A Phase II Study Using Ibrutinib and Short-Course Fludarabine in Treatment-Naive CLL (NCT02514083) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Phase II Study Using Ibrutinib and Short-Course Fludarabine in Treatment-Naive CLL
United States29 participantsStarted 2015-12-09
Plain-language summary
This is a pilot phase 2 study investigating the safety and efficacy of ibrutinib combined with short-course fludarabine in previously untreated CLL patients. Ibrutinib will be given daily until disease progression or intolerable side effects occur. Fludarabine will be given in cycles 3 and 4. The primary efficacy endpoint is the rate of complete response after 6 cycles or 24 weeks. The primary safety endpoint is the rate of treatment discontinuation after 6 cycles or 24 weeks.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Men and women with histologically confirmed disease as defined by the following:
✓. Active disease as defined by at least one of the following (IWCLL consensus criteria):
✓. Treatment naive CLL/SLL patients
✓Treatment-naive CLL indicates no prior anti-CLL therapy. Anti-CLL therapy includes chemotherapies, monoclonal antibodies, and targeted agents with known or reasonably expected anti-leukemic activity.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
✓. Agreement to use acceptable methods of contraception during the study and for 90 days after the last dose of study drug if sexually active and able to bear or beget children. Female subjects of childbearing potential must have a negative serum pregnancy test upon study entry. Male and female subjects who agree to use both a highly effective method of birth control (eg, implants, injectables, combined oral contraceptives, some intrauterine devices, complete abstinence, or sterilized partner) and a barrier method (e.g. condoms, vaginal ring, sponge, etc.) during the period of therapy and for 90 days after the last dose of study drug.
✓. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
Exclusion criteria
✕. Transformed CLL, including Hodgkin and non-Hodgkin lymphoma
What they're measuring
1
Rate of Complete Response at 24 Weeks
Timeframe: 24 weeks
2
Rate of Treatment Discontinuation Within the First 24 Weeks
Timeframe: 24 weeks
Trial details
NCT IDNCT02514083
SponsorNational Heart, Lung, and Blood Institute (NHLBI)
. Active autoimmune hemolytic anemia or thrombocytopenia
✕. Known bleeding disorders
✕. Impaired hepatic function: Total bilirubin greater than or equal to 1.5 times upper limit of normal unless due to Gilbert's disease, aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than or equal to 2.5 times institutional upper limit of normal unless due to infiltration of liver, Child-Pugh class B or C
✕. Impaired renal function: estimated glomerular filtration rate (GFR) \< 30ml/min/1.73m(2) based on CKD-EPI
✕. Life-threatening illness, medical condition or organ system dysfunction which, in the investigators opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib and fludarabine, or put the study outcomes at undue risk
✕. Concomitant immunomodulatory therapy, chemotherapy, radiotherapy or experimental therapy