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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 doses of ABBV-319 that will be used in the next phase 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 154 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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation ABBV-319 | Experimental | 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 doses of ABBV-319 that will be used in the next phase are determined. |
|
| (ABBV-319) Diffuse Large B-cell Lymphoma (DLBCL) Participants | Experimental | Participants with R/R DLBCL will receive ABBV-319 in 21-day cycles. |
|
| (ABBV-319) Follicular Lymphoma (FL) Participants | Experimental | Participants with R/R FL will receive ABBV-319 in 21-day cycles. |
|
| (ABBV-319) Chronic Lymphocytic Leukemia (CLL) Participants | Experimental | Participants with R/R CLL will receive ABBV-319 in 21-day cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-319 | Drug | Intravenous (IV); Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 42 |
| 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. | Up to 30 Months |
| Maximum Observed Serum Concentration (Cmax) of ABBV-319 | Maximum observed serum concentration of ABBV-319. | Up to 6 Months |
| Time to Cmax (Tmax) of ABBV-319 | Time to Cmax of ABBV-319. | Up to 6 Months |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-319 | Terminal phase elimination half-life of ABBV-319. | Up to 6 Months |
| Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-319 | Area under the serum concentration versus time curve (AUC) of ABBV-319. | Up to 6 Months |
| Antidrug Antibody (ADA) | Incidence and concentration of anti-drug antibodies. | Up to 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 6 Months |
| Duration of Response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Cancer Center - Tucson /ID# 247752 | Recruiting | Tucson | Arizona | 85724 | United States | |
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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.
| Up to 6 Months |
| 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. | Up to 6 Months |
| 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. | Up to 30 Months |
| Overall survival (OS) Time | OS is defined as time from first study treatment to death due to any cause. | Up to 30 Months |
| Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232 |
| Completed |
| Miami |
| Florida |
| 33136 |
| United States |
| Allina Health System /ID# 251782 | Recruiting | Minneapolis | Minnesota | 55407-1321 | United States |
| University of Nebraska Medical Center /ID# 246715 | Recruiting | Omaha | Nebraska | 68198 | United States |
| Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246 | Recruiting | New York | New York | 10065-6007 | United States |
| Novant Health Presbyterian Medical Center /ID# 246719 | Recruiting | Charlotte | North Carolina | 28204 | United States |
| Baylor Sammons Cancer Center /ID# 247715 | Recruiting | Dallas | Texas | 75246 | United States |
| University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234 | Recruiting | San Antonio | Texas | 78229 | United States |
| Concord Repatriation General Hospital /ID# 249240 | Recruiting | Concord | New South Wales | 2139 | Australia |
| St Vincent's Hospital Melbourne /ID# 247624 | Recruiting | Fitzroy Melbourne | Victoria | 3065 | Australia |
| One Clinical Research Pty Ltd /ID# 248392 | Recruiting | Nedlands | Western Australia | 6009 | Australia |
| Cross Cancer Institute /ID# 246717 | Completed | Edmonton | Alberta | T6G 1Z2 | Canada |
| University Health Network_Princess Margaret Cancer Centre /ID# 243936 | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
| The Chaim Sheba Medical Center /ID# 254884 | Completed | Ramat Gan | Tel Aviv | 5265601 | Israel |
| Hadassah Medical Center-Hebrew University /ID# 254885 | Recruiting | Jerusalem | 91120 | Israel |
| Seoul National University Hospital /ID# 263945 | Recruiting | Seoul | Seoul Teugbyeolsi | 03080 | South Korea |
| Asan Medical Center /ID# 263220 | Recruiting | Seoul | Seoul Teugbyeolsi | 05505 | South Korea |
| Samsung Medical Center /ID# 263294 | Recruiting | Seoul | Seoul Teugbyeolsi | 06351 | South Korea |
| Hospital Universitario Marques de Valdecilla /ID# 262826 | Recruiting | Santander | Cantabria | 39008 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz /ID# 265198 | Recruiting | Madrid | 28040 | Spain |
|
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008224 | Lymphoma, Follicular |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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