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Green Tea Extract in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00262743
First received: December 6, 2005
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
Results First Received: December 7, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Leukemia
Intervention: Biological: Polyphenon E

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 73 participants were enrolled at the Mayo Clinic from August 2005 - October 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Thirty-six (36) and 37 patients recruited to the phase I and phase II portions, respectively. 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).

Reporting Groups
  Description
Polyphenon E 2000mg twice daily for 6 months

Participant Flow:   Overall Study
    Polyphenon E  
STARTED     42  
COMPLETED     31  
NOT COMPLETED     11  



  Baseline Characteristics
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Reporting Groups
  Description
Polyphenon E 2000mg twice daily for 6 months

Baseline Measures
    Polyphenon E  
Number of Participants  
[units: participants]
 		  42  
Age  
[units: years]
Median ( Full Range ) 		  60  
  ( 41 to 78 )  
Gender  
[units: participants]
 		 
Female     12  
Male     30  
Region of Enrollment  
[units: participants]
 		 
United States     42  
Fluorescence In Situ Hybridization (FISH) Abnormalities [1]
[units: participants]
 		 
Normal     10  
deletion (13q14.2)     27  
Trisomy 12     4  
deletion (11q23)     1  
Rai Stage [2]
[units: participants]
 		 
Stage 0     14  
Stage I     23  
Stage II     5  
ZAP-70 Status [3]
[units: participants]
 		 
Positive (>=20%)     11  
Negative (<20%)     24  
Unavailable     7  
CD38 Status [4]
[units: participants]
 		 
Positive (>=30%)     6  
Negative (<30%)     29  
Unavailable     7  
Immunoglobulin Variable Heavy Chain (IGVH) Mutation Status [5]
[units: participants]
 		 
Unmutated (<=2%)     6  
Mutated (>2%)     27  
Unavailable     9  
[1] This test determines the presence of abnormalities in specific chromosomes of CLL cells, which are associated with more or less aggressive forms of cancer. Patients with abnormalities of chromosome 11 (deletion 11q23) and 17 (deletion 17p13) experience rapid progression of their CLL.
[2]

Rai staging is a way to categorize the disease progression of chronic lymphocytic leukemia (CLL); higher stages reflect increasing severity.

Rai Stage 0: Lymphocytosis only, Rai Stage I: Lymphocytosis and lymphadenopathy, Rai Stage II: Lymphocytosis and hepatomegaly +/- splenomegaly
[3] This test is used to predict the rate of progression from diagnosis to need for treatment in CLL. Participants with positive ZAP-70 (>=20%) tend to experience a more aggressive course of CLL.
[4] This test is used to predict the rate of progression from diagnosis to need for treatment in CLL. Participants with positive CD38 (>=30%) tend to experience a more aggressive course of CLL.
[5] IGVH testing helps predict which patients will experience a more aggressive (if the gene is unmutated, <=2%) or less aggressive (if the gene is mutated, >2%) course of CLL. This technically complex test is only available at select medical institutions.



  Outcome Measures
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1.  Primary:   Number of Participants With a Confirmed Response [Complete Response (CR) and Partial Response (PR)] on 2 Consecutive Evaluations at Least 4 Weeks Apart   [ Time Frame: 6 months ]
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2.  Primary:   Number of Participants With Biological Response (Bio-R) on 2 Consecutive Evaluations at Least 4 Weeks Apart   [ Time Frame: 6 months ]
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3.  Secondary:   Number of Participants With a Confirmed Complete Response (CR)   [ Time Frame: 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Tait Shanafelt
Organization: Mayo Clinic
e-mail: shanafelt.tait@mayo.edu


Publications of Results:


Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00262743     History of Changes
Obsolete Identifiers: NCT00166335
Other Study ID Numbers: CDR0000454773, P30CA015083, MC0419, 1155-05, NCI-2009-01227
Study First Received: December 6, 2005
Results First Received: December 7, 2011
Last Updated: January 16, 2013
Health Authority: United States: Food and Drug Administration