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Clinical Trial Finder

Search Results

Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets

Study Purpose

B-cell malignancies are a group of cancers of B lymphocytes, a type of white blood cell responsible for fighting infections. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-525 as a monotherapy. ABBV-525 is an investigational drug being developed for the treatment of B-Cell Malignancies. Study doctors put the participants in groups called treatment arms. Participants will receive ABBV-525 at different doses. Approximately 100 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), participants will receive escalating oral doses of ABBV-525. In part 2 (dose optimization), participants will receive one of two oral doses of ABBV-525, until the recommended phase 2 dose (RP2D) is determined. In part 3 (dose expansion), participants will receive the RP2D oral dose of ABBV-525. The estimated duration of the study is up to 64 months. 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 a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Dose Escalation (Part 1) Only: Participants with a documented diagnosis of one of the following third line or later of treatment (3L)+ mature B-cell malignancies, from the World Health Organization (WHO)-defined histologies as defined in the protocol.
  • - Dose Optimization (Part 2) Only: Participants with documented diagnosis of chronic lymphocytic leukemia (CLL) who are 3L+, +/- cysteine-to-serine point mutation at residue 481 of BTK-domain active site (C481S with histology based on WHO criteria, with measurable disease requiring treatment as defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL).
  • - Dose Expansion (Part 3) Only: Participants with documented diagnosis of non-germinal center B cell (GCB) Diffuse large B-cell lymphoma (DLBCL) who are 3L+ chimeric antigen receptor T-cells (CAR-T)/Hematopoietic cell transplant (HCT) relapsed/refractory (R/R) and/or ineligible with histology based on WHO criteria, with measurable disease requiring treatment.
  • - Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
  • - Participant has a life expectancy >= 12 weeks.
  • - Adequate hematological and hepatic function as defined in the protocol.
  • - Must have archival or freshly collected tumor tissue for correlative studies before study enrollment.
  • - Participants with prior central nervous system (CNS) disease that has been effectively treated may be eligible.
  • - Participants with resolved coronavirus disease 2019 (COVID-19) infection are eligible.

Exclusion Criteria:

  • - Known active CNS disease, or primary CNS lymphoma.
  • - Known bleeding disorders.
  • - Known history of stroke or intracranial hemorrhage within 12 months prior to first dose of study treatment.
  • - Uncontrolled active systemic infection, or active cytomegalovirus infection.
  • - Active hepatitis B or C infection.
  • - Known history of human immunodeficiency virus (HIV).
  • - Known active COVID-19 infection.
Participant must not have signs/symptoms associated with COVID-19 infection or known exposure to a confirmed case of COVID-19 infection during screening. If participant has signs/symptoms suggestive of COVID-19 infection, the participant must have a negative molecular (eg, polymerase chain reaction) test or 3 negative antigen test results at least 24 hours apart.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05618028
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AbbVie
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

ABBVIE INC.
Principal Investigator Affiliation AbbVie
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Belgium, France, Israel, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Diffuse Large B-Cell Lymphoma, Chronic Lymphocytic Leukemia, B Cell Malignancies, Non-Hodgkin's Lymphoma
Arms & Interventions

Arms

Experimental: ABBV-525 Dose Escalation

Participants will receive escalating doses of ABBV-525 until doses for optimization are determined, as part of an approximately 64 month study period.

Experimental: ABBV-525 Dose Optimization

Participants will receive one of two doses of ABBV-525 until the recommended phase 2 dose (RP2D) is determined, as part of an approximately 64 month study period.

Experimental: ABBV-525 Dose Expansion

Participants will receive the RP2D dose of ABBV-525, as part of an approximately 64 month study period.

Interventions

Drug: - ABBV-525

Oral; Tablet

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Los Angeles, California

Status

Recruiting

Address

University of California Los Angeles /ID# 246357

Los Angeles, California, 90095

Site Contact

[email protected]

844-663-3742

Miami Beach, Florida

Status

Recruiting

Address

Mount Sinai Medical Center-Miami Beach /ID# 248251

Miami Beach, Florida, 33140-2948

Site Contact

[email protected]

844-663-3742

Fort Wayne, Indiana

Status

Recruiting

Address

Fort Wayne Medical Oncology and Hematology, Inc /ID# 250113

Fort Wayne, Indiana, 46804

Site Contact

[email protected]

844-663-3742

Tulane Cancer Center Clinic /ID# 249586, New Orleans, Louisiana

Status

Recruiting

Address

Tulane Cancer Center Clinic /ID# 249586

New Orleans, Louisiana, 70112

Site Contact

[email protected]

844-663-3742

START Midwest /ID# 252359, Grand Rapids, Michigan

Status

Recruiting

Address

START Midwest /ID# 252359

Grand Rapids, Michigan, 49546

Site Contact

[email protected]

844-663-3742

New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center-Koch Center /ID# 245459

New York, New York, 10065-6007

Site Contact

[email protected]

844-663-3742

Levine Cancer Institute /ID# 246363, Charlotte, North Carolina

Status

Recruiting

Address

Levine Cancer Institute /ID# 246363

Charlotte, North Carolina, 28204

Site Contact

[email protected]

844-663-3742

Houston, Texas

Status

Recruiting

Address

University of Texas MD Anderson Cancer Center /ID# 245463

Houston, Texas, 77030

Site Contact

[email protected]

844-663-3742

Tacoma, Washington

Status

Recruiting

Address

Northwest Medical Specialties - Tacoma /ID# 260376

Tacoma, Washington, 98405

Site Contact

[email protected]

844-663-3742

International Sites

Monash University /ID# 246366, Clayton, Victoria, Australia

Status

Recruiting

Address

Monash University /ID# 246366

Clayton, Victoria, 3168

Site Contact

[email protected]

844-663-3742

Alfred Health /ID# 248592, Melbourne, Victoria, Australia

Status

Recruiting

Address

Alfred Health /ID# 248592

Melbourne, Victoria, 3004

Site Contact

[email protected]

844-663-3742

UZ Gent /ID# 246462, Gent, Oost-Vlaanderen, Belgium

Status

Recruiting

Address

UZ Gent /ID# 246462

Gent, Oost-Vlaanderen, 9000

Site Contact

[email protected]

844-663-3742

Leuven, Vlaams-Brabant, Belgium

Status

Recruiting

Address

Universitair Ziekenhuis Leuven /ID# 246461

Leuven, Vlaams-Brabant, 3000

Site Contact

[email protected]

844-663-3742

Lille, Nord, France

Status

Recruiting

Address

CHRU Lille - Hopital Claude Huriez /ID# 252054

Lille, Nord, 59037

Site Contact

[email protected]

844-663-3742

IUCT Oncopole /ID# 259409, Toulouse Cedex 9, France

Status

Recruiting

Address

IUCT Oncopole /ID# 259409

Toulouse Cedex 9, , 31059

Site Contact

[email protected]

844-663-3742

Rabin Medical Center /ID# 257665, Haifa, H_efa, Israel

Status

Recruiting

Address

Rabin Medical Center /ID# 257665

Haifa, H_efa, 4941492

Site Contact

[email protected]

844-663-3742

Be'er Yaakov, HaMerkaz, Israel

Status

Recruiting

Address

Shamir Medical Center (Assaf Harofeh) /ID# 257711

Be'er Yaakov, HaMerkaz, 70300

Site Contact

[email protected]

844-663-3742

Ramat Gan, Tel-Aviv, Israel

Status

Recruiting

Address

The Chaim Sheba Medical Center /ID# 251442

Ramat Gan, Tel-Aviv, 5265601

Site Contact

[email protected]

844-663-3742

Jerusalem, Yerushalayim, Israel

Status

Recruiting

Address

Hadassah Medical Center-Hebrew University /ID# 251441

Jerusalem, Yerushalayim, 91120

Site Contact

[email protected]

844-663-3742

Hospital Clinic de Barcelona /ID# 246543, Barcelona, Spain

Status

Recruiting

Address

Hospital Clinic de Barcelona /ID# 246543

Barcelona, , 08036

Site Contact

[email protected]

844-663-3742

Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Ramon y Cajal /ID# 246540

Madrid, , 28034

Site Contact

[email protected]

844-663-3742

The Christie Hospital /ID# 250325, Manchester, United Kingdom

Status

Recruiting

Address

The Christie Hospital /ID# 250325

Manchester, , M20 4BX

Site Contact

[email protected]

844-663-3742

Resources

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with a healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with site contacts or other relevant parties. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage trial participants to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

The THANC Foundation is a 501(c)(3) charitable organization.

Federal Tax ID 80-0062118.

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THANC’s Mission

We are committed to supporting research and education in the early detection and treatment of thyroid and head and neck cancer; to advancing new therapeutic approaches; and to alleviating the suffering and functional impairment of patients who undergo treatment.

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