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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03960840
Registration number
NCT03960840
Ethics application status
Date submitted
21/05/2019
Date registered
23/05/2019
Titles & IDs
Public title
Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, ALL and 1L HR LBCL
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Scientific title
Phase I/II, Open Label, Multicenter Study of Rapcabtagene Autoleucel in Adult Patients With CLL/SLL, 3L+ DLBCL, ALL and 1L HR LBCL
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Secondary ID [1]
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0
CYTB323A12101
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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:
Chronic Lymphocytic Leukemia
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0
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Small Lymphocytic Lymphoma
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0
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Diffuse Large B-cell Lymphoma
0
0
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Acute Lymphoblastic Leukemia
0
0
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Large B-cell Lymphoma
0
0
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Condition category
Condition code
Cancer
0
0
0
0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
0
0
0
0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
0
0
0
0
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Leukaemia - Acute leukaemia
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Cancer
0
0
0
0
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Leukaemia - Chronic leukaemia
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Cancer
0
0
0
0
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Rapcabtagene autoleucel single agent
Treatment: Drugs - Ibrutinib
Experimental: CLL/SLL - Dose escalation and expansion of rapcabtagene autoleucel in combination with ibrutinib
Experimental: 3L+ DLBCL - Dose escalation and expansion of rapcabtagene autoleucel single agent in 3L+ DLBCL
Experimental: Adult ALL - Dose escalation and expansion of rapcabtagene autoleucel single agent in adult ALL
Experimental: 1L HR LBCL - Rapcabtagene autoleucel single agent in 1L HR LBCL
Treatment: Other: Rapcabtagene autoleucel single agent
Single infusion of rapcabtagene autoleucel
Treatment: Drugs: Ibrutinib
Tablets or capsules for oral daily use
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Intervention code [1]
0
0
Treatment: Other
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Intervention code [2]
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0
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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Phase 1: Dose recommendation: Incidence and nature of Dose Limiting Toxicities (Dose Escalation part only)
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Assessment method [1]
0
0
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Timepoint [1]
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28 days
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Primary outcome [2]
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0
Phase 1: Safety: Incidence and severity of AEs and SAEs, including changes in laboratory values, ECG and vital signs
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Assessment method [2]
0
0
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Timepoint [2]
0
0
24 months
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Primary outcome [3]
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0
Phase 1: Tolerability: Ibrutinib dose modifications in the CLL/SLL arm
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Assessment method [3]
0
0
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Timepoint [3]
0
0
24 months
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Primary outcome [4]
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0
Phase 1: Manufacture success: Number of patients infused with planned target dose
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Assessment method [4]
0
0
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Timepoint [4]
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0
24 months
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Primary outcome [5]
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0
Phase 2: Complete Response Rate (CRR) as assessed by local Investigator
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Assessment method [5]
0
0
CRR defined as best overall response (BOR) of CR after rapcabtagene autoleucel infusion as per Lugano criteria for 3L+ Diffuse Large B-Cell Lymphoma (DLBCL) and 1L High Risk Large B-Cell (HR LBCL)
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Timepoint [5]
0
0
24 months
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Secondary outcome [1]
0
0
Phase 1: Complete Response (CR)/Partial Response (CR) in CLL/SLL
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Assessment method [1]
0
0
per international workshop on Chronic Lymphocytic Leukemia (iwCLL) response criteria
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Timepoint [1]
0
0
24 months
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Secondary outcome [2]
0
0
Phase 1: BOR of CR/PR per Lugano criteria in 3L+ DLBCL
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Assessment method [2]
0
0
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Timepoint [2]
0
0
24 months
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Secondary outcome [3]
0
0
Phase 1: Duration of response (DOR) in CLL/SLL and 3L+ DLBCL
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Assessment method [3]
0
0
DOR as assessed by time from first achievement of CR/PR after rapcabtagene autoleucel infusion until first documented disease progression or death due to any cause
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Timepoint [3]
0
0
24 months
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Secondary outcome [4]
0
0
Phase 1: BOR in ALL as assessed by an Independent Review Committee (IRC)
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Assessment method [4]
0
0
BOR of CR/CRi by 3 months after rapcabtagene autoleucel infusion as per IRC assessment.
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Timepoint [4]
0
0
month 3
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Secondary outcome [5]
0
0
Phase 1: DOR in ALL as assessed by an Independent Review Committee
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Assessment method [5]
0
0
DOR, defined as the time from achievement of CR or CRi to relapse or death due to any cause
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Timepoint [5]
0
0
24 months
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Secondary outcome [6]
0
0
Phase 1: EFS in ALL as assessed by an Independent Review Committee
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Assessment method [6]
0
0
EFS, defined as the date from rapcabtagene autoleucel infusion to the earliest date of relapse after CR/CRi, treatment failure (defined as failure to achieve CR/CRi within 12 weeks of infusion), or death due to any cause
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Timepoint [6]
0
0
24 months
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Secondary outcome [7]
0
0
Phase 1: BOR in ALL as assessed by local Investigator
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Assessment method [7]
0
0
BOR of CR/CRi
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Timepoint [7]
0
0
24 months
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Secondary outcome [8]
0
0
Phase 1: DOR in ALL as assessed by local Investigator
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Assessment method [8]
0
0
DOR, defined as the time from achievement of CR or CRi to relapse or death due to any cause.
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Timepoint [8]
0
0
24 months
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Secondary outcome [9]
0
0
Phase 1: EFS in ALL as assessed by local Investigator
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Assessment method [9]
0
0
EFS, defined as the date from rapcabtagene autoleucel infusion to the earliest date of relapse after CR/CRi, treatment failure (defined as failure to achieve CR/CRi within 12 weeks of infusion), or death due to any cause
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Timepoint [9]
0
0
24 months
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Secondary outcome [10]
0
0
Phase 1: Overall survival in adult ALL
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Assessment method [10]
0
0
OS defined as time from the date of infusion to the date of death due to any reason
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Timepoint [10]
0
0
24 months
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Secondary outcome [11]
0
0
Phase 1: MRD negative status by flow cytometry in adult ALL
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Assessment method [11]
0
0
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Timepoint [11]
0
0
24 months
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Secondary outcome [12]
0
0
Phase 1: Quality of life in adult ALL patients enrolled in the expansion part by use of Electronic Patient Reported Outcomes (ePRO) as per EORTC QLQ-C30 questionnaire
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Assessment method [12]
0
0
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Timepoint [12]
0
0
24 months
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Secondary outcome [13]
0
0
Phase 1: Quality of life in adult ALL patients enrolled in the expansion part by use of Electronic Patient Reported Outcomes (ePRO) as per EQ-5D-3 questionnaire
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Assessment method [13]
0
0
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Timepoint [13]
0
0
24 months
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Secondary outcome [14]
0
0
Phase 1/2: Cellular kinetics
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Assessment method [14]
0
0
CAR transgene levels by quantitative polymerase chain reaction (qPCR) in peripheral blood, bone marrow and lymph nodes
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Timepoint [14]
0
0
24 months
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Secondary outcome [15]
0
0
Phase 1/2: Immunogenicity
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Assessment method [15]
0
0
Cellular and humoral responses to the CAR transgene
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Timepoint [15]
0
0
24 months
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Secondary outcome [16]
0
0
Phase 2: Overall response rate (ORR)
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Assessment method [16]
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ORR defined as BOR of CR/PR as per Lugano criteria in 3L+ DLBCL and 1L HR LBCL
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Timepoint [16]
0
0
24 months
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Secondary outcome [17]
0
0
Phase 2: Complete Response Rate (CRR)
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Assessment method [17]
0
0
CRR at months 3, 6 in 3L+ DLBCL
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Timepoint [17]
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0
months 3, 6
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Secondary outcome [18]
0
0
Phase 2: Complete Response Rate (CRR)
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Assessment method [18]
0
0
CRR at months 6, 12 in 1L HR LBCL
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Timepoint [18]
0
0
months 6, 12
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Secondary outcome [19]
0
0
Phase 2: Duration of response (DOR)
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Assessment method [19]
0
0
DOR defined as time from first CR/PR to first documented progression or death due to any cause in 3L+ DLBCL and 1L HR LBCL
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Timepoint [19]
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0
24 months
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Secondary outcome [20]
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0
Phase 2: Progression-free survival (PFS)
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Assessment method [20]
0
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PFS defined as time from rapcabtagene autoleucel infusion to first documented progression or death due to any cause in 3L+ DLBCL and 1L HR LBCL
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Timepoint [20]
0
0
24 months
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Secondary outcome [21]
0
0
Phase 2: Event-free survival (EFS)
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Assessment method [21]
0
0
EFS defined as time from rapcabtagene autoleucel infusion to first documented progression, start of new anti-lymphoma therapy, biopsy-proven residual disease on or after month 6, or death due to any cause in 1L HR LBCL
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Timepoint [21]
0
0
24 months
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Secondary outcome [22]
0
0
Phase 2: Overall survival (OS)
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Assessment method [22]
0
0
OS defined as time from date of rapcabtagene autoleucel infusion to date of death due to any cause in 3L+ DLBCL and 1L HR LBCL
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Timepoint [22]
0
0
24 months
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Secondary outcome [23]
0
0
Phase 2: Complete Response Rate (CRR) in subgroups 1) IPI 4-5 or DH/TH and 2) IPI 3 and not DH/TH
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Assessment method [23]
0
0
CRR at months 6, 12 in 1L HR LBCL
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Timepoint [23]
0
0
months 6, 12
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Secondary outcome [24]
0
0
Phase 2: Overall response rate (ORR) in subgroups 1) IPI 4-5 or DH/TH and 2) IPI 3 and not DH/TH
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Assessment method [24]
0
0
ORR defined as BOR of CR/PR as per Lugano criteria 1L HR LBCL
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Timepoint [24]
0
0
24 months
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Secondary outcome [25]
0
0
Phase 2: Duration of response (DOR) in subgroups 1) IPI 4-5 or DH/TH and 2) IPI 3 and not DH/TH
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Assessment method [25]
0
0
DOR defined as time from first CR/PR to first documented progression or death due to any cause in 1L HR LBCL
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Timepoint [25]
0
0
24 months
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Secondary outcome [26]
0
0
Phase 2: Progression-free survival (PFS) in subgroups 1) IPI 4-5 or DH/TH and 2) IPI 3 and not DH/TH
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Assessment method [26]
0
0
PFS defined as time from rapcabtagene autoleucel infusion to first documented progression or death due to any cause in 1L HR LBCL
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Timepoint [26]
0
0
24 months
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Secondary outcome [27]
0
0
Phase 2: Event-free survival (EFS) in subgroups 1) IPI 4-5 or DH/TH and 2) IPI 3 and not DH/TH
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Assessment method [27]
0
0
EFS defined as time from rapcabtagene autoleucel infusion to first documented progression, start of new anti-lymphoma therapy, biopsy-proven residual disease on or after month 6, or death due to any cause in 1L HR LBCL
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Timepoint [27]
0
0
24 months
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Secondary outcome [28]
0
0
Phase 2: Overall survival (OS) in subgroups 1) IPI 4-5 or DH/TH and 2) IPI 3 and not DH/TH
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Assessment method [28]
0
0
OS defined as time from date of rapcabtagene autoleucel infusion to date of death due to any cause in 1L HR LBCL
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Timepoint [28]
0
0
24 months
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Secondary outcome [29]
0
0
Phase 2: Manufacturing vein to door time
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Assessment method [29]
0
0
Time from apheresis completion until return of rapcabtagene autoleucel product to the clinic or hospital
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Timepoint [29]
0
0
24 months
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Eligibility
Key inclusion criteria
* ECOG performance status 0-1
* CLL or SLL diagnosis according to iwCLL criteria
* CLL/SLL in SD or PR after at least 6 months of ibrutinib, either as second or subsequent line of therapy
* DLBCL diagnosis by local histopathology
* DLBCL relapsed or refractory after 2 or more lines of therapy, including autologous hematopoietic stem cell transplantation (HSCT)
* Refractory or relapsed CD19-positive ALL
* ALL with morphologic disease in the bone marrow
1L HR LBCL - Considered to be high-risk based on at least 1 of the following at diagnosis:
* IPI score of 3, 4 or 5
* MYC and BCL2 and/or BCL6 rearrangement (DH/THL)
* Participants must have received 2 cycles of frontline therapy for LBCL with R-CHOP or Pola-R-CHP or DA-EPOCH-R. Participants with DH/TH lymphoma must have received DA-EPOCH-R.
* Participants must have a positive PET per Lugano classification (Deauville PET score of 4 or 5 and an overall response of PR/SD) after 2 cycles of frontline CIT. Note: Patient's with Deauville PET score of 5 and overall response of PD, or with Deauville PET score of 1, 2, or 3 and overall response of CR, are not eligible for this trial.
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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
* Prior CD19-directed therapy
* Prior administration of a genetically engineered cellular product
* Prior allogeneic HSCT
* Richter's transformation
* For 1L HR LBCL: Richter's transformation, Burkitt lymphoma, primary DLBCL of CNS, DLBCL associated with chronic inflammation, intravascular large B-cell lymphoma, ALK- positive large B-cell lymphoma, HHV8 positive LBCL, DLBCL leg type or EBV positive DLBCL, NOS.
* Active CNS lymphoma
* For 1L HR LBCL: Active CNS involvement by malignancy
* Targeted small molecule or kinase inhibitor within 2 weeks from leukapheresis
Other protocol-defined inclusion/exclusion may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
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
26/06/2019
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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
30/06/2027
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Actual
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Sample size
Target
225
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
0
0
Novartis Investigative Site - Melbourne
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Recruitment postcode(s) [1]
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0
3000 - Melbourne
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Recruitment postcode(s) [2]
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0
3004 - Melbourne
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Florida
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Georgia
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Illinois
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Kansas
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Massachusetts
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Country [7]
0
0
United States of America
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State/province [7]
0
0
New York
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Pennsylvania
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Tennessee
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Texas
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Wisconsin
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Country [12]
0
0
Austria
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State/province [12]
0
0
Wien
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Country [13]
0
0
France
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State/province [13]
0
0
Marseille
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Country [14]
0
0
France
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State/province [14]
0
0
Paris 10
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Country [15]
0
0
France
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State/province [15]
0
0
Pierre Benite
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Country [16]
0
0
Germany
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State/province [16]
0
0
Essen
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Country [17]
0
0
Germany
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State/province [17]
0
0
Frankfurt
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Country [18]
0
0
Germany
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State/province [18]
0
0
Koeln
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Country [19]
0
0
Germany
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State/province [19]
0
0
Leipzig
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Country [20]
0
0
Italy
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State/province [20]
0
0
BG
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Country [21]
0
0
Italy
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State/province [21]
0
0
BO
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Country [22]
0
0
Italy
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State/province [22]
0
0
MI
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Country [23]
0
0
Japan
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State/province [23]
0
0
Fukuoka
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Country [24]
0
0
Japan
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State/province [24]
0
0
Hokkaido
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Country [25]
0
0
Japan
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State/province [25]
0
0
Tokyo
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Country [26]
0
0
Spain
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State/province [26]
0
0
Andalucia
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Country [27]
0
0
Spain
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State/province [27]
0
0
Castilla Y Leon
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Country [28]
0
0
Spain
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State/province [28]
0
0
Catalunya
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Country [29]
0
0
Spain
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State/province [29]
0
0
Comunidad Valenciana
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Country [30]
0
0
Spain
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State/province [30]
0
0
Barcelona
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Country [31]
0
0
Spain
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State/province [31]
0
0
Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a phase I/II study to evaluate the feasibility, safety and preliminary antitumor efficacy of rapcabtagene autoleucel (also known as YTB323). Rapcabtagene autoleucel will be investigated in combination with ibrutinib in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and as single agent in diffuse large B-cell lymphoma (3L+ DLBCL), adult acute lymphoblastic leukemia (ALL) and 1st Line High Risk Large B-Cell Lymphoma (1L HR LBCL).
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Trial website
https://clinicaltrials.gov/study/NCT03960840
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Novartis Pharmaceuticals
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Address
0
0
Novartis Pharmaceuticals
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Novartis Pharmaceuticals
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Address
0
0
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Country
0
0
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Phone
0
0
1-888-669-6682
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03960840