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A Dose Escalation Study of Ibrutinib With Lenalidomide for Relapsed and Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

This phase I trial studies the side effects and best dose of lenalidomide when given together with ibrutinib in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that has returned after a period of improvement or does not respond to treatment. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving lenalidomide together with ibrutinib may work better in treating chronic lymphocytic leukemia or small lymphocytic lymphoma.

Stanford is now accepting new patients for this trial. Please contact Asma Khan at 650-724-6008 for more information.



  • drug : ibrutinib
  • drug : lenalidomide
  • other : pharmacological study
  • other : laboratory biomarker analysis

Phase: Phase 1


Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Patients must have a diagnosis of CLL/SLL or B-cell prolymphocytic leukemia, as defined by the World Health Organization (WHO) - Patients must have received at least one prior therapy, need additional cytoreduction, and meet criteria for relapsed or refractory disease; relapsed disease is defined as a patient who previously achieved a CR or a PR, but after a period of six or more months demonstrates evidence of disease progression; refractory disease is defined as progression within six months of the last anti-leukemic therapy, or any response less than a CR or PR - Patients may have not received treatment for 28 days before the first day of the study protocol - Estimated life expectancy greater than two months - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Ability to understand and willingness to sign a written informed consent document - Absolute neutrophil count (ANC) >= 750 cells/uL (0.75 x 10^9/L) - Platelets >= 30,000 cells/uL (30 x 10^9/L) - Total bilirubin =< 1.5 x upper limit of normal (ULN) unless Gilbert's syndrome or disease infiltration of the liver is present - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.0 x ULN - Creatinine < 2.0 x ULN or creatinine clearance (estimated [est.] glomerular filtration rate [GFR] [Cockcroft-Gault]) >= 30 mL/min - Females of childbearing potential (FCBP) must have a negative pregnancy test (sensitivity of at least 25 mIU/mL) performed once before ibrutinib and a total of two negative tests before initiating lenalidomide; the pre- ibrutinib test will be initiated at enrollment; the first pre-lenalidomide test will be performed within 10-14 days of starting lenalidomide (course 0, day 15), and the second pre- lenalidomide test (3rd total test) will be within 24 hours of study entry; the patient may not receive lenalidomide until the study doctor has verified that the results of these pregnancy tests are negative; pregnancy tests (if applicable) are then to be conducted weekly during the first month, and monthly thereafter in women with a regular menstrual cycle, as well as at study discontinuation, and at day 28 following study discontinuation; if menstrual cycles are irregular, pregnancy testing will be conducted weekly for the first month, and then every 14 days while on the study, at study discontinuation, and at days 14 and 28 following study drug discontinuation; pregnancy testing and counseling are to be performed if a patient misses her period or if there is any abnormality in menstrual bleeding; further, FCBP must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure

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Contact information

Primary Contact:

Asma Khan 650-724-6008

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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