Skip to main content

8110 Gatehouse Road, Falls Church, VA 22042

A Randomized Phase III Study of the addition of Venetoclax to Ibrutinib and Obinutuzumab versus Ibrutinib and Obinutuzumab in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL) (EA9161)

Translate

General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT03701282

Background Information

This study seeks to determine what are the good and bad effects of a time limited administration of a targeted three drug treatment combination when compared with the more standard two drug treatment combination, which requires long-term, indefinite drug administration. Time limited administration means that you will only receive treatment for a specified period of time, rather than receiving treatment indefinitely.

This study will help to discover if this approach is better or worse than the usual approach for untreated CLL. The usual approach is defined as care most people get for CLL.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Dr.
Fairfax, VA 22031

A department of Inova Fairfax Hospital

Eligibility Information

  • Adults between the ages of 18 and 70
  • Diagnosis of CLL according to the NCI/IWCLL criteria or SLL according to the WHO criteria
  • No prior chemotherapy, BTK inhibitor therapy, venetoclax, small molecule signaling inhibitor, or monoclonal anti-body therapy for treatment of CLL or SL
  •  ECOG performance status between 0-2i
  • No deletion of 17p13 on cytogenetic analysis by FISH
  • No active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment. Patients who have a positive Coombs test but no evidence of hemolysis are NOT excluded from participation
  • No current use of corticosteroids. EXCEPTION: Low doses of steroids (< 10 mg of prednisone or equivalent dose of other steroid; inhaled steroids) used for treatment of non-hematologic medical condition (e.g. chronic adrenal insufficiency) is permitted
  • Additional eligibility in protocol.

Ineligibility Information

  • Patients must not have any of the following conditions:
    • Congestive heart failure or New York Heart Association Functional Classification III or IV congestive heart failure
    • History of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to registration
    • Recent infections requiring systemic treatment; need to have completed anti-biotic therapy >14 days before the first dose of study drug
    • Cerebral vascular accident or intracranial bleed within the last 6 months
    • Infection with known chronic, active hepatitis C.
    • Positive serology for Hepatitis B defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a Hepatitis B DNA test will be performed and, if positive the subject will be ineligible. If the Hep B DNA test is negative (i.e. viral load undetectable) then the individual is eligible. If a patient who is HBsAg negative, HBsAb negative, HBcAb positive, and Hep B DNA negative is enrolled, they should be considered for either prophylactic anti-viral therapyPregnant or breastfeeding
  • Patients are not eligible if they require treatment with a strong cytochrome P450 (CYP) 3A inhibitor.
  • Women must not be pregnant or breast-feeding since this study involves investigational agents whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown.
  • All females of childbearing potential must have a blood test within 2 weeks prior to registration to rule out pregnancy. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point , 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  • Additional ineligibility in protocol.

Additional information can be found at: https://clinicaltrials.gov/ct2/show/NCT03701282