Trial Outcomes & Findings for Green Tea Extract in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia (NCT NCT00262743)
NCT ID: NCT00262743
Last Updated: 2013-05-30
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
PHASE1/PHASE2
73 participants
6 months
2013-05-30
Participant Flow
A total of 73 participants were enrolled at the Mayo Clinic from August 2005 - October 2009.
Thirty-six (36) and 37 patients recruited to the phase I and phase II portions, respectively. Three phase I patients were replaced and one patient was ineligible for evaluation. Per study design, the 36 eligible phase II participants along with the 6 phase I participants treated at the phase II dose level were evaluated (n=42).
Participant milestones
| Measure |
Phase I Polyphenon E
Dose ranging from 400 to 1,800 mg orally twice a day for 6 months
|
Phase II Polyphenon E
2000mg orally twice daily for 6 months
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
42
|
|
Overall Study
COMPLETED
|
27
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
12
|
Reasons for withdrawal
| Measure |
Phase I Polyphenon E
Dose ranging from 400 to 1,800 mg orally twice a day for 6 months
|
Phase II Polyphenon E
2000mg orally twice daily for 6 months
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
9
|
|
Overall Study
Disease progression
|
0
|
3
|
Baseline Characteristics
Green Tea Extract in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Phase I Polyphenon E
n=27 Participants
Dose ranging from 400 to 1,800 mg orally twice daily for 6 months
|
Phase II Polyphenon E
n=42 Participants
2000mg twice daily for 6 months
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
62 years
n=5 Participants
|
60 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
42 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Dose Level of Polyphenon E
400 mg
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Dose Level of Polyphenon E
800 mg
|
6 participants
n=5 Participants
|
0 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Dose Level of Polyphenon E
1000 mg
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Dose Level of Polyphenon E
1200 mg
|
6 participants
n=5 Participants
|
0 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Dose Level of Polyphenon E
1400 mg
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Dose Level of Polyphenon E
1600 mg
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Dose Level of Polyphenon E
1800 mg
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Dose Level of Polyphenon E
2000 mg
|
0 participants
n=5 Participants
|
42 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Fluorescence In Situ Hybridization (FISH) Abnormalities
Normal
|
6 participants
n=5 Participants
|
10 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Fluorescence In Situ Hybridization (FISH) Abnormalities
deletion (13q14.2)
|
17 participants
n=5 Participants
|
27 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Fluorescence In Situ Hybridization (FISH) Abnormalities
Trisomy 12
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Fluorescence In Situ Hybridization (FISH) Abnormalities
deletion (11q23)
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Rai Stage
Stage 0
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Rai Stage
Stage I
|
8 participants
n=5 Participants
|
24 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Rai Stage
Stage II
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
ZAP-70 Status
Positive (>=20%)
|
6 participants
n=5 Participants
|
12 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
ZAP-70 Status
Negative (<20%)
|
21 participants
n=5 Participants
|
30 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
CD38 Status
Positive (>=30%)
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
CD38 Status
Negative (<30%)
|
23 participants
n=5 Participants
|
35 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Immunoglobulin Variable Heavy Chain (IGVH) Mutation Status
Unmutated (<=2%)
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Immunoglobulin Variable Heavy Chain (IGVH) Mutation Status
Mutated (>2%)
|
18 participants
n=5 Participants
|
27 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Immunoglobulin Variable Heavy Chain (IGVH) Mutation Status
Unavailable
|
2 participants
n=5 Participants
|
9 participants
n=7 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Phase II participants who satisfied all eligibility criteria, signed the consent form and started therapy were evaluated for this endpoint.
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 |
Phase II Polyphenon E
n=42 Participants
2000mg twice daily for 6 months
|
|---|---|
|
Number of Participants With a Confirmed Response [Complete Response (CR) and Partial Response (PR)] on 2 Consecutive Evaluations at Least 4 Weeks Apart
|
1 participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Phase II participants who satisfied all eligibility criteria, signed the consent form and started therapy were evaluated for this endpoint.
Bio-R: A reduction in the absolute lymphocyte count (ALC) of more than 20% from the pretreatment level for at least 2 months or a \>= 30% reduction in all palpable lymphadenopathy without meeting the NCIWG criteria for PR was required
Outcome measures
| Measure |
Phase II Polyphenon E
n=42 Participants
2000mg twice daily for 6 months
|
|---|---|
|
Number of Participants With Biological Response (Bio-R) on 2 Consecutive Evaluations at Least 4 Weeks Apart
|
28 participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Phase II participants who satisfied all eligibility criteria, signed the consent form and started therapy were evaluated for this endpoint.
A confirmed complete response is a CR which is reported on 2 consecutive cycles at least 4 weeks apart. CR is defined in Primary Outcome Measure #1.
Outcome measures
| Measure |
Phase II Polyphenon E
n=42 Participants
2000mg twice daily for 6 months
|
|---|---|
|
Number of Participants With a Confirmed Complete Response (CR)
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 months (from registration)Population: Phase II participants who satisfied all eligibility criteria, signed the consent form and started therapy were evaluated for this endpoint.
Percentage of participants who were alive and treatment (for progressive CLL) free at 24 months. The 24 month treatment free survival, with 95% CI, was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Phase II Polyphenon E
n=42 Participants
2000mg twice daily for 6 months
|
|---|---|
|
24 Month Treatment Free Survival Rate
|
79 percentage of participants
Interval 62.0 to 92.0
|
Adverse Events
Phase II Polyphenon E
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase II Polyphenon E
n=42 participants at risk
2000mg orally twice daily for 6 months
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
28.6%
12/42 • Number of events 27
|
|
Eye disorders
Vision blurred
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
28.6%
12/42 • Number of events 21
|
|
Gastrointestinal disorders
Abdominal pain
|
47.6%
20/42 • Number of events 37
|
|
Gastrointestinal disorders
Constipation
|
11.9%
5/42 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhea
|
69.0%
29/42 • Number of events 68
|
|
Gastrointestinal disorders
Dyspepsia
|
28.6%
12/42 • Number of events 24
|
|
Gastrointestinal disorders
Esophageal ulcer
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
35.7%
15/42 • Number of events 32
|
|
Gastrointestinal disorders
Mucositis oral
|
9.5%
4/42 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
64.3%
27/42 • Number of events 71
|
|
Gastrointestinal disorders
Vomiting
|
11.9%
5/42 • Number of events 5
|
|
General disorders
Edema limbs
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Fatigue
|
52.4%
22/42 • Number of events 59
|
|
General disorders
Fever
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Flu-like symptoms
|
23.8%
10/42 • Number of events 12
|
|
Immune system disorders
Hypersensitivity
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Infection
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Skin infection
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
2.4%
1/42 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
52.4%
22/42 • Number of events 57
|
|
Investigations
Alkaline phosphatase increased
|
14.3%
6/42 • Number of events 30
|
|
Investigations
Aspartate aminotransferase increased
|
45.2%
19/42 • Number of events 32
|
|
Investigations
Blood bilirubin increased
|
9.5%
4/42 • Number of events 13
|
|
Investigations
Creatinine increased
|
2.4%
1/42 • Number of events 2
|
|
Investigations
Neutrophil count decreased
|
11.9%
5/42 • Number of events 11
|
|
Investigations
Platelet count decreased
|
35.7%
15/42 • Number of events 34
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
14/42 • Number of events 25
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
16.7%
7/42 • Number of events 18
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
7.1%
3/42 • Number of events 8
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
4.8%
2/42 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
2.4%
1/42 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
1/42 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
2/42 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.4%
1/42 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
2.4%
1/42 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.4%
1/42 • Number of events 5
|
|
Nervous system disorders
Dizziness
|
11.9%
5/42 • Number of events 6
|
|
Nervous system disorders
Extrapyramidal disorder
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Headache
|
31.0%
13/42 • Number of events 21
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.4%
1/42 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
4.8%
2/42 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.8%
2/42 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.4%
1/42 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
7.1%
3/42 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Sweating
|
4.8%
2/42 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place