2/7 • 6 months
|
8.0%
2/25 • 6 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
1/7 • 6 months
|
4.0%
1/25 • 6 months
|
|
Vascular disorders
Thrombosis
|
14.3%
1/7 • 6 months
|
0.00%
0/25 • 6 months
|
|
Immune system disorders
Urticaria
|
14.3%
1/7 • 6 months
|
4.0%
1/25 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/7 • 6 months
|
4.0%
1/25 • 6 months
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/7 • 6 months
|
8.0%
2/25 • 6 months
|
|
General disorders
Fatigue
|
0.00%
0/7 • 6 months
|
4.0%
1/25 • 6 months
|
|
Infections and infestations
Penile infection
|
14.3%
1/7 • 6 months
|
0.00%
0/25 • 6 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • 6 months
|
12.0%
3/25 • 6 months
|
|
Nervous system disorders
Confusion
|
0.00%
0/7 • 6 months
|
4.0%
1/25 • 6 months
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/7 • 6 months
|
4.0%
1/25 • 6 months
|
|
General disorders
Pain
|
14.3%
1/7 • 6 months
|
16.0%
4/25 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
14.3%
1/7 • 6 months
|
0.00%
0/25 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • 6 months
|
0.00%
0/25 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • 6 months
|
0.00%
0/25 • 6 months
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/7 • 6 months
|
4.0%
1/25 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • 6 months
|
0.00%
0/25 • 6 months
|
|
General disorders
Fever
|
14.3%
1/7 • 6 months
|
0.00%
0/25 • 6 months
|
|
General disorders
Sweating
|
14.3%
1/7 • 6 months
|
0.00%
0/25 • 6 months
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/7 • 6 months
|
4.0%
1/25 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7 • 6 months
|
4.0%
1/25 • 6 months
|
|
Endocrine disorders
Hyperglycemia
|
0.00%
0/7 • 6 months
|
4.0%
1/25 • 6 months
|
|
Endocrine disorders
Hypoglycemia
|
0.00%
0/7 • 6 months
|
4.0%
1/25 • 6 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/7 • 6 months
|
4.0%
1/25 • 6 months
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
0.00%
0/7 • 6 months
|
4.0%
1/25 • 6 months
|
Additional Information
Dr. David Maloney
Fred Hutchinson Cancer Research Center
Phone: 206-667-5616
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place