Celgene 009

Trial overview

A Phase 2, Multi-Center, Randomized, Double-Blind, Parallel-Group Study Of

The Safety And Efficacy Of Different Lenalidomide (Revlimid®) Dose Regimens In Subjects

With Relapsed Or Refractory B-Cell Chronic Lymphocytic Leukemia

Inclusion criteria

Must understand and voluntarily sign an informed consent form

•

Age ≥ 18 years at the time of signing the informed consent form

•

Must be able to adhere to the study visit schedule and other protocol requirements

•

and treatment of CLL (

Must have a documented diagnosis of B-cell CLL [iwCLL guidelines for diagnosisHallek, 2008)] meeting at least one of the following criteria:

−

worsening of, anemia and/or thrombocytopenia

Evidence of progressive marrow failure as manifested by the development of, or

−

symptomatic splenomegaly

Massive (i.e., > 6 cm below the left costal margin) or progressive or

−

lymphadenopathy

Massive nodes (i.e., > 10 cm in longest diameter) or progressive or symptomatic

−

lymphocyte doubling time (LDT) of less than 6 months

Progressive lymphocytosis with an increase of > 50% over a 2 month period, or

−

present:

A minimum of any one of the following disease-related symptoms must be

−

Unintentional weight loss ≥ 10% within the previous 6 months

−

usual activities)

Significant fatigue (i.e., ECOG PS 2; cannot work or unable to perform

−

evidence of infection

Fevers of greater than 100.5° F or 38.0° C for 2 or more weeks without other

−

Night sweats for more than 1 month without evidence of infection

•

treatment of CLL [relapsed / refractory as defined per the iwCLL guidelines for

diagnosis and treatment of CLL (

must have included a purine analog-based regimen

Must be relapsed or refractory to at least 1 but no more than 3 prior regimen(s) forHallek, 2008)]. At least one of the prior treatments

−

complete remission (CR) or partial remission (PR), but after a period of

months, demonstrates evidence of disease progression

Relapsed is defined as a subject who has previously achieved the criteria of a≥6

−

response, or progressive disease] or disease progression within 6 months to the

last antileukemic therapy

Refractory is defined as treatment failure [e.g. Stable disease (SD), non

•

score of

Must have an Eastern Cooperative Oncology Group (ECOG) performance status≤2.

•

Females of childbearing potential (FCBP) must:

−

drug. She must agree to ongoing pregnancy testing during study therapy and

after discontinuation of study drug as specified in Appendix

even if the subject practices complete and continued sexual abstinence.

Have a negative medically supervised pregnancy test prior to starting study21.9. This applies

−

must be reviewed on a monthly basis) or agree to use, and be able to comply

with, effective contraception without interruption, prior to starting study drug,

during study drug therapy, and after discontinuation of study drug as specified

in Appendix

Either commit to continued abstinence from heterosexual intercourse (which21.9.

•

Male subjects must:

−

had a vasectomy, during study drug therapy and after discontinuation of study

drug as specified in Appendix

Agree to use a condom during sexual contact with a FCBP, even if they have21.9.

−

discontinuation of study drug as specified in Appendix

Agree to not donate semen or sperm during study drug therapy and after21.9.

•

Have an understanding that the study drug could have a potential teratogenic

risk

All subjects must:

−

discontinuation of study drug as specified in Appendix

Agree to abstain from donating blood during study drug therapy and after21.9.

−

Agree not to share study drug with another person

−

specified in Appendix

Be counseled about pregnancy precautions and risks of fetal exposure as21.9.

Exclusion criteria

•

Any serious medical condition, laboratory abnormality, or psychiatric illness that

•

Active infections requiring systemic antibiotics

•

treatment

Systemic treatment for B-cell CLL within 28 days of initiation of lenalidomide

•

Alemtuzumab therapy within 120 days of initiating lenalidomide treatment

•

More than 3 prior regimens for treatment of CLL

•

Prior therapy with lenalidomide

•

History of grade 4 rash due to prior thalidomide treatment

•

Planned autologous or allogeneic bone marrow transplantation

•

Pregnant or lactating females

•

or imaging. Subjects who have signs or symptoms suggestive of leukemic

meningitis or a history of leukemic meningitis must have a lumbar puncture

procedure performed within two weeks prior to initiating study drug

Central nervous system (CNS) involvement as documented by spinal fluid cytology

•

the disease for

Prior history of malignancies, other than CLL, unless the subject has been free of≥2 years. Exceptions include the following:

−

Basal cell carcinoma of the skin

−

Squamous cell carcinoma of the skin

−

Carcinoma in situ of the cervix

−

Carcinoma in situ of the breast

−

Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)

•

History of renal failure requiring dialysis

•

Hepatitis C Virus (HCV) infection

Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and/or

•

be enrolled upon correction of electrolyte abnormalities)

Evidence of TLS per the Cairo-Bishop definition of laboratory TLS (subjects may

•

Any of the following laboratory abnormalities:

−

(creatinine clearance may also be obtained by the 24-hour collection method at

the investigator’s discretion)

Calculated (method of Cockroft-Gault) creatinine clearance of <60 mL/min

−

Absolute neutrophil count (ANC) < 1,000/μL (1.0 X 109/L)

−

Platelet count < 50,000/μL (50 X 109/L)

−

transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate

transaminase (SGPT) > 3.0 x upper limit of normal (ULN)

Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic

−

Serum total bilirubin > 1.5 x ULN

•

Uncontrolled hyperthyroidism or hypothyroidism

•

Venous thromboembolism within 12 months

•

≥ Grade-2 neuropathy

•

Uncontrolled autoimmune hemolytic anemia or thrombocytopenia

•

leukemia]

Disease transformation [i.e. Richter’s Syndrome (lymphomas) or prolymphocytic

•

28 days prior to initiating lenalidomide therapy

Participation in any clinical study or having taken any investigational therapy within

•

Known presence of alcohol and/or drug abuse

would prevent the subject from signing the informed consent form

Contact details

Research Nurse

Alex Stichler

Tel 0113 2067420

Email alex.stichler@leedsth.nhs.uk

Research Nurse

David Buchanan

Tel 0113 2067436

Email david.buchanan@leedth.nhs.uk

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Tags

revlimid