Phase 2
N=69
Green Tea Extract in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia
Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00262743 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Polyphenon E (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Confirmed Response [Complete Response (CR) and Partial Response (PR)] on 2 Consecutive Evaluations at Least 4 Weeks Apart |
1 | — |
| PRIMARY Number of Participants With Biological Response (Bio-R) on 2 Consecutive Evaluations at Least 4 Weeks Apart |
28 | — |
| SECONDARY Number of Participants With a Confirmed Complete Response (CR) |
— | — |
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).
Eligibility Criteria
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 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 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
Data sourced from ClinicalTrials.gov (NCT00262743). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.