Lenalidomide in Patients With Chronic Lymphocytic Leukemia Older Than 65 Years of Age
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Leukemia |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2009 |
| End Date: | February 2016 |
A Phase II Study of Lenalidomide in Patients With Chronic Lymphocytic Leukemia Older Than 65 Years of Age
The purpose of this study is to:
Determine the likelihood that lenalidomide will adequately control the disease for at least
one year.
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 is approved by the Food and
Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome
(MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have
received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently
being tested in a variety of cancer conditions.
In this case it is considered experimental. The lenalidomide being administered in this
study is not a commercially marketed product. Although it is expected to be very similar in
safety and activity to the commercially marketed drug, it is possible that some differences
may exist. Because this is not a commercially marketed drug, lenalidomide can only be
administered to patients enrolled in this clinical trial and may only be administered under
the direction of physicians who are investigators in this clinical trial.
Determine the likelihood that lenalidomide will adequately control the disease for at least
one year.
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 is approved by the Food and
Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome
(MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have
received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently
being tested in a variety of cancer conditions.
In this case it is considered experimental. The lenalidomide being administered in this
study is not a commercially marketed product. Although it is expected to be very similar in
safety and activity to the commercially marketed drug, it is possible that some differences
may exist. Because this is not a commercially marketed drug, lenalidomide can only be
administered to patients enrolled in this clinical trial and may only be administered under
the direction of physicians who are investigators in this clinical trial.
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
time)(49).
- 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
required.
- 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
anti-coagulation.
- 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.
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