Non Hodgkin Lymphoma Clinical 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)

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.

View Eligibility Criteria

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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

114

Study ID:

NCT05512390

Recruitment Status:

Recruiting

Sponsor:

AbbVie

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There are 13 Locations for this study

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University of Arizona Cancer Center - Tucson /ID# 247752
Tucson Arizona, 85724, United States
Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232
Miami Florida, 33136, United States
Allina Health System /ID# 251782
Minneapolis Minnesota, 55407, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246
New York New York, 10065, United States
Novant Health Presbyterian Medical Center /ID# 246719
Charlotte North Carolina, 28204, United States
Baylor Sammons Cancer Center /ID# 247715
Dallas Texas, 75246, United States
University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234
San Antonio Texas, 78229, United States
Concord Hospital /ID# 249240
Concord New South Wales, 2139, Australia
St Vincent's Hospital Melbourne /ID# 247624
Fitzroy Melbourne Victoria, 3065, Australia
One Clinical Research Pty Ltd /ID# 248392
Nedlands Western Australia, 6009, Australia
Princess Margaret Cancer Centre /ID# 243936
Toronto Ontario, M5G 2, Canada
The Chaim Sheba Medical Center /ID# 254884
Ramat Gan Tel-Aviv, 52656, Israel
Hadassah Medical Center-Hebrew University /ID# 254885
Jerusalem Yerushalayim, 91120, Israel

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

114

Study ID:

NCT05512390

Recruitment Status:

Recruiting

Sponsor:


AbbVie

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