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LeukemiaPhase 1/2NCT00262743

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

A Phase 1/2 study testing Polyphenon E in people with Leukemia, run by Mayo Clinic at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia
What is being tested?
Polyphenon E
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
2 sitesUnited States
Study dates
Aug 2005to Aug 2012
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Mayo Clinic in Arizona

    Scottsdale, Arizona

Other trials in United States

About this study

Official title: A Phase I/II Study of Daily Oral Polyphenon E in Asymptomatic, Rai Stage 0-II Patients With Chronic Lymphocytic Leukemia

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).

Read the detailed description

OBJECTIVES:

Phase I

  • Determine the maximally tolerated dose of green tea extract (Polyphenon E) in patients with previously untreated stage 0-II chronic lymphocytic leukemia.
  • Describe the dose-limiting toxicity of green tea extract (Polyphenon E).

Phase II

  • Evaluate the response rate and response duration of patients with previously untreated, asymptomatic Rai stage 0-II chronic lymphocytic leukemia treated with green tea extract (Polyphenon E) for 6 months at the MTD.
  • Further characterize toxicity.

OUTLINE: This is a phase I, dose-escalation study of green tea extract (Polyphenon E) followed by a phase II study.

  • Phase I: Patients receive oral green tea extract (Polyphenon E) once or twice daily for 4 weeks. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of green tea extract (Polyphenon E) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

  • Phase II: Patients receive green tea extract (Polyphenon E) as in the phase I portion of the study at the MTD.

After completion of study treatment, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 73 patients will be accrued for this study.

Conditions
Leukemia
Being tested
Polyphenon E
Keywords
B-cell chronic lymphocytic leukemia, stage 0 chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia
Medical subject headings
Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Polyphenon EBiological

    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

Study groups in NCT00262743
Study groupRoleWhat they receive
polyphenon EExperimentalDesigned to assess toxicity, treatment response, and pertinent laboratory measurements in patients with previously untreated, asymptomatic, Rai Stage 0-II CLL.
Receives: Biological: Polyphenon E

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months

  2. 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

    Measured: 6 months

Secondary outcomes (1)

  1. Number of Participants With a Confirmed Complete Response (CR)

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2005 (estimated)
  2. Study startAug 2005
  3. Primary completionMay 2010
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00262743
Sponsor's protocol ID
CDR0000454773
Other IDs
P30CA015083, 1155-05, NCI-2009-01227, MC0419
Status last verified
May 2013
First submitted
6 Dec 2005
Last updated
30 May 2013

Publications

  • 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.

    PubMed 19470922

  • 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.

    PubMed 22760587

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Polyphenon E in people with Leukemia, run by Mayo Clinic at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00262743, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2013.

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