Trial Outcomes & Findings for Rituximab and GM-CSF in Treating Patients With Newly Diagnosed Follicular B-Cell Lymphoma (NCT NCT00411086)
NCT ID: NCT00411086
Last Updated: 2017-12-05
Results Overview
Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities \[e.g., lactate dehydrogenase (LDH)\] definitely assignable to NHL. Response and progression evaluated using the International Criteria proposed in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
12 weeks (3 months)
Results posted on
2017-12-05
Participant Flow
Recruitment period: December 2006 and May 2009. All recruitment was done in medical clinics in participating Community Clinical Oncology Program sites.
Participant milestones
| Measure |
Rituximab + GM-CSF
Rituximab 375 mg/m\^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
52
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rituximab and GM-CSF in Treating Patients With Newly Diagnosed Follicular B-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Rituximab + GM-CSF
n=52 Participants
Rituximab 375 mg/m\^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
|
|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks (3 months)Population: Response includes unconfirmed CRs.
Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities \[e.g., lactate dehydrogenase (LDH)\] definitely assignable to NHL. Response and progression evaluated using the International Criteria proposed in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas.
Outcome measures
| Measure |
Rituximab + GM-CSF
n=52 Participants
Rituximab 375 mg/m\^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
|
|---|---|
|
Complete Response Rate
|
23 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsPFS is defined as the duration of time from start of treatment to time of progression; and, for PFS time calculated from chemo start date to progression date or death date, whichever happened first. Patients were censored at the last follow-up date if neither progression nor death occurred. Response and progression evaluated using the International Criteria proposed in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas. The Kaplan-Meier method was used for time-to-event analysis including PFS.
Outcome measures
| Measure |
Rituximab + GM-CSF
n=52 Participants
Rituximab 375 mg/m\^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
|
|---|---|
|
Median Progression-Free Survival (PFS)
|
25 Months
Interval 15.3 to 59.9
|
SECONDARY outcome
Timeframe: 3 MonthsOS defined as percentage of participants alive at a certain period following start of chemotherapy treatment.
Outcome measures
| Measure |
Rituximab + GM-CSF
n=52 Participants
Rituximab 375 mg/m\^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
|
|---|---|
|
Overall Response (OR) Rate
|
69 percentage of participants
|
Adverse Events
Rituximab + GM-CSF
Serious events: 10 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rituximab + GM-CSF
n=52 participants at risk
Rituximab 375 mg/m\^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
15.4%
8/52 • Adverse events collected through 8 week treatment period.
|
|
General disorders
Pain
|
5.8%
3/52 • Adverse events collected through 8 week treatment period.
|
|
General disorders
Fatigue/weakness
|
3.8%
2/52 • Adverse events collected through 8 week treatment period.
|
|
Eye disorders
Blurred vision
|
1.9%
1/52 • Adverse events collected through 8 week treatment period.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.9%
1/52 • Adverse events collected through 8 week treatment period.
|
|
Injury, poisoning and procedural complications
Infusion reaction
|
1.9%
1/52 • Adverse events collected through 8 week treatment period.
|
|
Nervous system disorders
Central Nervous System (CNS) ischemia
|
1.9%
1/52 • Adverse events collected through 8 week treatment period.
|
Other adverse events
| Measure |
Rituximab + GM-CSF
n=52 participants at risk
Rituximab 375 mg/m\^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
|
|---|---|
|
Immune system disorders
Allergic Reaction
|
1.9%
1/52 • Number of events 1 • Adverse events collected through 8 week treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
3.8%
2/52 • Number of events 2 • Adverse events collected through 8 week treatment period.
|
|
Immune system disorders
Allergy/Immunology, Other: Mild allergy symptoms
|
3.8%
2/52 • Number of events 2 • Adverse events collected through 8 week treatment period.
|
|
Eye disorders
Blurred Vision
|
9.6%
5/52 • Number of events 5 • Adverse events collected through 8 week treatment period.
|
|
Cardiac disorders
Cardiac General
|
1.9%
1/52 • Number of events 1 • Adverse events collected through 8 week treatment period.
|
|
Cardiac disorders
Chest Tightness
|
3.8%
2/52 • Number of events 2 • Adverse events collected through 8 week treatment period.
|
|
Psychiatric disorders
Confusion
|
1.9%
1/52 • Number of events 1 • Adverse events collected through 8 week treatment period.
|
|
Gastrointestinal disorders
Constipation
|
19.2%
10/52 • Number of events 10 • Adverse events collected through 8 week treatment period.
|
|
General disorders
Constitutional Symptoms
|
1.9%
1/52 • Number of events 1 • Adverse events collected through 8 week treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
2/52 • Number of events 2 • Adverse events collected through 8 week treatment period.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin
|
3.8%
2/52 • Number of events 2 • Adverse events collected through 8 week treatment period.
|
|
Gastrointestinal disorders
Diarrhea
|
15.4%
8/52 • Number of events 8 • Adverse events collected through 8 week treatment period.
|
|
Nervous system disorders
Dizziness
|
17.3%
9/52 • Number of events 9 • Adverse events collected through 8 week treatment period.
|
|
Gastrointestinal disorders
Dysphagia
|
1.9%
1/52 • Number of events 1 • Adverse events collected through 8 week treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.3%
9/52 • Number of events 9 • Adverse events collected through 8 week treatment period.
|
|
Skin and subcutaneous tissue disorders
Edema, Facial
|
7.7%
4/52 • Number of events 4 • Adverse events collected through 8 week treatment period.
|
|
Skin and subcutaneous tissue disorders
Edema: Head And Neck
|
3.8%
2/52 • Number of events 2 • Adverse events collected through 8 week treatment period.
|
|
Skin and subcutaneous tissue disorders
Edema: Limb
|
9.6%
5/52 • Number of events 5 • Adverse events collected through 8 week treatment period.
|
|
General disorders
Fatigue
|
32.7%
17/52 • Number of events 17 • Adverse events collected through 8 week treatment period.
|
|
General disorders
Fever Without Neutropenia
|
11.5%
6/52 • Number of events 6 • Adverse events collected through 8 week treatment period.
|
|
Vascular disorders
Flushing
|
1.9%
1/52 • Number of events 1 • Adverse events collected through 8 week treatment period.
|
|
Gastrointestinal disorders
Gastrointestinal, Other: Gastritis or related symptoms
|
7.7%
4/52 • Number of events 4 • Adverse events collected through 8 week treatment period.
|
|
Investigations
Hemoglobin increased
|
1.9%
1/52 • Number of events 1 • Adverse events collected through 8 week treatment period.
|
|
Vascular disorders
Hypertension
|
1.9%
1/52 • Number of events 1 • Adverse events collected through 8 week treatment period.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
1.9%
1/52 • Number of events 1 • Adverse events collected through 8 week treatment period.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.8%
2/52 • Number of events 2 • Adverse events collected through 8 week treatment period.
|
|
Metabolism and nutrition disorders
Hypotension
|
1.9%
1/52 • Number of events 1 • Adverse events collected through 8 week treatment period.
|
|
Infections and infestations
Infection (Other)
|
1.9%
1/52 • Number of events 1 • Adverse events collected through 8 week treatment period.
|
|
Injury, poisoning and procedural complications
Injection Site Reaction
|
13.5%
7/52 • Number of events 7 • Adverse events collected through 8 week treatment period.
|
|
Psychiatric disorders
Insomnia
|
1.9%
1/52 • Number of events 1 • Adverse events collected through 8 week treatment period.
|
|
Blood and lymphatic system disorders
Leukocytes Change/Leukocytosis
|
1.9%
1/52 • Number of events 1 • Adverse events collected through 8 week treatment period.
|
|
Psychiatric disorders
Memory Impairment
|
11.5%
6/52 • Number of events 6 • Adverse events collected through 8 week treatment period.
|
|
Psychiatric disorders
Mental Status
|
1.9%
1/52 • Number of events 1 • Adverse events collected through 8 week treatment period.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory, Other: change in blood levels
|
1.9%
1/52 • Number of events 1 • Adverse events collected through 8 week treatment period.
|
|
Nervous system disorders
Mood Alteration, not interfering with function
|
3.8%
2/52 • Number of events 2 • Adverse events collected through 8 week treatment period.
|
|
Nervous system disorders
Mood Alteration
|
1.9%
1/52 • Number of events 1 • Adverse events collected through 8 week treatment period.
|
|
Gastrointestinal disorders
Mucositis
|
11.5%
6/52 • Number of events 6 • Adverse events collected through 8 week treatment period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, Other: pain
|
3.8%
2/52 • Number of events 2 • Adverse events collected through 8 week treatment period.
|
|
Gastrointestinal disorders
Nausea
|
23.1%
12/52 • Number of events 12 • Adverse events collected through 8 week treatment period.
|
|
Nervous system disorders
Neurology (Other)
|
3.8%
2/52 • Number of events 2 • Adverse events collected through 8 week treatment period.
|
|
Nervous system disorders
Neuropathy: Motor
|
3.8%
2/52 • Number of events 2 • Adverse events collected through 8 week treatment period.
|
|
Nervous system disorders
Neuropathy: Sensory
|
9.6%
5/52 • Number of events 5 • Adverse events collected through 8 week treatment period.
|
|
Eye disorders
Ocular Surface Discomfort
|
1.9%
1/52 • Number of events 1 • Adverse events collected through 8 week treatment period.
|
|
Eye disorders
Ocular/Visual
|
5.8%
3/52 • Number of events 3 • Adverse events collected through 8 week treatment period.
|
|
Gastrointestinal disorders
Pain (Abdomen Nos)
|
3.8%
2/52 • Number of events 2 • Adverse events collected through 8 week treatment period.
|
|
Musculoskeletal and connective tissue disorders
Pain (Back)
|
3.8%
2/52 • Number of events 2 • Adverse events collected through 8 week treatment period.
|
|
Musculoskeletal and connective tissue disorders
Pain (Bone)
|
3.8%
2/52 • Number of events 2 • Adverse events collected through 8 week treatment period.
|
|
General disorders
Pain (Chest Wall)
|
3.8%
2/52 • Number of events 2 • Adverse events collected through 8 week treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pain (Chest/Thorax)
|
3.8%
2/52 • Number of events 2 • Adverse events collected through 8 week treatment period.
|
|
Musculoskeletal and connective tissue disorders
Pain (Extremity-Limb)
|
1.9%
1/52 • Number of events 1 • Adverse events collected through 8 week treatment period.
|
|
General disorders
Pain (Head/Headache)
|
13.5%
7/52 • Number of events 7 • Adverse events collected through 8 week treatment period.
|
|
Musculoskeletal and connective tissue disorders
Pain (Muscle)
|
25.0%
13/52 • Number of events 13 • Adverse events collected through 8 week treatment period.
|
|
Musculoskeletal and connective tissue disorders
Pain (Neck)
|
3.8%
2/52 • Number of events 2 • Adverse events collected through 8 week treatment period.
|
|
General disorders
Pain (Nos)
|
3.8%
2/52 • Number of events 2 • Adverse events collected through 8 week treatment period.
|
|
General disorders
Pain (Other)
|
5.8%
3/52 • Number of events 3 • Adverse events collected through 8 week treatment period.
|
|
Reproductive system and breast disorders
Pain (Scrotum)
|
1.9%
1/52 • Number of events 1 • Adverse events collected through 8 week treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pain (Throat/Pharynx)
|
5.8%
3/52 • Number of events 3 • Adverse events collected through 8 week treatment period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.8%
2/52 • Number of events 2 • Adverse events collected through 8 week treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary (Other)
|
1.9%
1/52 • Number of events 1 • Adverse events collected through 8 week treatment period.
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
3.8%
2/52 • Number of events 2 • Adverse events collected through 8 week treatment period.
|
|
Eye disorders
Redness Of Eyes
|
11.5%
6/52 • Number of events 6 • Adverse events collected through 8 week treatment period.
|
|
General disorders
Rigors/Chills
|
23.1%
12/52 • Number of events 12 • Adverse events collected through 8 week treatment period.
|
|
Cardiac disorders
Sinus Bradycardia
|
1.9%
1/52 • Number of events 1 • Adverse events collected through 8 week treatment period.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
1.9%
1/52 • Number of events 1 • Adverse events collected through 8 week treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
3.8%
2/52 • Number of events 2 • Adverse events collected through 8 week treatment period.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
5.8%
3/52 • Number of events 3 • Adverse events collected through 8 week treatment period.
|
|
Ear and labyrinth disorders
Vertigo
|
1.9%
1/52 • Number of events 1 • Adverse events collected through 8 week treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes
|
1.9%
1/52 • Number of events 1 • Adverse events collected through 8 week treatment period.
|
|
Gastrointestinal disorders
Vomiting
|
11.5%
6/52 • Number of events 6 • Adverse events collected through 8 week treatment period.
|
|
Eye disorders
Watery Eye
|
7.7%
4/52 • Number of events 4 • Adverse events collected through 8 week treatment period.
|
Additional Information
Clinical Research Operations Team, Office of VP Clinical Research
UT MD Anderson Cancer Center
Phone: 713-792-7734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place