NL-OMON52949RecruitingPhase 3
Phase 3 Study of Ibrutinib in Combination with Venetoclax in Subjects with Mantle Cell Lymphoma - PCYC-1143-CA
Pharmacyclics0 sites18 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 18
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •For SRI and Randomization Phase
- •Disease-Related
- •Pathologically confirmed MCL (in tumor tissue), with documentation of either
- •overexpression of cyclin D1 in association with other relevant markers (eg,
- •CD19, CD20, PAX5, CD5) or evidence of t(11;14) as assessed by cytogenetics,
- •fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR).
- •At least 1 measurable site of disease on cross-sectional imaging that is >=2.0
- •cm in the longest diameter and measurable in 2 perpendicular dimensions per CT
- •At least 1, but no more than 5, prior treatment regimens for MCL including at
- •least 1 prior rituximab/anti-CD20 containing regimen
- •Failure to achieve at least partial response (PR) with, or documented disease
- •progression after, the most recent treatment regimen
- •Subjects must have adequate fresh or paraffin embedded tissue., Laboratory
- •Adequate hematologic function
- •Adequate hepatic and renal function, Demographic
- •Men and women >= 18 years of age
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of <=2.
- •For Treatment-naive Open-label Arm:
- •1. Pathologically confirmed treatment-naive MCL (tumor tissue), with
- •documentation of either
- •overexpression of cyclin D1 in association with other relevant markers (eg,
- •CD19, CD20,
- •PAX5, CD5) or evidence of t(11;14), as assessed by cytogenetics, fluorescent in
- •hybridization (FISH), or polymerase chain reaction (PCR)
- •A report from the local laboratory is acceptable if available; however, it
- •must be reviewed
- •and approved by the central pathology laboratory to verify the above criteria
- •If the report from the local laboratory is not available, a tumor block or
- •slides must be sent
- •to the central pathology laboratory for confirmation of the MCL diagnosis prior
- •enrollment.
- •2. Men and women >=18 years of age, with a TP53 mutation
- •3. At least 1 measurable site of disease that is >=2.0 cm in the longest
- •diameter and measurable in
- •2 perpendicular dimensions per CT
- •4. Subjects must have adequate fresh or paraffin-embedded tissue
- •5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of <= 2
- •6. Adequate hematologic function independent of transfusion and growth factor
- •support for at
- •least 7 days prior to first dose, with the exception of pegylated G-CSF
- •(pegfilgrastim) and
- •darbepoeitin which require at least 14 days prior to the first dose defined as:
- •Absolute neutrophil count (ANC) >1000 cells/mm3 (1.0 x 109/L)
- •Platelet count >50,000 cells/mm3 (50 x 109/L)
- •Hemoglobin >8.0 g/dL
- •7. Adequate hepatic and renal function defined as:
- •Serum aspartate transaminase (AST) or alanine transaminase (ALT) <=3.0 x upper
- •normal (ULN)
- •Estimated Creatinine Clearance (CrCl) >=30 mL/min (Cockcroft-Gault)
- •Bilirubin <=1.5 x ULN (unless bilirubin rise is due to Gilbert*s syndrome or
- +8 more not shown
Exclusion Criteria
- •For SRI and Randomization Phase
- •Disease-Related
- •History or current evidence of central nervous system lymphoma Concurrent
- •Concurrent enrollment in another therapeutic investigational study or prior
- •therapy with ibrutinib or other BTK inhibitors
- •Prior treatment with venetoclax or other BCL2 inhibitors
- •Anticancer therapy including chemotherapy, radiotherapy, small molecule and
- •investigational agents <=21 days prior to receiving the first dose of study drug
- •Treatment with any of the following within 7 days prior to the first, dose of
- •study drug:
- •moderate or strong cytochrome P450 3A (CYP3A) inhibitors
- •moderate or strong CYP3A inducers
- •For Treatment-naive Open-label Arm:
- •1. Blastoid variant of MCL
- •2. History or current evidence of central nervous system lymphoma
- •3. Concurrent enrollment in another therapeutic investigational study or prior
- •therapy, including
- •ibrutinib or other BTK inhibitors
- •4. Prior treatment with venetoclax or other BCL2 inhibitors
- •5. History of other malignancies, except:
- •Malignancy treated with curative intent and with no known active disease
- •present for
- •>=3 years before the first dose of study drug and felt to be at low risk for
- •recurrence by
- •treating physician
- •Adequately treated non-melanoma skin cancer or lentigo maligna without
- •evidence of
- •Adequately treated carcinoma in situ without evidence of disease.
- •6. Vaccinated with live, attenuated vaccines within 4 weeks of the first dose
- •of study drug
- •7. Clinically significant infection requiring IV systemic treatment that was
- •completed <=14 days
- •before the first dose of study drug
- •8. Any uncontrolled active systemic infection
- •9. Known bleeding disorders (eg, von Willebrand*s disease or hemophilia)
- •10. History of stroke or intracranial hemorrhage within 6 months prior to
- •11. Known history of human immunodeficiency virus (HIV) or active with
- •hepatitis C virus
- •(HCV) or hepatitis B virus (HBV). Subjects who are positive for hepatitis B
- •core antibody, or
- •hepatitis C antibody must have a negative polymerase chain reaction (PCR)
- •result before
- •enrollment. Those who are hepatitis B surface antigen (HBsAg) or PCR positive
- •12. Major surgery within 4 weeks of the first dose of study drug.
- •13. Any life-threatening illness, medical condition, or organ system
- •dysfunction that, in the
- •investigator*s opinion, could compromise the subject*s safety or put the study
- •outcomes at
- •14. Currently active, clinically significant cardiovascular disease, such as
- •uncontrolled
- +15 more not shown
Investigators
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