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

Phase 2
18 Years
Open (Enrolling)
Chronic Lymphocytic Leukaemia

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Trial Information

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

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

Inclusion Criteria:

- Understand and voluntarily sign an informed consent form.

- Age ³18 years at the time of signing the informed consent form.

- Able to adhere to the study visit schedule and other protocol requirements.

- A confirmed diagnosis of B-cell CLL by NCI Working Group criteria

- No prior systemic therapy for CLL. Steroid therapy alone for autoimmune cytopenias
(anemia or thrombocytopenia) is NOT considered a prior systemic therapy.

- Radiation: Patients may have received prior radiation therapy restricted to < 25% of
functioning bone marrow. Patients must be > 4 weeks since last treatment with
radiation therapy.

- Surgery: previous surgery is permissible. Patient must be > 4 weeks since any major

- Patients must have symptomatic disease requiring therapy. One or more of the
following must be present to be eligible:

- Symptomatic lymphadenopathy

- Hepatomegaly and/or splenomegaly

- Anemia (Hb <110 g/L)

- Thrombocytopenia (platelets <100)

- Fatigue, weight loss, night sweats, fever (without infection) or other
constitutional symptoms felt to require treatment as per treating physician

- Persistent rise in lymphocyte count with doubling time of < 12 months

- ECOG performance status of
- Laboratory Requirements: (must be done within 7 days prior to first study drug dose)

Hematology: Absolute granulocytes (AGC) > 1.0 x 109/L Platelets > 50 x 109/L Chemistry:
Serum creatinine < 1.5 x UNL Bilirubin < 1.5 x UNL AST (or ALT if AST < 2.5 x UNL not

- Women of childbearing potential (WCBP)† must have a negative serum or urine pregnancy
test with a sensitivity of at least 50 mIU/mL 10 - 14 days prior to therapy and
repeated within 24 hours of starting study drug and must either commit to continued
abstinence from heterosexual sexual intercourse or begin TWO acceptable methods of
birth control, one highly effective methods and one additional effective method AT
THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. In addition,
sexually active WCBP must agree to ongoing pregnancy testing.. Men must agree not to
father a child and agrees to use a condom if his partner is of child bearing

- Disease free of prior malignancies for ³ 5 years with exception of currently treated
basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix
or breast

Exclusion Criteria:

- Patients who fulfill any of the following criteria are not eligible for admission to
the study:

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

- Pregnant or lactating females. (Lactating females must agree not to breast feed while
taking lenalidomide).

- 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.

- Patients previously or currently receiving treatment with other anti-cancer therapy
for CLL

- Lymphoproliferative disease other than CLL (includes patients with prolymphocytic
leukemia, mantle cell lymphoma, and those who have transformed to a more aggressive
lymphoma, or Richter's syndrome).

- 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.

- Concurrent use of other anti-cancer agents or treatments.

- Known positive for HIV or infectious hepatitis, type A, B or C.

Type of Study:


Study Design:

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

Outcome Measure:

To assess the efficacy (response rate) of oral lenalidomide in the treatment of patients with symptomatic, previously untreated, chronic lymphocytic leukemia (CLL)

Outcome Time Frame:

Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2006

Completion Date:

Related Keywords:

  • Chronic Lymphocytic Leukaemia
  • Lenalidomide
  • immunomodulatory drug (IMiD®)
  • Thalidomide analogues
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid