Combination of Lenalidomide and Obinutuzumab (GA101) in patients with Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
The goal of this research study is to learn if the combination of lenalidomide and obinutuzumab can help to control CLL or SLL. The safety of this drug combination will also be studied.
Disease Group: Leukemia
Treatment Agent: Lenalidomide,Obinutuzumab
Treatment Location: Only at MDACC
Sponsor: Celgene Co,Genentech, Inc
Primary The primary end point will be overall response defined as achievement of CR or PR. Secondary The secondary end points will be safety of the combination, response according to prognostic markers at diagnosis, time to next treatment and overall survival.
IRB Review and Approval Date: 03/31/2016
Recruitment Status: Open
Projected Accrual: N/A
1) Age 18 years or older at the time of signing informed consent. Able
to understand and to provide voluntarily informed consent;
2) Have documented CLL/SLL according to NCI criteria;
3) Recurrent or refractory disease according to NCI criteria;
4) Patient are eligible if they have received one or more prior treatment;
5) ECOG performance status of 0-2 (Appendix 1);
6) Life expectancy > 6 months;
7) Adequate renal function indicated by serum creatinine less or equal to 2 mg/dl;
8) Adequate hepatic function indicated as total bilirubin less or equal to 2 mg/dl and ALT/GPT less or equal to two times the upper normal limit;
9) Disease free of prior malignancies for 3 years with exception of currently treated basal cell squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breast. Patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality received
10) No prior history of myelodysplastic syndrome or other myeloid malignancy;
11) All participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the Revlimid REMS ®;
12) Females of childbearing potential (FCBP) must have a negative serum and/or urine pregnancy test with a sensitive of at least 50 mIU/mL within 10-14 days and again within 24 hours prior to prescribe lenalidomide for cycle 1 (prescriptions must be filled within 7 days as required by Revlimid REMS®) and 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 she starts taking 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.
1) Known sensitivity to lenalidomide or other thalidomide derivatives or
2) Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood);
3) Known history of infection with Human immunodeficiency virus (HIV) or Human T Cell Leukemia Virus 1 (HTLV-1);
4) Serologic status reflecting active hepatitis B or C. Patients with hepatitis B (HBV) antibody positive but who have positivity for Hepatitis B surface antigen (HBsAg) or anti Hepatitis B core antibody (anti-HBc) and patients who are positive for anti-HCV will need to have a negative PCR (viral HBV DNA or HCV RNA) result prior to enrollment. Those who are HBsAg positive or HBV DNA positive and those who are positive for HCV (RNA) will be excluded;
5) Pregnant or breast feeding females;
6) History of tuberculosis treated within the last five years or recent exposure to tuberculosis;
7) Any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject unacceptable risk if he/she were to participate to the study;
8) Patients with a recent history of deep vein thrombosis or pulmonary embolus, in the six months prior to enrollment are not eligible for this study.
Information and next steps
For general questions about clinical trials: