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Chronic Lymphocytic Leukemia

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Lenalidomide

Thalidomide

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Angiogenesis Inhibitors

Growth Inhibitors

Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.

Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle.Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).

Christine I Chen, MD

This study will assess the

* efficacy (response rate) of oral lenalidomide in the treatment of patients with symptomatic, previously untreated, chronic lymphocytic leukemia (CLL),
* toxicity of lenalidomide in patients with CLL as well as time to progression, stable disease duration and, if responses are observed, response duration.

This is a phase II, nonrandomized, single institution study in symptomatic, previously untreated CLL patients. Subjects will receive the study drug, lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Although a maximal dose of 10 mg daily (days 1-21) will be targeted, if a patient is felt by the investigator to be benefiting from doses less than the target dose (i.e. 2.5 mg or 5 mg daily), the investigator may at his discretion choose to hold the patient at that dose without further escalation. For those patients who have progressive disease after cycle 3, further dose escalations as assessed by response and toxicity at the end of each escalated dose cycle to a maximum of 25 mg (days 1-21) will be allowed. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).

Study of Lenalidomide in Previously Untreated, Symptomatic Chronic Lymphocytic Leukemia (CLL)

A Phase 2 Study of Lenalidomide in Previously Untreated, Symptomatic Chronic Lymphocytic Leukemia (CLL)

The primary endpoint was objective response to lenalidomide (Complete response +Partial response) evaluated as per the revised 1996 National Cancer Institute Working Group Guidelines.

Complete response: absence of lymphadenopathy and organomegaly by physical exam and radiology, absence of constitutional symptoms, normal CBC. Bone marrow to be done 2 months after the above criteria are met, must be normocellular, with \<30% lymphocytes.

Partial Response: ≥ 50% decrease in the peripheral blood lymphocytes from pre-treatment value, ≥ 50% reduction in lymphadenopathy and organomegaly by physical exam or on CT scan. one or more of the following: neutrophils ≥ 1.5 x109/L, platelets \> 100 x109/L or 50% improvement over baseline, hemoglobin \> 110 g/L or 50% improvement over baseline (without transfusion).

Assess the time to disease progression and overall survival. (Progressive disease is defined as at least one of the following: more than or equal to 50% increase in the sum of the products of the greatest diameters of at least 2 lymph nodes on 2 consecutive determinations 2 weeks apart (at least one node must be ≥ 2 cm) or new palpable lymph nodes, more than or equal to 50% increase in the size of the liver and/or spleen as determined by measurement below the costal margin or appearance of palpable hepatomegaly or splenomegaly not previously present, more than or equal to 50% increase in the absolute number of circulating lymphocytes to at least 5.0 x109/L, OR transformation to a more aggressive histology (e.g. Richter's syndrome or prolymphocytic leukemia with \>55% prolymphocytes)).

Celgene

University Health Network, Toronto

CTCAE Version 3.0 was used for adverse event grading and categorizing

Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.

Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).

Dose escalation beyond 10 mg daily to a maximum of 25 mgs daily was permitted for nonresponders.

Lenalidiomide

Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.

Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).

Age, Categorical

Age, Continuous

Sex: Female, Male

Canada

Region of Enrollment

Original study protocol used a starting lenalidomide dose of 10mg OD for 21days of a 28-day cycle, escalating weekly by 5mg to a target of 25mg daily. Toxicities reported with the first two enrolled patients lead to the current protocol amendment.

Dr. Christine Chen

Complete response

Partial response

Stable Disease

Severe toxicities were seen in the first two patients enrolled on the initial protocol. The study was halted and the protocol amended to use a starting dose of lenalidomide 2.5 mg with monthly escalations to a target dose of 10 mg, extended tumor lysis prophylaxis and monitoring. 25 response evaluable patients were enrolled on the amended protocol.

To Assess the Efficacy (Response Rate) of Oral Lenalidomide in the Treatment of Patients With Symptomatic, Previously Untreated, Chronic Lymphocytic Leukemia (CLL)

Overall survival

Progression free survival

Percentage of Participants With Progression-free Survival (PFS) and Overall Survival (OS).

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Lenalidomide in Previously Untreated, Symptomatic Chronic Lymphocytic Leukemia (CLL)	NCT00751296	Chronic Lymphoc...	Lenalidomide	18 Years -	University Health Network, Toronto
Study of Lenalidomide in Previously Untreated, Symptomatic Chronic Lymphocytic Leukemia (CLL)	NCT00751296	Chronic Lymphoc...	Lenalidomide	18 Years -	University Health Network, Toronto

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