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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00751296
• Date of registration: 10/09/2008
• Primary sponsor: University Health Network, Toronto
• Public title: Study of Lenalidomide in Previously Untreated, Symptomatic Chronic Lymphocytic Leukemia (CLL) Rev-CLL
• Scientific title: A Phase 2 Study of Lenalidomide in Previously Untreated, Symptomatic Chronic Lymphocytic Leukemia (CLL)
• Date of first enrolment: August 2006
• Target sample size: 27
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00751296
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Canada

Key inclusion & exclusion criteria

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
surgery.

- 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
discretion

- 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
available)

- 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
potential.

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Lymphocytic Leukaemia

Intervention(s)

Drug: Lenalidomide

Primary Outcome(s)

To assess the efficacy (response rate) of oral lenalidomide in the treatment of patients with symptomatic, previously untreated, chronic lymphocytic leukemia (CLL) [Time Frame: Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).]

Secondary Outcome(s)

To assess the toxicity of lenalidomide in patients with CLL [Time Frame: Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).]

Secondary ID(s)

Rev-06-0099

RV-CLL-PI-0099

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Celgene Corporation