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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504599-10-00 | Other Identifier | EU CT |
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| Name | Class |
|---|---|
| F. Hoffmann-La Roche Ltd; German CLL Study Group (GCLLSG); Dana-Farber Cancer Institute | UNKNOWN |
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Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess retreatment with venetoclax-obinutuzumab (VenG) in participants previously treated with fixed duration first-line (IL) therapy of venetoclax in combination with an anti-CD20 antibody +/- X (where X is any additional drug). Adverse events and change in disease activity will be assessed.
Venetoclax is an approved drug for the treatment of CLL. Study doctors put the participants in 1 of 2 groups, called cohorts, based on when symptoms of CLL came back after previous treatment in first-line. Approximately 75 adult participants with CLL who have been treated with venetoclax in combination with an anti-CD20 antibody +/- X will be enrolled in the study in approximately 60 sites worldwide.
Participants will receive intravenous (IV) obinutuzumab + oral venetoclax (VenG) in 28-day cycles for a total of 6 cycles per cohort, followed by 6 to 18 cycles of venetoclax alone, for a total treatment of 12 to 24 cycles, depending on the cohort.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - venetoclax + obinutuzumab | Experimental | Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for six 28-day cycles. |
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| Cohort 2 - venetoclax + obinutuzumab | Experimental | Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for eighteen 28-day cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax | Drug | Oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response (OR) in Cohort 1 after end of combination treatment | OR is defined as the percentage of participants achieving a best response of partial remission (PR), nodular partial remission (nPR), complete remission with incomplete marrow recovery (CRi), or complete remission (CR). Disease assessments will be based on the 2018 International Workshop for Chronic Lymphocytic Leukemia (iwCLL) criteria for tumor response. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| OR in Cohort 1 after end of combination treatment | OR rate is defined as the percentage of participants achieving a best response of CR or CRi | 9 months |
| OR in Cohort 1 after end of treatment | OR is defined as the percentage of participants achieving a best response of PR, nPR, CRi, or CR. Disease assessments will be based on the 2018 iwCLL criteria for tumor response. |
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Inclusion Criteria:
Exclusion Criteria:
- Received intervening treatment for CLL after completing previous treatment with a venetoclax + anti-CD20 antibody +/- X regimen.
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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 |
|---|---|---|---|---|---|---|
| Moores Cancer Center at UC San Diego /ID# 230157 | Recruiting | La Jolla | California | 92093 | United States | |
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| Label | URL |
|---|---|
| Related info | View source |
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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/
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| Obinutuzumab | Drug | Intravenous (IV) infusion |
|
|
| 15 months |
| Time to Response (TTR) in Cohort 1 | TTR is defined as the time from first dose until first response (PR or better). | 15 months |
| Duration of Response (DOR) in Cohort 1 | DOR is defined as the time from first response (PR or better) until progressive disease (PD) or death. | 15 months |
| Time to Next Treatment (TTNT) for CLL in Cohort 1 | TTNT is defined as the time from first dose until first dose of a non-protocol anti-CLL therapy. | 15 months |
| Progression-free Survival (PFS) in Cohort 1 | PFS is defined as the time from first dose until PD or death. | 15 months |
| Overall Survival (OS) in Cohort 1 | OS is defined as the time from first dose until death. | 15 months |
| Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of combination treatment | Percentage of participants with uMRD rate, measured in peripheral blood. | 9 months |
| Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of treatment | Percentage of participants with uMRD rate, measured in peripheral blood. | 15 months |
| Winship Cancer Institute of Emory University /ID# 230643 |
| Recruiting |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Des Moines Oncology Research Association /ID# 232606 | Completed | Des Moines | Iowa | 50309-1423 | United States |
| Dana-Farber Cancer Institute /ID# 230061 | Recruiting | Boston | Massachusetts | 02215 | United States |
| Henry Ford Hospital /ID# 230268 | Completed | Detroit | Michigan | 48202 | United States |
| St. Lukes Hospital of Duluth /ID# 250021 | Recruiting | Duluth | Minnesota | 55805 | United States |
| Hattiesburg Clinic /ID# 233443 | Recruiting | Hattiesburg | Mississippi | 39401 | United States |
| Summit Medical Group-Florham Park /ID# 244782 | Completed | Florham Park | New Jersey | 07932-1049 | United States |
| Regional Cancer Care Associates /ID# 244620 | Recruiting | Hackensack | New Jersey | 07601-7015 | United States |
| University of North Carolina /ID# 233313 | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
| Novant Health Presbyterian Medical Center /ID# 230201 | Recruiting | Charlotte | North Carolina | 28204 | United States |
| Novant Health Forsyth Medical Center /ID# 249533 | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
| The Ohio State University /ID# 230439 | Recruiting | Columbus | Ohio | 43210 | United States |
| Pennsylvania Oncology Hematolo /ID# 249637 | Recruiting | Philadelphia | Pennsylvania | 19106 | United States |
| University of Wisconsin-Madiso /ID# 232612 | Completed | Madison | Wisconsin | 53705 | United States |
| Royal Adelaide Hospital /ID# 229898 | Recruiting | Adelaide | South Australia | 5000 | Australia |
| Northern Hospital Epping /ID# 229847 | Recruiting | Epping | Victoria | 3076 | Australia |
| Peter MacCallum Cancer Ctr /ID# 254634 | Recruiting | Melbourne | Victoria | 3000 | Australia |
| Universitaetsklinikum St. Poelten /ID# 243493 | Recruiting | Sankt Pölten | Lower Austria | 3100 | Austria |
| Medizinische Universitaet Wien /ID# 230013 | Recruiting | Vienna | State of Vienna | 1090 | Austria |
| Klinik Ottakring /ID# 230019 | Recruiting | Vienna | State of Vienna | 1160 | Austria |
| Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 267569 | Recruiting | Leoben | Styria | 8700 | Austria |
| Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 249516 | Recruiting | Linz | Upper Austria | 4010 | Austria |
| Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 230015 | Completed | Salzburg | 5020 | Austria |
| Hanusch Krankenhaus /ID# 230010 | Recruiting | Vienna | 1140 | Austria |
| Hospital de Clinicas de Porto Alegre /ID# 243657 | Completed | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Hospital Nove de Julho /ID# 243658 | Recruiting | São Paulo | São Paulo | 01409-001 | Brazil |
| Instituto de Ensino e Pesquisas Sao Lucas /ID# 243659 | Recruiting | São Paulo | 01236-030 | Brazil |
| UMHAT Sveti Georgi EAD /ID# 272321 | Recruiting | Plovdiv | 4002 | Bulgaria |
| MHAT Hristo Botev /ID# 229687 | Recruiting | Vratsa | 3000 | Bulgaria |
| Stauferklinikum Schwaebisch Gmuend /ID# 230176 | Recruiting | Mutlangen | Baden-Wurttemberg | 73557 | Germany |
| Universitaetsklinikum Ulm /ID# 230164 | Recruiting | Ulm | Baden-Wurttemberg | 89081 | Germany |
| VK&K Studien GbR /ID# 230198 | Recruiting | Landshut | Bavaria | 84036 | Germany |
| Muenchen Klinik Schwabing /ID# 230197 | Completed | Munich | Bavaria | 80804 | Germany |
| Universitaetsmedizin Rostock /ID# 230190 | Recruiting | Rostock | Mecklenburg-Vorpommern | 18057 | Germany |
| Universitaetsklinikum Koeln /ID# 230296 | Recruiting | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Universitaetsklinikum des Saarlandes /ID# 248747 | Recruiting | Homburg | Saarland | 66424 | Germany |
| BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 230168 | Recruiting | Dresden | Saxony | 01307 | Germany |
| Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 230186 | Recruiting | Kiel | Schleswig-Holstein | 24105 | Germany |
| Onkologische Schwerpunktpraxis /ID# 245465 | Recruiting | Berlin | 10707 | Germany |
| Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 248748 | Recruiting | Berlin | 13353 | Germany |
| Duplicate_DIAKO Ev. Diakonie-Krankenhaus gemeinnuetzige GmbH /ID# 230238 | Completed | Bremen | 28239 | Germany |
| Universitaetsklinikum Essen /ID# 230181 | Recruiting | Essen | 45147 | Germany |
| Universitaetsklinikum Halle (Saale) /ID# 245350 | Recruiting | Halle | 06120 | Germany |
| OncoResearch Lerchenfeld GmbH /ID# 230191 | Recruiting | Hamburg | 22081 | Germany |
| Klinikum Landshut AdöR der Stadt Landshut /ID# 242991 | Recruiting | Landshut | 84034 | Germany |
| Bruederkrankenhaus St. Josef Paderborn /ID# 230177 | Recruiting | Paderborn | 33098 | Germany |
| Hadassah /ID# 245059 | Recruiting | Jerusalem | Jerusalem | 91120 | Israel |
| The Chaim Sheba Medical Center /ID# 243219 | Recruiting | Ramat Gan | Tel Aviv | 5265601 | Israel |
| Tel Aviv Sourasky Medical Center /ID# 243218 | Recruiting | Tel Aviv | Tel Aviv | 6423906 | Israel |
| Rabin Medical Center. /ID# 243220 | Recruiting | Petah Tikva | 4941492 | Israel |
| A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 229504 | Recruiting | Turin | Piedmont | 10126 | Italy |
| Azienda Ospedaliera Santa Maria Terni /ID# 229442 | Recruiting | Terni | 05100 | Italy |
| Fundeni Clinical Institute /ID# 241614 | Recruiting | Bucharest | Bucharest | 022328 | Romania |
| Hospital Universitario de la Princesa /ID# 229665 | Recruiting | Madrid | 28006 | Spain |
| Blackpool Victoria Hospital /ID# 267280 | Recruiting | Blackpool | Lancashire | FY3 8NR | United Kingdom |
| Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 250733 | Recruiting | Norwich | Norfolk | NR4 7UY | United Kingdom |
| Leeds Teaching Hospitals NHS Trust /ID# 250732 | Recruiting | Leeds | West Yorkshire | LS9 7TF | United Kingdom |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| 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 |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
| C543332 | obinutuzumab |
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