Trial Outcomes & Findings for Sunitinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (NCT NCT00398112)
NCT ID: NCT00398112
Last Updated: 2014-05-14
Results Overview
National Cancer Institute working group criteria (NCIWG) was used to assess response.\> * CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate \& biopsy\> * PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, \>100000/μL platelets, \>11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions
COMPLETED
PHASE2
18 participants
Duration of Treatment (up to 12 cycles)
2014-05-14
Participant Flow
Between August 2007 and December 2008, 18 participants were recruited.
All participants were eligible and included in all analyses.
Participant milestones
| Measure |
Sunitinib Malate
Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Sunitinib Malate
Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Disease progression
|
9
|
|
Overall Study
Alternative treatment
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Sunitinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Baseline characteristics by cohort
| Measure |
Sunitinib Malate
n=18 Participants
Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
67.5 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=93 Participants
|
|
Fluorescence In Situ Hybridization (FISH) Abnormalities
del 17p13
|
6 participants
n=93 Participants
|
|
Fluorescence In Situ Hybridization (FISH) Abnormalities
del 11q23
|
1 participants
n=93 Participants
|
|
Fluorescence In Situ Hybridization (FISH) Abnormalities
Trisomy 12
|
5 participants
n=93 Participants
|
|
Fluorescence In Situ Hybridization (FISH) Abnormalities
del 13q14
|
2 participants
n=93 Participants
|
|
Fluorescence In Situ Hybridization (FISH) Abnormalities
Normal
|
4 participants
n=93 Participants
|
|
Rai Stage
Low (Rai 0)
|
0 participants
n=93 Participants
|
|
Rai Stage
Intermediate (Rai I-II)
|
8 participants
n=93 Participants
|
|
Rai Stage
High (Rai III-IV)
|
10 participants
n=93 Participants
|
|
ZAP-70 Status
Positive
|
10 participants
n=93 Participants
|
|
ZAP-70 Status
Negative
|
8 participants
n=93 Participants
|
|
CD38 Status
Positive
|
9 participants
n=93 Participants
|
|
CD38 Status
Negative
|
9 participants
n=93 Participants
|
|
Immunoglobulin Variable Heavy Chain (IGVH) Mutation Status
Unmutated
|
1 participants
n=93 Participants
|
|
Immunoglobulin Variable Heavy Chain (IGVH) Mutation Status
Mutated
|
0 participants
n=93 Participants
|
|
Immunoglobulin Variable Heavy Chain (IGVH) Mutation Status
Missing
|
17 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Duration of Treatment (up to 12 cycles)National Cancer Institute working group criteria (NCIWG) was used to assess response.\> * CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate \& biopsy\> * PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, \>100000/μL platelets, \>11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions
Outcome measures
| Measure |
Sunitinib Malate
n=18 Participants
Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Participants With a Confirmed Response [Complete Response (CR) and Partial Response (PR)] on 2 Consecutive Evaluations at Least 4 Weeks Apart
|
0 participants
|
SECONDARY outcome
Timeframe: Duration of Treatment (up to 12 cycles)Population: No participants had a confirmed response, there for this analysis cannot be completed.
Complete response is described in the primary outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Duration of study (up to 2 years)Survival time was defined as the time from registration to death due to any cause. The distribution of survival time was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Sunitinib Malate
n=18 Participants
Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Survival Time
|
20.6 Months
Interval 8.0 to
The upper limit of 95% confidence interval of median survival time has not been attained because of the insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Duration of study (up to 2 years)Progression-free survival (PFS) was defined as the time from registration to progression or death due to any cause. The distribution of PFS was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Sunitinib Malate
n=18 Participants
Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Progression-free Survival
|
2.7 months
Interval 1.8 to 4.6
|
SECONDARY outcome
Timeframe: Duration on study (up 2 years)Population: No participants had a confirmed response, there for this analysis cannot be completed.
Duration of response was calculated from the documentation (date) of first response (CR or PR) until the date of progression or last follow-up in the subset of patients who responded. The median duration of response with 95%CI was estimated using the Kaplan Meier method
Outcome measures
Outcome data not reported
Adverse Events
Sunitinib Malate
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sunitinib Malate
n=18 participants at risk
Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
83.3%
15/18 • Number of events 27
|
|
Eye disorders
Vision blurred
|
5.6%
1/18 • Number of events 1
|
|
Eye disorders
Watering eyes
|
5.6%
1/18 • Number of events 9
|
|
Gastrointestinal disorders
Abdominal distension
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
38.9%
7/18 • Number of events 7
|
|
Gastrointestinal disorders
Anal mucositis
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
16.7%
3/18 • Number of events 11
|
|
Gastrointestinal disorders
Diarrhea
|
44.4%
8/18 • Number of events 18
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
2/18 • Number of events 9
|
|
Gastrointestinal disorders
Dyspepsia
|
27.8%
5/18 • Number of events 10
|
|
Gastrointestinal disorders
Esophageal mucositis
|
27.8%
5/18 • Number of events 11
|
|
Gastrointestinal disorders
Gastric mucositis
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
55.6%
10/18 • Number of events 16
|
|
Gastrointestinal disorders
Nausea
|
38.9%
7/18 • Number of events 14
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
3/18 • Number of events 6
|
|
General disorders
Chest pain
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Edema limbs
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Fatigue
|
88.9%
16/18 • Number of events 40
|
|
General disorders
Localized edema
|
11.1%
2/18 • Number of events 5
|
|
Infections and infestations
Anal infection
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Anorectal infection
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
5.6%
1/18 • Number of events 2
|
|
Infections and infestations
Infectious colitis
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Skin infection
|
5.6%
1/18 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bruising
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
3/18 • Number of events 3
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
6/18 • Number of events 9
|
|
Investigations
Aspartate aminotransferase increased
|
38.9%
7/18 • Number of events 12
|
|
Investigations
Bilirubin increased
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Creatinine increased
|
22.2%
4/18 • Number of events 5
|
|
Investigations
Leukocyte count decreased
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Lipase increased
|
22.2%
4/18 • Number of events 4
|
|
Investigations
Neutrophil count decreased
|
55.6%
10/18 • Number of events 25
|
|
Investigations
Platelet count decreased
|
94.4%
17/18 • Number of events 34
|
|
Investigations
Weight loss
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
55.6%
10/18 • Number of events 19
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
11.1%
2/18 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
11.1%
2/18 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
22.2%
4/18 • Number of events 5
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
11.1%
2/18 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
11.1%
2/18 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
2/18 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Headache
|
16.7%
3/18 • Number of events 10
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.6%
1/18 • Number of events 5
|
|
Nervous system disorders
Taste alteration
|
22.2%
4/18 • Number of events 9
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.2%
4/18 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hemorrhage
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
2/18 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.6%
1/18 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
11.1%
2/18 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
11.1%
2/18 • Number of events 2
|
|
Vascular disorders
Hypertension
|
27.8%
5/18 • Number of events 16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60