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A Phase II Study of Lenalidomide in Patients With Chronic Lymphocytic Leukemia Older Than 65 Years of Age

Phase 2
65 Years
Open (Enrolling)
Chronic Lymphocytic Leukemia, Leukemia

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Trial Information

A Phase II Study of Lenalidomide in Patients With Chronic Lymphocytic Leukemia Older Than 65 Years of Age

Inclusion Criteria:

- Patients with either previously untreated or treated disease must have either
intermediate or high-risk chronic lymphocytic leukemia as defined by the three-stage
Rai system. Patients with Rai intermediate risk disease should meet the criteria for
active disease as outlined by the NCI Working Group guidelines (including weight
loss, fatigue, fevers, evidence of progressive marrow failure, splenomegaly,
progressive lymphadenopathy, or progressive lymphocytosis with a rapid doubling

- MSKCC pathologist must confirm patient's disease.

- To be considered CLL the patient must have an absolute lymphocytosis in the blood of
at least 5,000 lymphocytes per microliter, or bone marrow lymphocytosis greater than
or equal to 30% of all nucleated cells

- Immunophenotypic (or immunohistochemical) analysis of the malignant lymphocytes
should demonstrate that the cells are B-cells. Typically these cells should also
express CD5 and CD23. It is recognized that an occasional patient with CLL may have a
slightly aberrant immunophenotype. All such cases need to be reviewed with the
principal investigator prior to being registered for the study. Patients with small
lymphocytic lymphoma (CLL type) will be eligible for this study.

- Age ≥ 65 years of age.

- Karnofsky performance status ≥ 50%

- ANC ≥ 0.8 and platelet count ≥ 30,000

- Total creatinine ≤ 2.0mg/dl or creatinine clearance ≥ 30ml/min.

- Total bilirubin ≤ 3.0 mg/dL (not attributable to autoimmune hemolytic anemia).

- Signed informed consent, which indicates the investigational nature of this study, is

- No patient may be entered onto the study without consultation with the principal
investigator or his designee.

- Men must agree to use a latex condom during sexual contact with a FCBP even if they
have had a successful vasectomy. All patients must be counseled at a minimum of every
28 days about pregnancy precautions and risks of fetal exposure.

Exclusion Criteria:

- Patients with significant active infections.

- Men should use effective contraception.

- Patients known positive for HIV or with active infection from hepatitis, A, B, or C.

- Concomitant chemotherapy or radiotherapy while on protocol.

- Evidence of laboratory TLS by Cairo-Bishop Definition of Tumor Lysis Syndrome.

- History of thromboembolic disease within the past 6 months, regardless of

- Myocardial infarction within 6 months prior to enrollment, or New York Hospital
Association (NYHA) Class III or IV heart failure , uncontrolled angina, severe
uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia
or active conduction system abnormalities.

- Known hypersensitivity to thalidomide.

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

- Any prior use of lenalidomide.

Type of Study:


Study Design:

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

Outcome Measure:

To assess the efficacy of continuous lenalidomide therapy in patients ≥ 65.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Renier Brentjens, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

November 2009

Completion Date:

November 2013

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Leukemia
  • Lenalidomide
  • CLL
  • 09-045
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



Memorial Sloan-Kettering Cancer Center New York, New York  10021