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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| ClinicalTrials.gov Identifier: NCT05512390 |
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Recruitment Status :
Recruiting
First Posted : August 23, 2022
Last Update Posted : November 30, 2023
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diffuse Large B-Cell Lymphoma Chronic Lymphocytic Leukemia Follicular Lymphoma | Drug: ABBV-319 | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 114 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | April 26, 2023 |
| Estimated Primary Completion Date : | February 8, 2026 |
| Estimated Study Completion Date : | February 8, 2026 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: ABBV-319
Intravenous (IV); Infusion |
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Experimental: (ABBV-319) Diffuse Large B-cell Lymphoma (DLBCL) Participants
Participants with R/R DLBCL will receive ABBV-319 in 21-day cycles.
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Drug: ABBV-319
Intravenous (IV); Infusion |
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Experimental: (ABBV-319) Follicular Lymphoma (FL) Participants
Participants with R/R FL will receive ABBV-319 in 21-day cycles.
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Drug: ABBV-319
Intravenous (IV); Infusion |
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Experimental: (ABBV-319) Chronic Lymphocytic Leukemia (CLL) Participants
Participants with R/R CLL will receive ABBV-319 in 21-day cycles.
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Drug: ABBV-319
Intravenous (IV); Infusion |
- 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).
- 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.
- Maximum Observed Serum Concentration (Cmax) of ABBV-319 [ Time Frame: Up to 6 Months ]Maximum observed serum concentration of ABBV-319.
- Time to Cmax (Tmax) of ABBV-319 [ Time Frame: Up to 6 Months ]Time to Cmax of ABBV-319.
- Terminal Phase Elimination Half-Life (t1/2) of ABBV-319 [ Time Frame: Up to 6 Months ]Terminal phase elimination half-life of ABBV-319.
- 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.
- Antidrug Antibody (ADA) [ Time Frame: Up to 6 Months ]Incidence and concentration of anti-drug antibodies.
- 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.
- 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.
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05512390
| Contact: ABBVIE CALL CENTER | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| United States, Arizona | |
| University of Arizona Cancer Center - Tucson /ID# 247752 | Recruiting |
| Tucson, Arizona, United States, 85724 | |
| United States, Florida | |
| Sylvester Comprehensive Cancer Center - University of Miami Hospital & Clinics /ID# 247232 | Recruiting |
| Miami, Florida, United States, 33136 | |
| United States, Minnesota | |
| Allina Health System /ID# 251782 | Recruiting |
| Minneapolis, Minnesota, United States, 55407-1321 | |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center-Koch Center/ ID# 249246 | Recruiting |
| New York, New York, United States, 10065-6007 | |
| United States, North Carolina | |
| Novant Health Presbyterian Medical Center /ID# 246719 | Recruiting |
| Charlotte, North Carolina, United States, 28204 | |
| United States, Texas | |
| Baylor Sammons Cancer Center /ID# 247715 | Recruiting |
| Dallas, Texas, United States, 75246 | |
| Australia, New South Wales | |
| Concord Hospital /ID# 249240 | Recruiting |
| Concord, New South Wales, Australia, 2139 | |
| Australia, Victoria | |
| St Vincent's Hospital Melbourne /ID# 247624 | Recruiting |
| Fitzroy Melbourne, Victoria, Australia, 3065 | |
| Australia, Western Australia | |
| One Clinical Research Pty Ltd /ID# 248392 | Recruiting |
| Nedlands, Western Australia, Australia, 6009 | |
| Canada, Ontario | |
| Princess Margaret Cancer Centre /ID# 243936 | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Study Director: | ABBVIE INC. | AbbVie |
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT05512390 |
| Other Study ID Numbers: |
M22-716 |
| First Posted: | August 23, 2022 Key Record Dates |
| Last Update Posted: | November 30, 2023 |
| Last Verified: | November 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
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Diffuse Large B-Cell Lymphoma Chronic Lymphocytic Leukemia Follicular Lymphoma |
Cancer B-Cell Malignancies ABBV-319 |
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Lymphoma Leukemia Lymphoma, Follicular Lymphoma, B-Cell Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Leukemia, B-Cell Chronic Disease Disease Attributes Pathologic Processes |