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A Phase II Study of Atorvastatin in Patients With Low Grade or Refractory Non-Hodgkin's Lymphoma

Phase 2
18 Years
Open (Enrolling)
Leukemia, Lymphoma, Non-Hodgkin

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Trial Information

A Phase II Study of Atorvastatin in Patients With Low Grade or Refractory Non-Hodgkin's Lymphoma

Inclusion Criteria:

- >18 years old

- Disease criteria: Confirmed by Stanford Pathology to be one of the following
Non-Hodgkin's Lymphoma subtypes:

- Chronic lymphocytic leukemia /small lymphocytic lymphoma (CLL/SLL)

- Extranodal marginal zone B-cell lymphoma

- Nodal marginal zone B-cell lymphoma

- Splenic marginal zone B-cell lymphoma

- Treatment criteria

- Untreated: watchful waiting currently appropriate (includes CLL stage 0) o OR

- Prior treatment: watchful waiting currently appropriate o OR

- Refractory disease

- Staging within 4 weeks prior to enrollment (SLL, marginal zone lymphoma)

- CT chest (date)

- CT abdomen (date)

- CT pelvis (date)


- Staging within 4 weeks prior to enrollment (CLL: CT not required)

- Total White Cell Count (WBC) (Value) (date)

- Absolute Lymphoma Cell Count (ALC) (Value) (date)

- Measurable disease

1. (Site)

2. (Size) OR

- CLL (only): Elevated Absolute Lymphoma Cell Count

- Disease amenable to biopsy (must check at least one): Li circulating tumor cells

- Li positive bone marrow

- Li palpable involved site (such as lymph node) measuring >1.5 cm

ECOG performance status <2 (Karnofsky >60)

o Status score:

- Life expectancy of greater than 3 months

- Patients must have adequate organ and marrow function (EACH must checked "yes")

1. Li absolute neutrophil count >1 ,000/uL

2. Li platelets >30,000/uL

3. Li total bilirubin within normal institutional limits

4. Li AST(SGOT) <2.5 X institutional upper limit of normal

5. Li ALT(SGPT) <2.5 X institutional upper limit of normal

6. Li creatinine within normal institutional limits OR creatinine clearance >60
mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and
for the duration of study participation. Women of child-bearing potential must have
negative BetaHCG at enrollment

Exclusion Criteria:

- Patient has had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas
or mitomycin C) prior to entering the study

- Patient has not recovered from adverse events due to agents administered more than
four weeks earlier

- Patient with stable low grade lymphoma has had rituximab within 3 months Patient with
relapsed or refractory disease has had rituximab within 1 month

- Patient has not recovered from adverse events due to surgery performed 4 weeks

- Patient is receiving any other investigational agent. Known brain metastases

- Patient has taken any statin within the past 6 months prior to enrollment in the

- Patient currently abuses alcohol

- Patient currently takes cyclosporin or gemfibrozil Patient has a prior history of

- Patient as uncontrolled intercurrent illness including, but not limited to ongoing or
active infection, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia, or psychiatric illness/social situations that would limit
compliance with study requirements.

- Patient is pregnant. Note: Patients are not excluded if they are breastfeeding at the
time of enrollment, but breastfeeding should be discontinued if the mother is treated
with atorvastatin.

- HIV-positive patients receiving combination anti-retroviral therapy

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine changes in levels of tumor bioactivity upon treatment with atorvastatin.

Outcome Time Frame:

Endpoint is assessed every 3 months, up to 1 year after starting atorvastatin treatment. Fine needle aspirate and blood samples are batched and analyzed within 1 year of obtaining each sample endpoint.

Safety Issue:


Principal Investigator

Dean Felsher

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Institutional Review Board

Study ID:




Start Date:

April 2005

Completion Date:

December 2015

Related Keywords:

  • Leukemia
  • Lymphoma, Non-Hodgkin
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin



Stanford University School of Medicine Stanford, California  94305-5317