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A Pilot Study of Lenalidomide as a Chemopreventive Agent for Patients With High-Risk, Early Stage B-Chronic Lymphocytic Leukemia (CLL)

18 Years
Open (Enrolling)
Chronic Lymphocytic Leukemia

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Trial Information

A Pilot Study of Lenalidomide as a Chemopreventive Agent for Patients With High-Risk, Early Stage B-Chronic Lymphocytic Leukemia (CLL)

The purpose of this study is to determine if lenalidomide is safe and effective in the
treatment of patients with high-risk early stage B-Cell CLL who are asymptomatic.

Lenalidomide is a drug that alters the immune system and it may also interfere with the
development of tiny blood vessels that help support tumor growth. Therefore, in theory, it
may reduce or prevent the growth of cancer cells.

Lenalidomide can be an important chemopreventive agent for the treatment of early stage CLL
with defined markers for poor prognosis.

Inclusion Criteria:

- Must have a definitive diagnosis of B-CLL

- Must have early stage B-CLL Rai stage 0, 1, or 2

- Must not have received any prior treatment for management of B-CLL

- Must be assessed to have high risk B-CLL as defined by either one of the following

- High-risk cytogenetics (either 17p deletion or 11 q deletion)

- Unmutated immunoglobulin heavy chain gene rearrangement

- Must understand and voluntarily sign an informed consent form

- Must be ≥ to 18 years of age

- Able to adhere to the study visit schedule or other protocol requirements

- Must have measurable disease with an absolute lymphocytic counts of > 5,000/µL or
measurable lymphadenopathy or organomegaly

- ECOG ≤ 2 at study entry

- Females must have negative pregnancy test

- Able to take aspirin (81 or 325mg) or warfarin sodium daily as prophylactic

- Laboratory test results within these ranges:

- Absolute neutrophil count ≥ 1.0 x 10 9/L

- Platelet count ≥ 30 x 10 9/L

- Serum creatinine < 1.5 x ULN.

- Total bilirubin < 1.5 mg/dL

- AST (SGOT) and ALT (SGPT) ≤ 2 x ULN or ≤ 5 x ULN if hepatic metastases are

Exclusion Criteria:

- Any serious medical condition, laboratory abnormality or psychiatric illness that
would prevent the subject from signing the informed consent

- Pregnant or lactating females

- Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study.

- Use of any other experimental drug or therapy within 28 days of baseline

- Known hypersensitivity to thalidomide or lenalidomide

- Prior history of development of erythema nodosum if characterized by a desquamating
rash while taking thalidomide or similar drugs.

- Patients who have been treated with any prior therapy for B-CLL

- Patients with history of any other cancer

- Patients with history of cardiac arrest within the past 6 months

- Any prior use of lenalidomide

- Concurrent use of other anti-cancer agents or treatments

- History of hepatitis B or C

- Known HIV positive status

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine time to progression in patients with high risk CLL

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Myron Czuczman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Institutional Review Board

Study ID:

RPCI I 136908



Start Date:

January 2010

Completion Date:

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Lenalidomide
  • Chronic Lymphocytic Leukemia
  • B-cell
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



Roswell Park Cancer InstituteBuffalo, New York  14263