Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-512147-23-00 | Other Identifier | EU CT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety of venetoclax in combination with obinutuzumab or acalabrutinib in the treatment of CLL. Adverse events and change in disease activity will be assessed.
Venetoclax in combination with obinutuzumab or acalabrutinib is being investigated in the treatment of CLL. Study doctors put the participants in 1 of 4 groups, called treatment arms. Participants will receive oral venetoclax in combination with intravenously (IV) infused obinutuzumab or oral acalabrutinib at in different dosing schemes as part of treatment. Approximately 170 adult participants with CLL who are being treated with venetoclax will be enrolled in the study in approximately 80 sites worldwide.
Participants in Arm A will receive oral venetoclax in combination with IV infused obinutuzumab, with a 5 week venetoclax ramp up. Participants in Arm B will receive oral venetoclax in combination with oral acalabrutinib, with a 5 week venetoclax ramp up. Participants in Arm C and Arm D will receive oral venetoclax in combination with oral acalabrutinib, with differing venetoclax ramp up periods. The total study duration is approximately 28 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. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Venetoclax + Obinutuzumab | Experimental | Participants will receive venetoclax in combination with obinutuzumab, with a 5 week venetoclax ramp up. |
|
| Arm B: Venetoclax + Acalabrutinib | Experimental | Participants will receive venetoclax in combination with acalabrutinib, with a 5 week venetoclax ramp up. |
|
| Arm C: Venetoclax + Acalabrutinib | Experimental | Participants will receive venetoclax in combination with acalabrutinib, with a modified venetoclax ramp up A. |
|
| Arm D: Venetoclax + Acalabrutinib | Experimental | Participants will receive venetoclax in combination with acalabrutinib, with a modified venetoclax ramp up B. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax | Drug | Oral: Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Percentage of Participants with Treatment-Emergent Laboratory Tumor Lysis Syndrome (TLS)-Venetoclax | TLS is defined per Howard criteria that require a clinical intervention per independent review committee (IRC) assessment during the venetoclax ramp-up period in previously untreated participants with chronic lymphocytic leukemia (CLL) achieving a medium tumor burden with creatinine clearance (CrCl) of at least 80 ml/min or low tumor burden (regardless of CrCl level) after debulking therapy. | Up to 28 Months |
| Part 1: Percentage of Participants with Hyperkalemia-Venetoclax | Hyperkalemia (potassium >6.0 mmol/L) is defined per Howard criteria that require a clinical intervention per IRC assessment during the venetoclax ramp-up period in previously untreated participants with CLL achieving a medium tumor burden with CrCl of at least 80 ml/min or low tumor burden (regardless of CrCl level) after debulking therapy. | Up to 28 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Percentage of Participants with Treatment-Emergent Laboratory TLS | TLS is defined per Howard criteria that require a clinical intervention per IRC assessment, at each dose level and at each laboratory monitoring point during ramp-up period in previously untreated participants with CLL achieving a medium tumor burden with CrCl of at least 80 ml/min or low tumor burden (regardless of CrCl level) after debulking therapy. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Active/uncontrolled infection, no Richter's transformation, no active immune thrombocytopenia.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|---|---|---|
| Arizona Oncology - Tucson - Rudasill /ID# 267552 | Recruiting | Tucson | Arizona | 85704 | United States | |
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Acalabrutinib | Drug | Oral: Tablet |
|
| Obinutuzumab | Drug | Intravenous Infusion |
|
| Up to 28 Months |
| Part 1: Percentage of Participants with Hyperkalemia | Hyperkalemia (potassium >6.0 mmol/L) is defined per Howard criteria that require a clinical intervention per independent review committee (IRC) assessment during the venetoclax ramp-up period in previously untreated participants with CLL achieving a medium tumor burden with CrCl of at least 80 ml/min or low tumor burden (regardless of CrCl level) after debulking therapy. | Up to 28 Months |
| Part 1: Percentage of Participants with Treatment-Emergent TLS-Related Events | TLS-related events are defined as laboratory TLS per Howard criteria requiring clinical intervention per IRC assessment, hyperkalemia (potassium >6.0 mmol/L) requiring clinical intervention per IRC assessment, laboratory TLS per Howard criteria irrespective of clinical intervention, Hyperkalemia (potassium >6.0 mmol/L) irrespective of clinical intervention, clinical TLS per Howard criteria irrespective of clinical intervention, any single TLS-related lab abnormality requiring clinical intervention per Investigator. | Up to 28 Months |
| Part 1: Percentage of Participants with Adverse Events (AE) of TLS | AEs of TLS is defined as a blood chemistry changes or symptom suggestive of TLS. | Up to 28 Months |
| Part 1: Percentage of Participants with Reduction of Tumor Burden from Baseline | Percentage of participants with reduction of tumor burden. | Up to 28 Months |
| Southern VA Health Care System /ID# 266254 |
| Recruiting |
| Tucson |
| Arizona |
| 85723 |
| United States |
| UCSF FRESNO/Community Cancer Institute /ID# 270874 | Recruiting | Clovis | California | 93611 | United States |
| Valkyrie Clinical Trials /ID# 268151 | Recruiting | Los Angeles | California | 90067 | United States |
| Rocky Mountain Cancer Centers - Aurora /ID# 267549 | Recruiting | Aurora | Colorado | 80012 | United States |
| Yale University School of Medicine /ID# 266224 | Recruiting | New Haven | Connecticut | 06510 | United States |
| Malcolm Randall V.A. Medical Center /ID# 267825 | Recruiting | Gainesville | Florida | 32608 | United States |
| Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 266713 | Recruiting | Jacksonville | Florida | 32256 | United States |
| Mid Florida Hematology And Oncology Center /ID# 269159 | Recruiting | Orange City | Florida | 32763 | United States |
| Comprehensive Hematology Oncology /ID# 267644 | Recruiting | St. Petersburg | Florida | 33709 | United States |
| Springfield Clinic - First /ID# 270145 | Recruiting | Springfield | Illinois | 62702 | United States |
| Northwest Cancer Center - Dyer Clinic /ID# 268478 | Recruiting | Dyer | Indiana | 46311 | United States |
| University of Iowa Health Care /ID# 267206 | Recruiting | Des Moines | Iowa | 50314-3017 | United States |
| Willis-Knighton Medical Center /ID# 270569 | Completed | Shreveport | Louisiana | 71103 | United States |
| Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 266445 | Recruiting | Bethesda | Maryland | 20817 | United States |
| Maryland Oncology Hematology - Silver Spring /ID# 267557 | Recruiting | Silver Spring | Maryland | 20904 | United States |
| UMass Memorial Medical Center /ID# 270023 | Recruiting | Worcester | Massachusetts | 01655 | United States |
| Henry Ford Hospital /ID# 270973 | Recruiting | Detroit | Michigan | 48202 | United States |
| Saint Lukes Hospital of Kansas City /ID# 267270 | Recruiting | Kansas City | Missouri | 64111 | United States |
| Icahn School of Medicine at Mount Sinai /ID# 266328 | Recruiting | New York | New York | 10029 | United States |
| Atrium Health /ID# 267219 | Recruiting | Charlotte | North Carolina | 28204-2963 | United States |
| Atrium Health Wake Forest Baptist Medical Center /ID# 273142 | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
| Cleveland Clinic Main Campus /ID# 271292 | Recruiting | Cleveland | Ohio | 44195 | United States |
| Oklahoma Cancer Specialists and Research Institute /ID# 267643 | Recruiting | Tulsa | Oklahoma | 74146 | United States |
| Willamette Valley Cancer Institute and Research Center /ID# 266326 | Recruiting | Eugene | Oregon | 97401 | United States |
| Lifespan Cancer Institute - Providence /ID# 266550 | Recruiting | Providence | Rhode Island | 02903 | United States |
| Texas Oncology - Austin Midtown /ID# 268152 | Recruiting | Austin | Texas | 78705 | United States |
| University of Texas - Southwestern Medical Center /ID# 266528 | Recruiting | Dallas | Texas | 75235 | United States |
| Virginia Cancer Specialists - Fairfax /ID# 268155 | Recruiting | Fairfax | Virginia | 22031 | United States |
| Vista Oncology - East Olympia /ID# 267337 | Recruiting | Olympia | Washington | 98506 | United States |
|
| Northwest Medical Specialties Tacoma /ID# 266327 | Recruiting | Tacoma | Washington | 98405 | United States |
| West Virginia University School of Medicine /ID# 267645 | Recruiting | Morgantown | West Virginia | 26506 | United States |
| Calvary Mater Newcastle /ID# 267408 | Recruiting | Waratah | New South Wales | 2298 | Australia |
| Townsville University Hospital /ID# 266954 | Recruiting | Townsville | Queensland | 4814 | Australia |
| St Vincent's Hospital - Melbourne /ID# 270027 | Recruiting | Fitzroy | Victoria | 3065 | Australia |
| Royal Perth Hospital /ID# 266906 | Recruiting | Perth | Western Australia | 6000 | Australia |
| Centre Hospitalier Régional Metz Thionville - Hôpital de Mercy /ID# 266852 | Recruiting | Metz | Moselle | 57085 | France |
| Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 266270 | Recruiting | Créteil | Paris | 94010 | France |
| Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 267438 | Recruiting | Paris | Paris | 75679 | France |
| Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 266319 | Recruiting | St-Priest-en-Jarez | Pays de la Loire Region | 42270 | France |
| Centre Antoine-Lacassagne /ID# 266894 | Recruiting | Nice | Provence-Alpes-Côte d'Azur Region | 06189 | France |
| Centre Hospitalier de la Côte Basque /ID# 266847 | Recruiting | Bayonne | Pyrenees-Atlantiques | 64109 | France |
| Centre Hospitalier Métropole Savoie - Site Hôpital de Chambéry /ID# 266854 | Recruiting | Chambéry | Savoie | 73007 | France |
| CHU Amiens-Picardie Site Sud /ID# 266849 | Recruiting | Amiens | Somme | 80054 | France |
| Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 266272 | Recruiting | Orléans | 45067 | France |
| Centre Hospitalier d Argenteuil Victor Dupouy /ID# 266322 | Recruiting | Argenteuil | Île-de-France Region | 95107 | France |
| Olympion General Clinic /ID# 266819 | Recruiting | Pátrai | Achaia | 26443 | Greece |
| Evangelismos Hospital /ID# 266815 | Recruiting | Athens | Attica | 10676 | Greece |
| General Hospital of Athens Laiko /ID# 266813 | Recruiting | Athens | Attica | 11527 | Greece |
| University General Hospital Attikon /ID# 266814 | Recruiting | Athens | Attica | 12462 | Greece |
| University General Hospital of Alexandroupoli /ID# 266816 | Recruiting | Alexandroupoli | Evros | 68100 | Greece |
| Pan American Center for Oncology Trials /ID# 266243 | Recruiting | Rio Piedras | 00935 | Puerto Rico |
| Clinical Hospital Center Zvezdara /ID# 266560 | Recruiting | Belgrade | Beograd | 11000 | Serbia |
| University Clinical Center Serbia /ID# 266579 | Recruiting | Belgrade | Beograd | 11000 | Serbia |
| Clinical Hospital Center - Bežanijska Kosa /ID# 266567 | Recruiting | Belgrade | Beograd | 11080 | Serbia |
| University Clinical Center Nis /ID# 266580 | Recruiting | Niš | Nisavski Okrug | 18300 | Serbia |
| University Clinical Center Kragujevac /ID# 266568 | Recruiting | Kragujevac | Sumadijski Okrug | 34000 | Serbia |
| Institute for Oncology of Vojvodina /ID# 266556 | Recruiting | Kamenitz | Vojvodina | 21208 | Serbia |
| University Clinical Center Vojvodina /ID# 266674 | Recruiting | Novi Sad | 21000 | Serbia |
| Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 267164 | Recruiting | Santiago de Compostela | A Coruna | 15706 | Spain |
| Hospital Universitario Puerta de Hierro - Majadahonda /ID# 266967 | Recruiting | Majadahonda | Madrid | 28222 | Spain |
| Clinica Universidad de Navarra - Pamplona /ID# 267762 | Recruiting | Pamplona | Navarre | 31008 | Spain |
| CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 266969 | Recruiting | Madrid | 28027 | Spain |
| Hospital MD Anderson Cancer Center Madrid /ID# 267167 | Recruiting | Madrid | 28033 | Spain |
| Hospital Universitario Virgen del Rocio /ID# 266968 | Recruiting | Seville | 41013 | Spain |
| Kaohsiung Chang Gung Memorial Hospital /ID# 267046 | Recruiting | Kaohsiung City | Kaohsiung | 833 | Taiwan |
| China Medical University Hospital /ID# 267018 | Recruiting | Taichung | 40447 | Taiwan |
| National Taiwan University Hospital /ID# 267017 | Recruiting | Taipei | 100 | Taiwan |
| Linkou Chang Gung Memorial Hospital /ID# 267045 | Recruiting | Taoyuan City | 333 | Taiwan |
| Nottingham City Hospital /ID# 266991 | Recruiting | Nottingham | Nottinghamshire | NG5 1PB | United Kingdom |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C579720 | venetoclax |
| C000604908 | acalabrutinib |
| C543332 | obinutuzumab |
Not provided
Not provided
Not provided