History of Changes for Study: NCT05512390

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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Study Record Versions

Version	Submitted Date	Changes
1	August 22, 2022	None (earliest Version on record)
2	May 25, 2023	Recruitment Status, Contacts/Locations, Study Status and Oversight
3	November 29, 2023	Study Status and Contacts/Locations
4	January 18, 2024	Study Status, Contacts/Locations and Eligibility
5	March 4, 2024	Study Status and Contacts/Locations

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	M22-716
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
Secondary IDs:

Study Status


Record Verification:	August 2022
Overall Status:	Not yet recruiting
Study Start:	August 27, 2022
Primary Completion:	September 7, 2026 [Anticipated]
Study Completion:	September 7, 2026 [Anticipated]

First Submitted:	August 22, 2022
First Submitted that Met QC Criteria:	August 22, 2022
First Posted:	August 23, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	August 22, 2022
Last Update Posted:	August 23, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	AbbVie
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

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.

Detailed Description:

Conditions


Conditions:	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

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1
Interventional Study Model:	Sequential Assignment
Number of Arms:	4
Masking:	None (Open Label)
Allocation:	Non-Randomized
Enrollment:	114 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Dose Escalation ABBV-319 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.	Drug: ABBV-319 Intravenous (IV); Infusion
Experimental: (ABBV-319) Diffuse Large B-cell Lymphoma (DLBCL) Participants Participants with R/R DLBCL will receive ABBV-319 in 21-day cycles.	Drug: ABBV-319 Intravenous (IV); Infusion
Experimental: (ABBV-319) Follicular Lymphoma (FL) Participants Participants with R/R FL will receive ABBV-319 in 21-day cycles.	Drug: ABBV-319 Intravenous (IV); Infusion
Experimental: (ABBV-319) Chronic Lymphocytic Leukemia (CLL) Participants Participants with R/R CLL will receive ABBV-319 in 21-day cycles.	Drug: ABBV-319 Intravenous (IV); Infusion

Outcome Measures


Primary Outcome Measures:
1.	Number of Dose-Limiting Toxicities (DLT) [ Time Frame: Day 21 ] 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).
2.	Number of Participants with Adverse Events (AE) [ Time Frame: Up to 30 Months ] 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.
3.	Maximum Observed Serum Concentration (Cmax) of ABBV-319 [ Time Frame: Up to 6 Months ] Maximum observed serum concentration of ABBV-319.
4.	Time to Cmax (Tmax) of ABBV-319 [ Time Frame: Up to 6 Months ] Time to Cmax of ABBV-319.
5.	Terminal Phase Elimination Half-Life (t1/2) of ABBV-319 [ Time Frame: Up to 6 Months ] Terminal phase elimination half-life of ABBV-319.
6.	Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-319 [ Time Frame: Up to 6 Months ] Area under the serum concentration versus time curve (AUC) of ABBV-319.
7.	Antidrug Antibody (ADA) [ Time Frame: Up to 6 Months ] Incidence and concentration of anti-drug antibodies.
Secondary Outcome Measures:
1.	Number of Participants with Response of Partial Response (PR) or Better per Disease-Specific Criteria [ Time Frame: Up to 6 Months ] Number of participants with response of PR or better per disease-specific criteria.
2.	Duration of Response (DOR) [ Time Frame: Up to 6 Months ] 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.
3.	Time to Response [ Time Frame: Up to 6 Months ] Time to response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR.
4.	Progression Free Survival (PFS) Time [ Time Frame: Up to 30 Months ] 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.
5.	Overall survival (OS) Time [ Time Frame: Up to 30 Months ] OS is defined as time from first study treatment to death due to any cause.

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
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.

Contacts/Locations


Central Contact Person:	ABBVIE CALL CENTER Telephone: 844-663-3742 Email: abbvieclinicaltrials@abbvie.com
Study Officials:	ABBVIE INC. Study Director AbbVie
Locations:	United States, Connecticut
	Yale University /ID# 248212 New Haven, Connecticut, United States, 06510
	United States, Massachusetts
	University of Massachusetts - Worcester /ID# 247229 Worcester, Massachusetts, United States, 01655
	United States, Texas
	Baylor Sammons Cancer Center /ID# 247715 Dallas, Texas, United States, 75246

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: