Status and phase
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About
The purpose of this study is to find out if the combination of buparlisib and ibrutinib will lead to better treatment results in patients with relapsed or refractory Follicular lymphoma, (FL) Mantle cell lymphoma (MCL) or Diffuse Large B-cell lymphoma (DLBCL). The investigators are using buparlisib and ibrutinib because both drugs seem to block different proteins that allow cancer cells to keep growing. Blocking these proteins may help by making the cancer cells undergo cell death, which will stop uncontrolled tumor growth.
Enrollment
Sex
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Volunteers
Inclusion criteria
Patient is ≥ 18 years of age at the time of signing Informed Consent
Patient is able and willing to adhere to the study visit schedule and other protocol requirements
Patient has histologically confirmed diagnosis of R/R mantle cell lymphoma, follicular lymphoma or diffuse large B cell lymphoma
Patient has at least one measurable lesion (≥ 2 cm) according to Lugano Classification
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Patient has adequate bone marrow and organ function by:
Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trial. Men must agree to not donate sperm during and after the study.
° For females, these restrictions apply for 1 month after the last dose of study drug. For males, these restrictions apply for 4 months after the last dose of study drug.
Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study.
Patient is able to swallow and retain oral medications
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
37 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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