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

NCT00262743 | Completed Phase 1 Results

• 5 other identifiers: CDR0000454773P30CA0150831155-05NCI-2009-01227MC0419
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Green tea extract contains ingredients that may slow the growth of certain cancers. PURPOSE: This phase I/II trial is studying the side effects and best dose of green tea extract and to see how well it works in treating patients with stage 0, stage I, or stage II chronic lymphocytic leukemia (CLL).

Conditions

Leukemia

Keywords

B-cell chronic lymphocytic leukemia; stage 0 chronic lymphocytic leukemia; stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia

Outcome Measures

Primary Outcomes (2)

• Number of Participants With a Confirmed Response [Complete Response (CR) and Partial Response (PR)] on 2 Consecutive Evaluations at Least 4 Weeks Apart

  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

  6 months

• Number of Participants With Biological Response (Bio-R) on 2 Consecutive Evaluations at Least 4 Weeks Apart

  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

  6 months

Secondary Outcomes (1)

• Number of Participants With a Confirmed Complete Response (CR)

  6 months

Other Outcomes (1)

• 24 Month Treatment Free Survival Rate

  24 months (from registration)

Study Arms (1)

polyphenon E

EXPERIMENTAL

Designed to assess toxicity, treatment response, and pertinent laboratory measurements in patients with previously untreated, asymptomatic, Rai Stage 0-II CLL.

Biological: Polyphenon E

Interventions

Polyphenon E BIOLOGICAL

Phase I Dose Escalation:. 400 mg orally twice a day to 2000 mg orally twice a day Phase II: 2000 mg orally twice a day

polyphenon E

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Confirmed diagnosis of chronic lymphocytic leukemia (CLL) * Stage 0, I, or II disease * Previously untreated disease * Splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL * Absolute lymphocyte count \> 10,000/mm\^3 * Lymphocytosis must consist of small to moderate size lymphocytes, with ≤ 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically * Phenotypically characterized B-CLL defined by all of the following criteria: * A population of leukemic cells that co-expresses the B-cell antigen CD23 as well as CD5 in the absence of other T-cell markers (CD3, CD2, etc.) * Dim surface immunoglobulin expression * Exclusively κ or λ light chains * Mantle cell lymphoma must be excluded by demonstrating the absence of the t(11:14) by FISH testing * Patients who require chemotherapy for treatment of CLL, based on any of the following criteria, are excluded: * CLL-related symptoms requiring treatment, including any of the following: * Unintentional weight loss ≥ 10% body weight within the previous 6 months * Extreme fatigue * Fevers \> 100.5°F for 2 weeks without evidence of infection * Night sweats without evidence of infection * Evidence of progressive marrow failure due to CLL involvement of bone marrow as manifested by the development of worsening anemia (hemoglobin \< 11 g/dl) and/or thrombocytopenia (platelet count \< 100,000/mm\^3) * Thrombocytopenia due to immune phenomena (ITP) is permitted as long as platelet count is ≥ 100,000/mm\^3and the patient is not on active pharmacologic therapy * Massive (i.e. \> 6 cm below left costal margin) or progressive splenomegaly * Massive nodes or clusters (i.e., \> 10 cm in longest diameter) or progressive adenopathy * Progressive lymphocytosis with an increase of \> 50% over 2 month period, or an anticipated lymphocyte doubling time of \< 6 months PATIENT CHARACTERISTICS: * Platelet count ≥ 100,000/µL * ANC ≥ 1500/µL * Hemoglobin ≥ 11 g/dL * Total or direct bilirubin ≤ 1.5 x upper limit of normal (ULN) * AST (SGOT) and ALT (SGPT) ≤ 2 x ULN * Creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 40 mL/min * May have a history of autoimmune hemolytic anemia (AIHA) and positive Coombs test provided there has not been active hemolysis requiring transfusion or steroid treatment ≤ 10 weeks prior to registration * ECOG performance status 0, 1, or 2 * Life expectancy of ≥ 6 months * No uncontrolled infection * No myocardial infarction within the past 6 weeks * No New York Heart Association class III or IV congestive heart failure * Not pregnant or nursing * Negative pregnancy test * Must employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], or abstinence, etc.) prior to study entry and for the duration of study participation * No other severe medical or psychiatric illness * No active hemolysis requiring transfusion or other pharmacologic therapy PRIOR CONCURRENT THERAPY: * At least 8 weeks since prior and no other concurrent over the counter green tea or green tea extract * No prior daily use of over the counter green tea products for medicinal purposes for \> 4 weeks (phase II only) * No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation) * No concurrent combination anti-retroviral therapy for HIV positive patients * No concurrent oral steroid preparations

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• Shanafelt TD, Call TG, Zent CS, LaPlant B, Bowen DA, Roos M, Secreto CR, Ghosh AK, Kabat BF, Lee MJ, Yang CS, Jelinek DF, Erlichman C, Kay NE. Phase I trial of daily oral Polyphenon E in patients with asymptomatic Rai stage 0 to II chronic lymphocytic leukemia. J Clin Oncol. 2009 Aug 10;27(23):3808-14. doi: 10.1200/JCO.2008.21.1284. Epub 2009 May 26.

  PMID: 19470922 RESULT

• Shanafelt TD, Call TG, Zent CS, Leis JF, LaPlant B, Bowen DA, Roos M, Laumann K, Ghosh AK, Lesnick C, Lee MJ, Yang CS, Jelinek DF, Erlichman C, Kay NE. Phase 2 trial of daily, oral Polyphenon E in patients with asymptomatic, Rai stage 0 to II chronic lymphocytic leukemia. Cancer. 2013 Jan 15;119(2):363-70. doi: 10.1002/cncr.27719. Epub 2012 Jul 3.

  PMID: 22760587 RESULT

MeSH Terms

Conditions

Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

polyphenon E

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Tait Shanafelt
• Organization: Mayo Clinic

shanafelt.tait@mayo.edu

Study Officials

• Tait D. Shanafelt, MD

  Mayo Clinic

  STUDY CHAIR

• Jose F Leis, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2005
• First Posted: December 7, 2005
• Study Start: August 1, 2005
• Primary Completion: May 1, 2010
• Study Completion: August 1, 2012
• Last Updated: May 30, 2013
• Results First Posted: March 13, 2012

Record last verified: 2013-05

Locations

US (2)