Trial Outcomes & Findings for Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): DNA Microarray Gene Expression Analysis (NCT NCT00001586)
NCT ID: NCT00001586
Last Updated: 2013-05-15
Results Overview
Changes in lymphocyte gene expression was measured by deoxyribonucleic acid (DNA) microarray analysis of circulating leukemic cells after completion of study treatment. A change in expression is defined as a \>50% increase in circulating leukemic cells or a 30% decrease in circulating leukemic cells.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
105 participants
Primary outcome timeframe
6 hours post treatment, and 24 hours post treatment
Results posted on
2013-05-15
Participant Flow
Participant milestones
| Measure |
Intermediate-high Risk B-Cell Pts
Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m\^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m\^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
|
Low-Intermediate Risk B-Cell Pts
Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered. Eligible to donate cells.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
56
|
|
Overall Study
COMPLETED
|
49
|
56
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): DNA Microarray Gene Expression Analysis
Baseline characteristics by cohort
| Measure |
Intermediate-high Risk B-Cell Pts
n=49 Participants
Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m\^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m\^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
|
Low-Intermediate Risk B-Cell Pts
n=56 Participants
Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered.
|
Total
n=105 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
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age Continuous
|
56.2 years
STANDARD_DEVIATION 9.34 • n=5 Participants
|
58.42 years
STANDARD_DEVIATION 11.32 • n=7 Participants
|
57.98 years
STANDARD_DEVIATION 11.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
94 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
56 participants
n=7 Participants
|
105 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 hours post treatment, and 24 hours post treatmentPopulation: There were only 12 patients analyzed for various reasons such as timing of treatment, ability to collect samples, and viability of samples.
Changes in lymphocyte gene expression was measured by deoxyribonucleic acid (DNA) microarray analysis of circulating leukemic cells after completion of study treatment. A change in expression is defined as a \>50% increase in circulating leukemic cells or a 30% decrease in circulating leukemic cells.
Outcome measures
| Measure |
Intermediate-high Risk B-Cell Pts
n=12 Participants
Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m\^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m\^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
|
Low-Intermediate Risk B-Cell Pts
Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered.
|
|---|---|---|
|
Change in Gene Expression Post Chemo
6 hours post treatment (e.g. ># cells)
|
30 Percent change in cells
|
—
|
|
Change in Gene Expression Post Chemo
24 hours post treatment (e.g. > # cells)
|
50 Percent change in cells
|
—
|
SECONDARY outcome
Timeframe: 13 years, 10.5 monthsPopulation: The low-intermediate risk patients received no treatment so their tissue/blood was not analyzed for change.
Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Intermediate-high Risk B-Cell Pts
n=49 Participants
Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m\^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m\^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
|
Low-Intermediate Risk B-Cell Pts
Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
18 Participants
|
—
|
Adverse Events
Intermediate-high Risk B-Cell Pts
Serious events: 19 serious events
Other events: 18 other events
Deaths: 0 deaths
Low-Intermediate Risk B-Cell Pts
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intermediate-high Risk B-Cell Pts
n=49 participants at risk
Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m\^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m\^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
|
Low-Intermediate Risk B-Cell Pts
Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered.
|
|---|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
4.1%
2/49 • Number of events 3
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
2.0%
1/49 • Number of events 1
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Immune system disorders
Autoimmune reaction
|
8.2%
4/49 • Number of events 4
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
16.3%
8/49 • Number of events 11
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Gastrointestinal disorders
Hemorrhage, GI::Oral cavity
|
2.0%
1/49 • Number of events 1
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory::Nose
|
2.0%
1/49 • Number of events 1
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Infections and infestations
Infection
|
4.1%
2/49 • Number of events 2
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
|
2.0%
1/49 • Number of events 1
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::External ear (otitis externa)
|
2.0%
1/49 • Number of events 1
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
|
2.0%
1/49 • Number of events 1
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
|
2.0%
1/49 • Number of events 1
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS
|
2.0%
1/49 • Number of events 1
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
38.8%
19/49 • Number of events 31
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
36.7%
18/49 • Number of events 36
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Nervous system disorders
Pain::Neuralgia/peripheral nerve
|
2.0%
1/49 • Number of events 1
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Blood and lymphatic system disorders
Platelets
|
4.1%
2/49 • Number of events 2
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
2.0%
1/49 • Number of events 1
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
6.1%
3/49 • Number of events 3
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
2.0%
1/49 • Number of events 1
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
Other adverse events
| Measure |
Intermediate-high Risk B-Cell Pts
n=49 participants at risk
Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m\^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m\^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
|
Low-Intermediate Risk B-Cell Pts
Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered.
|
|---|---|---|
|
Hepatobiliary disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
20.4%
10/49 • Number of events 11
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Immune system disorders
Rhinorrhea
|
30.6%
15/49 • Number of events 25
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Hepatobiliary disorders
Alkaline phosphatase
|
6.1%
3/49 • Number of events 3
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
6.1%
3/49 • Number of events 4
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
10.2%
5/49 • Number of events 6
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Gastrointestinal disorders
Anorexia
|
12.2%
6/49 • Number of events 6
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Immune system disorders
Autoimmune reaction
|
6.1%
3/49 • Number of events 3
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Hepatobiliary disorders
Bilirubin (hyperbilirubinemia)
|
8.2%
4/49 • Number of events 6
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
4.1%
2/49 • Number of events 2
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Cardiac disorders
Cardiac arrhythmia - Other, Specify, unknown
|
2.0%
1/49 • Number of events 1
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Psychiatric disorders
Confusion
|
2.0%
1/49 • Number of events 1
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.2%
4/49 • Number of events 5
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Renal and urinary disorders
Creatinine
|
2.0%
1/49 • Number of events 4
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
10.2%
5/49 • Number of events 6
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Nervous system disorders
Dizziness
|
8.2%
4/49 • Number of events 5
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
6.1%
3/49 • Number of events 3
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
General disorders
Edema: limb
|
2.0%
1/49 • Number of events 1
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
10.2%
5/49 • Number of events 5
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Infections and infestations
Febrile neutropenia
|
6.1%
3/49 • Number of events 3
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
16.3%
8/49 • Number of events 9
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hyperglycemia)
|
24.5%
12/49 • Number of events 17
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
8.2%
4/49 • Number of events 4
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
2.0%
1/49 • Number of events 1
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Blood and lymphatic system disorders
Hemorrhage, GI::Oral cavity
|
2.0%
1/49 • Number of events 1
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Blood and lymphatic system disorders
Hemorrhage, pulmonary/upper respiratory: Nose
|
2.0%
1/49 • Number of events 1
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Blood and lymphatic system disorders
Transfusion
|
6.1%
3/49 • Number of events 3
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Nervous system disorders
Syncope
|
2.0%
1/49 • Number of events 1
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Infections and infestations
Infection w/neutropenia
|
2.0%
1/49 • Number of events 1
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Blood and lymphatic system disorders
Hemoptysis
|
4.1%
2/49 • Number of events 2
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
|
2.0%
1/49 • Number of events 1
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper aerodigestive NOS
|
4.1%
2/49 • Number of events 2
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS
|
4.1%
2/49 • Number of events 2
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Infections and infestations
Infection with unknown ANC::Skin (cellulites)
|
2.0%
1/49 • Number of events 1
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Nervous system disorders
Insomnia
|
4.1%
2/49 • Number of events 2
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
32.7%
16/49 • Number of events 55
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
26.5%
13/49 • Number of events 29
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
10.2%
5/49 • Number of events 5
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
6.1%
3/49 • Number of events 4
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Nervous system disorders
Mood alteration::Anxiety
|
2.0%
1/49 • Number of events 1
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)::Oral cavity
|
4.1%
2/49 • Number of events 2
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Gastrointestinal disorders
Nausea
|
18.4%
9/49 • Number of events 16
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Nervous system disorders
Neuropathy: sensory
|
2.0%
1/49 • Number of events 1
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
36.7%
18/49 • Number of events 55
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
4.1%
2/49 • Number of events 2
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Reproductive system and breast disorders
Pain::Abdomen NOS
|
4.1%
2/49 • Number of events 2
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain::Bone
|
6.1%
3/49 • Number of events 5
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Cardiac disorders
Pain::Chest wall
|
2.0%
1/49 • Number of events 1
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Blood and lymphatic system disorders
Platelets
|
36.7%
18/49 • Number of events 45
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
General disorders
Bone pain
|
8.2%
4/49 • Number of events 6
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
2.0%
1/49 • Number of events 1
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
—
0/0
The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.
|
Additional Information
Wyndham H. Wilson, M.D.
National Cancer Institute, National Institutes of Health
Phone: 301-435-2415
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place