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A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-319 Moves Through the Bodies of Adult Participants With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), or Chronic Lymphocytic Leukemia (CLL)

Primary Purpose

Diffuse Large B-Cell Lymphoma, Chronic Lymphocytic Leukemia, Follicular Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ABBV-319
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-Cell Lymphoma focused on measuring Diffuse Large B-Cell Lymphoma, Chronic Lymphocytic Leukemia, Follicular Lymphoma, Cancer, B-Cell Malignancies, ABBV-319

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • For dose escalation (Part 1) only: Participants with documented diagnosis of B-cell malignancies including those with histology based on criteria established by the World Health Organization (WHO), and measurable disease requiring treatment, as per the protocol.
  • For the relapsed or refractory diffuse large b-cell lymphoma (DLBCL), follicular lymphoma (FL), and Chronic lymphocytic leukemia (CLL) dose expansion cohorts (Part 2) only: Participants with documented diagnosis of one of the B-cell malignancies noted in the protocol with histology based on criteria established by the WHO, and measurable disease requiring treatment, as per the protocol.
  • Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Laboratory values meeting the criteria noted in the protocol.
  • For participants previously treated with a CD19-targeting therapy (eg, CD19 monoclonal antibody) a core or excision tumor biopsy subsequent to the most recent CD19-targeting therapy must be collected.
  • Participant must have measurable disease, as defined by the 2014 Lugano Classification.

Exclusion Criteria:

  • Known active central nervous system (CNS) disease, or primary CNS lymphoma.
  • Know active infection or clinically significant uncontrolled conditions as per the protocol.

Sites / Locations

  • University of Arizona Cancer Center - Tucson /ID# 247752Recruiting
  • Sylvester Comprehensive Cancer Center - University of Miami Hospital & Clinics /ID# 247232Recruiting
  • Novant Health Presbyterian Medical Center /ID# 246719Recruiting
  • Baylor Sammons Cancer Center /ID# 247715Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose Escalation ABBV-319

(ABBV-319) Diffuse Large B-cell Lymphoma (DLBCL) Participants

(ABBV-319) Follicular Lymphoma (FL) Participants

(ABBV-319) Chronic Lymphocytic Leukemia (CLL) Participants

Arm Description

Participants with relapsed or refractory (R/R) B cell lymphomas including diffuse large b-cell lymphoma (DLBCL) or follicular lymphoma (FL), and Chronic lymphocytic leukemia (CLL) will receive escalating doses of ABBV-319 in 21-day cycles, until the recommended Phase 2 dose (RP2D) is determined.

Participants with R/R DLBCL will receive ABBV-319 in 21-day cycles.

Participants with R/R FL will receive ABBV-319 in 21-day cycles.

Participants with R/R CLL will receive ABBV-319 in 21-day cycles.

Outcomes

Primary Outcome Measures

Number of Dose-Limiting Toxicities (DLT)
A DLT is defined as any adverse event (AE) for which a clear alternative cause cannot be established (eg, attributed to the disease under study, another disease, or to a concomitant medication by the study investigators or medical monitor).
Number of Participants with Adverse Events (AE)
AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Maximum Observed Serum Concentration (Cmax) of ABBV-319
Maximum observed serum concentration of ABBV-319.
Time to Cmax (Tmax) of ABBV-319
Time to Cmax of ABBV-319.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-319
Terminal phase elimination half-life of ABBV-319.
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-319
Area under the serum concentration versus time curve (AUC) of ABBV-319.
Antidrug Antibody (ADA)
Incidence and concentration of anti-drug antibodies.

Secondary Outcome Measures

Number of Participants with Response of Partial Response (PR) or Better per Disease-Specific Criteria
Number of participants with response of PR or better per disease-specific criteria.
Duration of Response (DOR)
DOR is defined for participants achieving a complete response (CR)/PR as the time from the initial response per investigator review to disease progression or death of any cause, whichever occurs earlier.
Time to Response
Time to response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR.
Progression Free Survival (PFS) Time
PFS is defined as time from first study treatment to a documented disease progression as determined by the investigator, or death due to any cause, whichever occurs earlier.
Overall survival (OS) Time
OS is defined as time from first study treatment to death due to any cause.

Full Information

First Posted
August 22, 2022
Last Updated
May 25, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT05512390
Brief Title
A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-319 Moves Through the Bodies of Adult Participants With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), or Chronic Lymphocytic Leukemia (CLL)
Official Title
A First In Human Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-319 in B-cell Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2023 (Actual)
Primary Completion Date
February 8, 2026 (Anticipated)
Study Completion Date
February 8, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-319 in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL), R/R follicular lymphoma (FL), or R/R CLL. Adverse events will be assessed. ABBV-319 is an investigational drug being developed for the treatment of R/R DLBCL, R/R FL, or R/R CLL. This study will include a dose escalation phase to determine the recommended Phase 2 dose (RP2D) of ABBV-319 and a dose expansion phase to determine the change in disease activity in participants with R/R DLBCL, R/R FL, and R/R CLL. Approximately 114 adult participants with R/R B cell lymphomas including R/R DLBCL, R/R FL, and R/R CLL will be enrolled in the study in sites world wide. In the Dose Escalation phase of the study participants will receive escalating intravenously infused doses of ABBV-319 in 21-day cycles, until the recommended Phase 2 dose is determined. In the dose expansion phase of the study participants receive intravenously infused ABBV-319 in 21-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-Cell Lymphoma, Chronic Lymphocytic Leukemia, Follicular Lymphoma
Keywords
Diffuse Large B-Cell Lymphoma, Chronic Lymphocytic Leukemia, Follicular Lymphoma, Cancer, B-Cell Malignancies, ABBV-319

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation ABBV-319
Arm Type
Experimental
Arm Description
Participants with relapsed or refractory (R/R) B cell lymphomas including diffuse large b-cell lymphoma (DLBCL) or follicular lymphoma (FL), and Chronic lymphocytic leukemia (CLL) will receive escalating doses of ABBV-319 in 21-day cycles, until the recommended Phase 2 dose (RP2D) is determined.
Arm Title
(ABBV-319) Diffuse Large B-cell Lymphoma (DLBCL) Participants
Arm Type
Experimental
Arm Description
Participants with R/R DLBCL will receive ABBV-319 in 21-day cycles.
Arm Title
(ABBV-319) Follicular Lymphoma (FL) Participants
Arm Type
Experimental
Arm Description
Participants with R/R FL will receive ABBV-319 in 21-day cycles.
Arm Title
(ABBV-319) Chronic Lymphocytic Leukemia (CLL) Participants
Arm Type
Experimental
Arm Description
Participants with R/R CLL will receive ABBV-319 in 21-day cycles.
Intervention Type
Drug
Intervention Name(s)
ABBV-319
Intervention Description
Intravenous (IV); Infusion
Primary Outcome Measure Information:
Title
Number of Dose-Limiting Toxicities (DLT)
Description
A DLT is defined as any adverse event (AE) for which a clear alternative cause cannot be established (eg, attributed to the disease under study, another disease, or to a concomitant medication by the study investigators or medical monitor).
Time Frame
Day 21
Title
Number of Participants with Adverse Events (AE)
Description
AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time Frame
Up to 30 Months
Title
Maximum Observed Serum Concentration (Cmax) of ABBV-319
Description
Maximum observed serum concentration of ABBV-319.
Time Frame
Up to 6 Months
Title
Time to Cmax (Tmax) of ABBV-319
Description
Time to Cmax of ABBV-319.
Time Frame
Up to 6 Months
Title
Terminal Phase Elimination Half-Life (t1/2) of ABBV-319
Description
Terminal phase elimination half-life of ABBV-319.
Time Frame
Up to 6 Months
Title
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-319
Description
Area under the serum concentration versus time curve (AUC) of ABBV-319.
Time Frame
Up to 6 Months
Title
Antidrug Antibody (ADA)
Description
Incidence and concentration of anti-drug antibodies.
Time Frame
Up to 6 Months
Secondary Outcome Measure Information:
Title
Number of Participants with Response of Partial Response (PR) or Better per Disease-Specific Criteria
Description
Number of participants with response of PR or better per disease-specific criteria.
Time Frame
Up to 6 Months
Title
Duration of Response (DOR)
Description
DOR is defined for participants achieving a complete response (CR)/PR as the time from the initial response per investigator review to disease progression or death of any cause, whichever occurs earlier.
Time Frame
Up to 6 Months
Title
Time to Response
Description
Time to response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR.
Time Frame
Up to 6 Months
Title
Progression Free Survival (PFS) Time
Description
PFS is defined as time from first study treatment to a documented disease progression as determined by the investigator, or death due to any cause, whichever occurs earlier.
Time Frame
Up to 30 Months
Title
Overall survival (OS) Time
Description
OS is defined as time from first study treatment to death due to any cause.
Time Frame
Up to 30 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For dose escalation (Part 1) only: Participants with documented diagnosis of B-cell malignancies including those with histology based on criteria established by the World Health Organization (WHO), and measurable disease requiring treatment, as per the protocol. For the relapsed or refractory diffuse large b-cell lymphoma (DLBCL), follicular lymphoma (FL), and Chronic lymphocytic leukemia (CLL) dose expansion cohorts (Part 2) only: Participants with documented diagnosis of one of the B-cell malignancies noted in the protocol with histology based on criteria established by the WHO, and measurable disease requiring treatment, as per the protocol. Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Laboratory values meeting the criteria noted in the protocol. For participants previously treated with a CD19-targeting therapy (eg, CD19 monoclonal antibody) a core or excision tumor biopsy subsequent to the most recent CD19-targeting therapy must be collected. Participant must have measurable disease, as defined by the 2014 Lugano Classification. Exclusion Criteria: Known active central nervous system (CNS) disease, or primary CNS lymphoma. Know active infection or clinically significant uncontrolled conditions as per the protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
University of Arizona Cancer Center - Tucson /ID# 247752
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Name
Sylvester Comprehensive Cancer Center - University of Miami Hospital & Clinics /ID# 247232
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
Novant Health Presbyterian Medical Center /ID# 246719
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Name
Baylor Sammons Cancer Center /ID# 247715
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-319 Moves Through the Bodies of Adult Participants With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), or Chronic Lymphocytic Leukemia (CLL)

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