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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03112174
Registration number
NCT03112174
Ethics application status
Date submitted
4/04/2017
Date registered
13/04/2017
Date last updated
28/09/2023
Titles & IDs
Public title
Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (SYMPATICO)
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Scientific title
Phase 3 Study of Ibrutinib in Combination With Venetoclax in Subjects With Mantle Cell Lymphoma
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Secondary ID [1]
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2017-000129-12
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Secondary ID [2]
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PCYC-1143-CA
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mantle-Cell Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ibrutinib
Treatment: Drugs - Venetoclax
Treatment: Drugs - Placebo Oral tablet to match Venetoclax
Experimental: Safety Run-in Period - Subjects are enrolled into the open-label Safety Run-in Period to evaluate the occurrence of tumor lysis syndrome (TLS) and DLTs with the concurrent administration of ibrutinib and venetoclax.
Safety run-in phase for the study is closed to further enrollment as of 07-Nov-2018.
Experimental: Phase 3: Ibrutinb + Venetoclax - Subjects will be randomized to receive ibrutinib and venetoclax/placebo until clinical disease progression or unacceptable toxicity
Placebo Comparator: Phase 3: Ibrutinib + Placebo - Subjects will be randomized to receive ibrutinib and venetoclax/placebo until clinical disease progression or unacceptable toxicity
Experimental: Treatment-naive - This open-label arm is designed to explore the efficacy and safety of the combination of ibrutinib and venetoclax in subjects with treatment-naive MCL.
Approximately 75 subjects (of which ~25 subjects with TP53 mutation) will be enrolled and treated with ibrutinib and venetoclax.
Treatment: Drugs: Ibrutinib
Administered orally once daily
Treatment: Drugs: Venetoclax
Administered orally once daily
Treatment: Drugs: Placebo Oral tablet to match Venetoclax
Administered orally once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Occurrence of Tumor Lysis Syndrome (TLS) (Safety Run-in Period)
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Assessment method [1]
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To evaluate the occurrence of tumor lysis syndrome (TLS) with the concurrent administration of ibrutinib and venetoclax.
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Timepoint [1]
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Approximately 3 months after last subject enrolled into safety run-in portion
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Primary outcome [2]
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Occurrence of Dose Limiting Toxicities (DLT) (Safety Run-in Period)
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Assessment method [2]
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To evaluate the occurrence of DLTs with the concurrent administration of ibrutinib and venetoclax.
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Timepoint [2]
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Approximately 3 months after last subject enrolled into safety run-in portion
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Primary outcome [3]
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Number of Participants With Adverse Events (AEs) (Safety Run-in Period)
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Assessment method [3]
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An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
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Timepoint [3]
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Up to approximately 5 years
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Primary outcome [4]
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Overall response rate (ORR) (Safety Run-in Period)
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Assessment method [4]
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ORR is defined as CR or PR per investigator assessment according to the Revised Response Criteria for Malignant Lymphoma.
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Timepoint [4]
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approximately 1 year after last subject has stopped treatment with study drug(s)
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Primary outcome [5]
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Duration of Response (DOR) (Safety Run-in Period)
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Assessment method [5]
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DOR is defined as participants who achieve an overall response as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first.
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Timepoint [5]
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Up to approximately 5 years
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Primary outcome [6]
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Progression-free Survival (PFS) (Safety Run-in Period)
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Assessment method [6]
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To evaluate PFS of ibrutinib and venetoclax compared to ibrutinib and placebo.
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Timepoint [6]
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approximately 1 year after last subject has stopped treatment with study drug(s)
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Primary outcome [7]
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Overall Survival (OS) (Safety Run-in Period)
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Assessment method [7]
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OS is defined as the time from the date of the first dose of study treatment to death from any cause.
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Timepoint [7]
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Up to approximately 5 years
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Primary outcome [8]
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Progression-free Survival (PFS) (Randomization Period)
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Assessment method [8]
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To evaluate PFS of ibrutinib and venetoclax compared to ibrutinib and placebo.
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Timepoint [8]
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approximately 1 year after last subject has stopped treatment with study drug(s)
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Primary outcome [9]
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Complete Response (CR) (Treatment-Naive Arm)
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Assessment method [9]
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To evaluate the complete response (CR) rate with the combination of ibrutinib and venetoclax in subjects with treatment-naive MCL
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Timepoint [9]
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approximately 1 year after last subject has stopped treatment with study drug(s)
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Secondary outcome [1]
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Complete Response (CR) (Randomization Period)
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Assessment method [1]
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Complete response rate (CR) based on the best overall response per investigator assessment according to the Revised Response Criteria for Malignant Lymphoma.
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Timepoint [1]
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approximately 1 year after last subject has stopped treatment with study drug(s)
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Secondary outcome [2]
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Overall response rate (ORR) (Randomization Period and Treatment-Naive Arm)
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Assessment method [2]
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ORR is defined as CR or PR per investigator assessment according to the Revised Response Criteria for Malignant Lymphoma.
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Timepoint [2]
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approximately 1 year after last subject has stopped treatment with study drug(s)
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Secondary outcome [3]
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MRD-negative remission rate in participants who achieve CR per investigator assessment (Randomization Period and Treatment-Naive Arm)
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Assessment method [3]
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MRD-negative remission is defined as undetectable MRD at documented CR in subjects who were MRD positive at screening as assessed by flow cytometry in bone marrow and/or peripheral blood, with requirement of confirmation of MRD negativity in the subsequent peripheral blood 12 weeks later.
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Timepoint [3]
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approximately 1 year after last subject has stopped treatment with study drug(s)
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Secondary outcome [4]
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Overall Survival (OS) (Randomization Period and Treatment-Naive Arm)
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Assessment method [4]
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OS is defined as the time from the date of the first dose of study treatment to death from any cause.
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Timepoint [4]
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Up to approximately 5 years
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Secondary outcome [5]
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Duration of Response (DOR) (Randomization Period and Treatment-Naive Arm)
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Assessment method [5]
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DOR is defined as participants who achieve an overall response as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first.
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Timepoint [5]
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Up to approximately 5 years
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Secondary outcome [6]
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Time to Next Treatment (TTNT) (Randomization Period and Treatment-Naive Arm)
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Assessment method [6]
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TTNT is defined as the duration from the date of randomization to the start date of any anti-lymphoma treatment subsequent to study treatment.
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Timepoint [6]
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Up to approximately 5 years
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Secondary outcome [7]
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Percentage of participants experiencing Adverse Events (Randomization Period)
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Assessment method [7]
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An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
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Timepoint [7]
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Up to approximately 5 years
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Secondary outcome [8]
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Occurrence of Tumor Lysis Syndrome (TLS) (Randomization Period)
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Assessment method [8]
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To evaluate the occurrence of tumor lysis syndrome (TLS) with the concurrent administration of ibrutinib and venetoclax.
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Timepoint [8]
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Approximately 3 months after last subject enrolled into safety run-in portion
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Secondary outcome [9]
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Cmax if Ibrutinib (Randomization Period)
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Assessment method [9]
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Cmax if Ibrutinib.
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Timepoint [9]
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Week 6
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Secondary outcome [10]
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Tmax if Ibrutinib (Randomization Period)
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Assessment method [10]
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Tmax if Ibrutinib.
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Timepoint [10]
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Week 6
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Secondary outcome [11]
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AUClast if Ibrutinib (Randomization Period)
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Assessment method [11]
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AUClast if Ibrutinib.
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Timepoint [11]
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Week 6
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Secondary outcome [12]
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Half-Life (T1/2) if Ibrutinib (Randomization Period)
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Assessment method [12]
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Half-Life (T1/2) if Ibrutinib.
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Timepoint [12]
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Week 6
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Secondary outcome [13]
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Cmax of Venetoclax (Randomization Period)
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Assessment method [13]
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Cmax of Venetoclax.
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Timepoint [13]
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Week 6
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Secondary outcome [14]
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Tmax of Venetoclax (Randomization Period)
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Assessment method [14]
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Tmax of Venetoclax.
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Timepoint [14]
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Week 6
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Secondary outcome [15]
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AUC of Venetoclax (Randomization Period)
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Assessment method [15]
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AUC of Venetoclax.
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Timepoint [15]
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Week 6
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Secondary outcome [16]
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Time to worsening in FACT-Lym subscale of the health-related quality of life (Randomization Period) questionnaire (FACT-Lym)
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Assessment method [16]
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Time to worsening in FACT-Lym subscale of the health-related quality of life questionnaire (FACT-Lym) will be compared between treatment arms.
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Timepoint [16]
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Week 6
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Secondary outcome [17]
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Duration of CR (Treatment-Naive Arm Period)
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Assessment method [17]
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Duration of CR, defined for subjects who achieve CR as the time from the first occurrence of CR to disease progression or death, whichever occurs first.
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Timepoint [17]
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Up to approximately 5 years
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Secondary outcome [18]
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Progression-free Survival (PFS) (Treatment-Naive Arm Period)
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Assessment method [18]
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To evaluate PFS of ibrutinib and venetoclax compared to ibrutinib and placebo.
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Timepoint [18]
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approximately 1 year after last subject has stopped treatment with study drug(s)
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Eligibility
Key inclusion criteria
Relapsed/Refractory Arm
- 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 (CT/PET).
- At least 1, but no more than 5, prior treatment regimens for MCL.
- 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, hepatic and renal function.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of <= 2.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- History or current evidence of central nervous system lymphoma.
- 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 or strong CYP3A
inducers.
Treatment Naïve Arm
Inclusion Criteria:
- 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).
- Men and women =18 years of age with a TP53 mutation.
- At least 1 measurable site of disease.
- Must have adequate fresh or paraffin-embedded tissue.
- Eastern Cooperative Oncology Group (ECOG) performance status score 0-2.
- Adequate hematologic, hepatic, and renal function.
- Blastoid variant of MCL
- History or current evidence of CNS lymphoma.
- Concurrent enrollment in another therapeutic investigational study or prior therapy
including ibrutinib or other BTK inhibitors.
- Prior treatment with venetoclax or other BCL2 inhibitors.
- Vaccinated with live, attenuated vaccines within 4 weeks of the first dose of study
drug.
- Clinically significant infection requiring IV systemic treatment that was completed
<=14 days before the first dose of study drug.
- Any uncontrolled active systemic infection.
- Known bleeding disorders (eg, von Willebrand's disease or hemophilia).
- History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
- History of HIV or active HCV or HBV.
- Major surgery within 4 weeks of the first dose of study drug.
- Any life-threatening illness, medical condition, or organ system dysfunction that, in
the investigator's opinion, could compromise the participant's safety or put the study
outcomes at undue risk.
- Currently active, clinically significant cardiovascular disease; or a history of
myocardial infarction, unstable angina, or acute coronary syndrome within 6 months
prior to randomization.
- 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.
- 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 or moderate or strong
CYP3A inducers.
- Known allergy to xanthine oxidase inhibitors and/or rasburicase for subjects with
known risk factors (as defined by high tumor burden and/or diminished renal function,
as detailed in "Study Design" section above) for TLS.
- Chronic liver disease with hepatic impairment Child-Pugh class B or C.
- Unwilling or unable to participate in all required study evaluations and procedures.
- Known hypersensitivity to the active ingredient or other components of one or more
study drugs.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/06/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
15/11/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
352
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
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Recruitment hospital [1]
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The Canberra Hospital - Canberra
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Recruitment hospital [2]
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Border Medical Oncology Research Unit - Albury
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Recruitment hospital [3]
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Icon Cancer Care - Auchenflower
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Recruitment hospital [4]
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Austin Health - Heidelberg
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Recruitment hospital [5]
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Peter MacCallum Cancer - Melbourne
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Recruitment hospital [6]
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St.Vincent's Hospital - Melbourne
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Recruitment hospital [7]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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2605 - Canberra
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Recruitment postcode(s) [2]
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2640 - Albury
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Recruitment postcode(s) [3]
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4101 - Auchenflower
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Recruitment postcode(s) [4]
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3084 - Heidelberg
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Recruitment postcode(s) [5]
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3000 - Melbourne
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Recruitment postcode(s) [6]
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3065 - Melbourne
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Recruitment postcode(s) [7]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Florida
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Kansas
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Kentucky
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Michigan
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New York
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North Carolina
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Washington
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Belgium
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Antwerpen
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Ioánnina
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Larissa
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Patra
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Incheon
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Seoul
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pharmacyclics LLC.
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Janssen Research & Development, LLC
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Summary
Brief summary
This Phase 3 multinational, randomized, double-blind study is designed to compare the
efficacy and safety of the combination of ibrutinib and venetoclax vs. ibrutinib and placebo
in subjects with MCL.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03112174
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03112174
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