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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/NCT04804254
Registration number
NCT04804254
Ethics application status
Date submitted
16/03/2021
Date registered
18/03/2021
Date last updated
3/02/2023
Titles & IDs
Public title
Study to Evaluate Adverse Events, Change in Disease Activity, Movement of Oral ABBV-623 and ABBV-992 Tablets in the Body of Adult Participants With B-cell Cancers
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Scientific title
A Phase 1 First-in-Human, Multicenter, Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of ABBV-623 and ABBV-992 in Subjects With B-cell Malignancies
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Secondary ID [1]
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2020-005196-12
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Secondary ID [2]
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M20-208
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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:
B-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 - ABBV-623
Treatment: Drugs - ABBV-992
Experimental: Monotherapy in Dose Escalation: ABBV-623 - Participants with Relapsed/Refractory (R/R) B-cell malignancies will receive escalating doses of ABBV-623.
Experimental: Monotherapy in Dose Escalation: ABBV-992 - Participants with R/R B-cell malignancies will receive escalating doses of ABBV-992.
Experimental: Combination in Dose Escalation - Participants with R/R B-cell malignancies will receive escalating doses of ABBV-623 and ABBV-992.
Experimental: Monotherapy in Dose Expansion: ABBV-623 - Participants with R/R B-cell malignancies will receive ABBV-623 at recommended Phase 2 dose (RP2D) determined in dose escalation phase.
Experimental: Monotherapy in Dose Expansion: ABBV-992 - Participants with R/R B-cell malignancies will receive ABBV-992 at recommended Phase 2 dose (RP2D) determined in dose escalation phase.
Experimental: Combination in Dose Expansion - Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) will receive ABBV-623 and ABBV-992 at recommended Phase 2 dose (RP2D) determined in dose escalation phase.
Treatment: Drugs: ABBV-623
Oral Tablets
Treatment: Drugs: ABBV-992
Oral Tablets
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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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Percentage of Participants With Adverse Events (AEs)
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Assessment method [1]
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An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product 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.
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Timepoint [1]
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Up to approximately 25 months.
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Primary outcome [2]
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Dose Escalation: Maximum Observed Plasma Concentration (Cmax) of ABBV-623
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Assessment method [2]
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The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that ABBV-623 achieves in the blood after administration in a dosing interval.
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Timepoint [2]
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Up to approximately 96 weeks
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Primary outcome [3]
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Dose Escalation: Area Under the Plasma Concentration- Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration of ABBV-623
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Assessment method [3]
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The area under the plasma concentration-time curve (AUC; measured in h*ng/mL/mg) is a method of measurement of the total exposure of ABBV-623 in blood plasma.
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Timepoint [3]
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Up to approximately 96 weeks
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Primary outcome [4]
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Dose Escalation: Maximum Observed Plasma Concentration (Cmax) of ABBV-992
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Assessment method [4]
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The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that ABBV-992 achieves in the blood after administration in a dosing interval.
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Timepoint [4]
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Up to approximately 96 weeks.
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Primary outcome [5]
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Dose Escalation: Area Under the Plasma Concentration- Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration of ABBV-992
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Assessment method [5]
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The area under the plasma concentration-time curve (AUC; measured in h*ng/mL/mg) is a method of measurement of the total exposure of ABBV-992 in blood plasma.
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Timepoint [5]
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Up to approximately 96 weeks
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Primary outcome [6]
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Combination Dose Expansion: Overall Response Rate (ORR) (PR or Better by IWCLL Criteria) in Participants With R/R CLL/SLL
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Assessment method [6]
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ORR is the proportion of R/R CLL/SLL participants achieving a response of PR or better per IWCLL without the use of new anti-cancer therapy.
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Timepoint [6]
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Up to approximately 2 years
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Secondary outcome [1]
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Dose Escalation in Participants With R/R B-cell Malignancies: Percentage of Participants Achieving a Response of Partial Response (PR) or Better per Disease-Specific Response Criteria (e.g., IWCLL, Lugano, IWWM)
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Assessment method [1]
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Partial response (PR) as per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) , Lugano, International Workshop on Waldenström's Macroglobulinemia (IWWM) criteria in protocol.
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Timepoint [1]
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Up to approximately 2 years
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Secondary outcome [2]
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Dose Escalation in Participants With R/R B-cell Malignancies: Duration of Response (DOR) for Participants With a Response of PR or Better
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Assessment method [2]
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Duration of Response (DOR) is defined as the time from the date of the participant's documented first response of PR or better to the date of documented disease progression or death due to the disease, whichever occurs first.
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Timepoint [2]
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Up to approximately 2 years
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Secondary outcome [3]
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Dose Escalation in Participants With R/R B-cell Malignancies: Time to Response (TTR)
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Assessment method [3]
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Time to response, defined as the length of time from the date of first dose of study drug to the date of first response of PR or better per disease-specific response criteria.
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Timepoint [3]
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Up to approximately 2 years
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Secondary outcome [4]
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Monotherapy Dose Expansion in Participants With R/R B-cell Malignancies: Achievement of a Response of PR or Better
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Assessment method [4]
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Partial response (PR) as per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) , Lugano, International Workshop on Waldenström's Macroglobulinemia (IWWM) criteria in protocol.
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Timepoint [4]
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Up to approximately 2 years
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Secondary outcome [5]
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Monotherapy Dose Expansion in Participants With R/R B-cell Malignancies: Duration of Response (DOR) for Participants With a Response of PR or Better
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Assessment method [5]
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Duration of Response (DOR) is defined as the time from the date of the participant's documented first response of PR or better to the date of documented disease progression or death due to the disease, whichever occurs first.
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Timepoint [5]
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Up to approximately 2 years
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Secondary outcome [6]
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Monotherapy Dose Expansion in Participants With R/R B-cell Malignancies: Time to Response (TTR)
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Assessment method [6]
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Time to response, defined as the length of time from the date of first dose of study drug to the date of first response of PR or better per disease-specific response criteria.
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Timepoint [6]
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Up to approximately 2 years
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Secondary outcome [7]
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Combination Dose Expansion in Participants With CLL/SLL: Achievement of Bone Marrow Undetectable Minimal Residual Disease (uMRD)
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Assessment method [7]
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Undetectable minimal residual disease (uMRD) is described as less than one myeloma cell per million bone marrow cells.
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Timepoint [7]
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Up to approximately 6 months
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Secondary outcome [8]
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Combination Dose Expansion in Participants With CLL/SLL: Achievement of Bone Marrow Undetectable Minimal Residual Disease (uMRD)
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Assessment method [8]
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Undetectable minimal residual disease (uMRD) is described as less than one myeloma cell per million bone marrow cells.
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Timepoint [8]
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Up to approximately 1 Year
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Secondary outcome [9]
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Combination Dose Expansion in Participants With CLL/SLL: Percentage of Participants With Achievement of Peripheral Blood uMRD
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Assessment method [9]
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Peripheral blood Undetectable minimal residual disease (uMRD) is described as less than one CLL cell per 10,000 leukocytes (or below 10^-4) or as specified in the protocol.
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Timepoint [9]
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Up to approximately 96 weeks
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Secondary outcome [10]
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Combination Dose Expansion in Participants With CLL/SLL: Duration of Response for Participants With a Response of PR or Better
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Assessment method [10]
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Duration of response is defined as the time from the initial objective response to disease progression or death, whichever occurs first.
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Timepoint [10]
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Up to approximately 2 years
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Secondary outcome [11]
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Combination Dose Expansion in Participants With CLL/SLL: Time to Response
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Assessment method [11]
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Time to response is defined by the time between the date of the first drug intake and the date of the first assessment having documented the response.
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Timepoint [11]
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Up to approximately 2 years
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Secondary outcome [12]
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Combination Dose Expansion in Participants with CLL/SLL: Progression Free Survival
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Assessment method [12]
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Progression free survival (PFS) is defined as the duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first.
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Timepoint [12]
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Approximately 2 years after study drug discontinuation
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Secondary outcome [13]
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Combination Dose Expansion in Participants With CLL/SLL: Overall Survival
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Assessment method [13]
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Overall Survival is defined as the number of days from the date the participant was randomized to the date of death.
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Timepoint [13]
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Approximately 2 years after study drug discontinuation
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Eligibility
Key inclusion criteria
- Participants must have documented diagnosis for one of the following B-cell
malignancies: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL),
Mantle Cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), Waldenström's
macroglobulinemia (WM), diffuse large B-cell lymphoma (DLBCL), and follicular lymphoma
(FL), with measurable disease requiring treatment.
- Participants have relapsed or refractory to at least 2 prior systemic therapies.
- Combination Dose Expansion Only: Participants with documented diagnosis of CLL/SLL
with measurable disease requiring treatment per by International Workshop on Chronic
Lymphocytic Leukemia (IWCLL) criteria.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- CLL/SLL, MCL, WM, MZL only: Prior Bruton's tyrosine kinase inhibitor (BTKi) exposure
will be allowed if participant did not progress on active treatment and there is no
evidence of resistance mutations.
- Renal, liver and hematological function lab values as determined in the protocol.
- For participants with prior BTK inhibitor exposure, no evidence of mutations which
confer resistance to covalent BTK inhibitors.
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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
- Participants with indolent forms of non-Hodgkin lymphoma (NHL) that require immediate
cytoreduction.
- Participants with prior B-cell lymphoma 2 (BCL2) inhibitor (BCL2i) exposure (except
for participants in the ABBV-992 monotherapy cohort).
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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
Terminated
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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
27/04/2021
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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
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Actual
11/01/2023
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Sample size
Target
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Accrual to date
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Final
5
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Israel
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State/province [1]
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Tel-Aviv
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Country [2]
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Puerto Rico
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State/province [2]
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San Juan
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Country [3]
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Turkey
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State/province [3]
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Ankara
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Country [4]
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Turkey
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State/province [4]
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Izmir
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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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
B-cell cancer is an aggressive and rare cancer of a type of immune cells (a white blood cell
responsible for fighting infections). The main objective of this study is to evaluate the
safety and efficacy of ABBV-623 and ABBV-992 given alone and in combination in treating
B-cell cancers. Adverse events, change in disease activity and how the drug moves through the
body of adult participants with B-cell cancers will be evaluated.
ABBV-623 and ABBV-992 are investigational drugs being developed for the treatment of B-cell
cancer. Study doctors assign participants to one of six groups, called treatment arms.
Approximately 105 adult participants with a diagnosis of B-cell cancer will be enrolled in
the study at approximately 50 sites worldwide.
Participants in the combination expansion treatment arms will receive oral tablets of
ABBV-623 and/or ABBV-992 once daily for 24 months. All other arms are treated until
progression.
Participants will attend regular visits during the study at a hospital or clinic. The effect
of treatment will be evaluated by medical assessments and blood tests. Adverse events will be
collected and assessed throughout the clinical trial.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04804254
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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ABBVIE INC.
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Address
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AbbVie
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04804254
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