Lenalidomide in Patients With Chronic Lymphocytic Leukemia Older Than 65 Years of Age - Full Text View

Purpose

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.

Condition	Intervention	Phase
Chronic Lymphocytic Leukemia Leukemia	Drug: lenalidomide	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of Lenalidomide in Patients With Chronic Lymphocytic Leukemia Older Than 65 Years of Age

Resource links provided by NLM:

MedlinePlus related topics: Cancer Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Lenalidomide

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

To assess the efficacy of continuous lenalidomide therapy in patients ≥ 65. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the toxicity profile of lenalidomide. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	November 2009
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: pts getting lenalidomide Patients with intermediate or high-risk chronic lymphocytic leukemia (≥ 65 years old) will receive lenalidomide until disease progression at the 20mg dose level (recognizing that progression at this dose requires non-protocol alternate therapy) or unacceptable toxicity.	Drug: lenalidomide Lenalidomide will be administered orally at a starting dose of 2.5mg once daily, days 1-28. Patients will be evaluated prior to treatment and at 4 weeks, 8 weeks, 12 weeks, 16 weeks and at a minimum of 4 weeks thereafter until removal from study. Patients with stable disease or better will continue at their current dose unless they experience toxicity requiring dose reduction. For those patients who have progressive disease on their current dose and have no dose-limiting toxicity, their dose will be increased from 2.5mg, to 5mg, to 10mg, to 15mg, to 20mg one dose level at a time not more frequently than once every 4 weeks. The maximum dose will be 20mg. Other Names: Responding patients and those with stable disease will continue lenalidomide at their current dose level and will continue to be evaluated at the above time points. Following 16 weeks, evaluation will occur at a minimum of every 4 weeks until removal from the study. Patients who have stable disease or are responding following the first year of treatment will be required to have monthly blood work but can be seen at no less than 3 month intervals.

Arms

Assigned Interventions

Experimental: pts getting lenalidomide

Patients with intermediate or high-risk chronic lymphocytic leukemia (≥ 65 years old) will receive lenalidomide until disease progression at the 20mg dose level (recognizing that progression at this dose requires non-protocol alternate therapy) or unacceptable toxicity.

Drug: lenalidomide

Lenalidomide will be administered orally at a starting dose of 2.5mg once daily, days 1-28. Patients will be evaluated prior to treatment and at 4 weeks, 8 weeks, 12 weeks, 16 weeks and at a minimum of 4 weeks thereafter until removal from study. Patients with stable disease or better will continue at their current dose unless they experience toxicity requiring dose reduction. For those patients who have progressive disease on their current dose and have no dose-limiting toxicity, their dose will be increased from 2.5mg, to 5mg, to 10mg, to 15mg, to 20mg one dose level at a time not more frequently than once every 4 weeks. The maximum dose will be 20mg.

Other Names:

Responding patients and those with stable disease will continue lenalidomide
at their current dose level and will continue to be evaluated at the above
time points. Following 16 weeks, evaluation will occur at a minimum of every 4 weeks until
removal from the study. Patients who have stable disease or are responding following the first
year of treatment will be required to have monthly blood work but can be seen at no less than 3
month intervals.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01011894

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Celgene Corporation

Investigators

Principal Investigator:

Renier Brentjens, MD, PhD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT01011894 History of Changes
Other Study ID Numbers:	09-045
Study First Received:	November 9, 2009
Last Updated:	February 27, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Lenalidomide
CLL
09-045

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Thalidomide
Antineoplastic Agents

Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013