Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/EUCTR2017-000129-12-BE
EUCTR2017-000129-12-BEActive, not recruitingPhase 1

Phase 3 Study of Ibrutinib in Combination with Venetoclax in Subjects with Mantle Cell Lymphoma

Pharmacyclics LLC0 sites362 target enrollmentStarted: September 15, 2017Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
362
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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.
  • •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 0 or 1
  • •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 situ 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 prior to enrollment
  • •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 to 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)
  • •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 limit of 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 of non hepatic origin)
  • •8. Prothrombin time (PT) or International normal ratio (INR) <1.5 x
  • •upper limit of normal (ULN) and PTT (activated partial thromboplastin
  • •time [aPTT]) <1.5 x ULN (unless abnormalities are unrelated to
  • •coagulopathy or bleeding disorder). When treated with warfarin or other
  • •vitamin K antagonists, then INR =3.0
  • •9. Male and female subjects of reproductive potential who agree to use
  • •both a highly effective method of birth control (eg, implants, injectables,
  • •combined oral contraceptives, some intrauterine devices [IUDs],
  • +2 more not shown

Exclusion Criteria

  • •For SRI and Randomization Phase
  • •Disease-Related
  • •History or current evidence of central nervous system lymphoma
  • •Concurrent Conditions
  • •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:
  • •o moderate or strong cytochrome P450 3A (CYP3A) inhibitors
  • •o 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 disease.
  • •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 will
  • •be excluded.
  • •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 undue risk
  • •14. Currently active, clinically significant cardiovascular disease, such as
  • •uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as
  • •defined by the New York Heart Association Functional Classification; or a
  • •history of myocardial infarction, unstable angina, or acute coronary
  • •syndrome within 6 months prior to randomization
  • •15. Unable to swallow capsules or tablets, or malabsorption syndrome,
  • •disease significantly affecting gastrointestinal function, or resection of
  • •the stomach or small bowel, symptomatic inflammatory bowel disease or
  • •ulcerative colitis, or partial or complete bowel obstruction
  • +10 more not shown

Investigators

Similar Trials

Active, not recruiting
Phase 1
Research study of Ibrutinib in Combination with Venetoclax in patients with Mantle Cell LymphomaMedDRA version: 20.0Level: PTClassification code 10061275Term: Mantle cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Mantle Cell Lymphoma
EUCTR2017-000129-12-NLPharmacyclics LLC362
Active, not recruiting
Phase 1
Research study of Ibrutinib in Combination with Venetoclax in patients with Mantle Cell LymphomaMantle Cell Lymphoma
EUCTR2017-000129-12-DEPharmacyclics LLC362
Active, not recruiting
Phase 1
Research study of Ibrutinib in Combination with Venetoclax in patients with Mantle Cell LymphomaMedDRA version: 20.0Level: PTClassification code 10061275Term: Mantle cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Mantle Cell Lymphoma
EUCTR2017-000129-12-CZPharmacyclics LLC362
Active, not recruiting
Phase 1
Research study of Ibrutinib in Combination with Venetoclax in patients with Mantle Cell LymphomaMedDRA version: 20.0Level: PTClassification code 10061275Term: Mantle cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Mantle Cell Lymphoma
EUCTR2017-000129-12-GBPharmacyclics LLC362
Recruiting
Phase 3
Phase 3 Study of Ibrutinib in Combination with Venetoclax in Subjects with Mantle Cell LymphomaNon-Hodgkin lymphomaMantle Cell lymphoma
NL-OMON52949Pharmacyclics18
Research study of Ibrutinib in Combination... | Clinical Trial