A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy
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| ClinicalTrials.gov Identifier: NCT03406156 |
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Recruitment Status :
Recruiting
First Posted : January 23, 2018
Last Update Posted : July 29, 2019
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Sponsor:
AbbVie
Information provided by (Responsible Party):
AbbVie
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Brief Summary:
A study in previously untreated Chronic Lymphocytic Leukemia to evaluate alternate administration strategies for induction therapy (debulking) with obinutuzumab or obinutuzumab/bendamustine prior to combination therapy with obinutuzumab and venetoclax.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Lymphocytic Leukemia (CLL) Small Lymphocytic Lymphoma (SLL) | Drug: Obinutuzumab Drug: Bendamustine Drug: Venetoclax | Phase 3 |
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3b Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy |
| Actual Study Start Date : | August 10, 2018 |
| Estimated Primary Completion Date : | April 3, 2022 |
| Estimated Study Completion Date : | July 16, 2024 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Obinutuzumab +/- bendamustine then obinutuzumab + venetoclax
Debulking Period: Obinutuzumab with or without bendamustine (bendamustine administered in participants with high tumor load as described in the protocol) during the debulking period (up to 6 cycles). Treatment Period: Venetoclax + obinutuzumab regimen initiated when participant achieves low tumor burden during debulking period, or if the participant has not achieved low tumor burden status after 6 cycles of debulking, the participant may proceed to venetoclax per the discretion of the treating provider after discussion with the study physician. During this regimen period, participants to receive obinutuzumab in combination with venetoclax for 5 months then venetoclax therapy alone to continue for a total duration of 52 weeks. |
Drug: Obinutuzumab
intravenous
Other Name: Gazyva Drug: Bendamustine intravenous
Other Name: Bendeka Drug: Venetoclax tablet
Other Names:
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Primary Outcome Measures :
- Percent of Participants Achieving Low Tumor Burden Status with induction of Obinutuzumab or Obinutuzumab plus Bendamustine (Debulking Period) [ Time Frame: Up to approximately 24 weeks after initial dose of study drug ]Low tumor burden is defined by peripheral lymphocyte counts of < 25,000 and all lymph nodes < 5 cm per CT scans.
- Complete Remission Rate (CR) and Complete Remission with Incomplete Marrow Recovery (CRi) [ Time Frame: Up to approximately 65 weeks after initial dose of venetoclax ]Defined as the proportion of subjects who achieved CR or CRi (per the 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-sponsored Working Group [IWCLL NCI-WG] criteria).
Secondary Outcome Measures :
- Overall Response Rate (ORR) [ Time Frame: Up to approximately 3.5 years after initial dose of study drug ]ORR is defined as the proportion of participants with an overall response (CR, CRi, nodular partial remission [nPR] plus partial remission [PR]) per the 2008 Modified IWCLL NCI-WG criteria.
- Duration of Response (DoR) [ Time Frame: Up to approximately 3.5 years after initial dose of study drug ]DOR defined as the number of days from the date of first response (CR, CRi, nPR, or PR) (per the 2008 Modified IWCLL NCI-WG criteria) to the date of disease progression or death. All disease progression will be included regardless whether the event occurred during or after the participant was taking any study drug (either venetoclax, obinutuzumab, or bendamustine).
- Progression-Free Survival (PFS) [ Time Frame: Up to approximately 3.5 years after initial dose of study drug ]PFS is defined as the number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to the date of disease progression or death, whichever occurs first. All disease progression will be included regardless whether the event occurred during or after the participant was taking any study drug.
- Time to Progression (TTP) [ Time Frame: Up to approximately 3.5 years after initial dose of study drug ]TPP is defined as the number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to date of disease progression. All disease progression will be included regardless whether the event occurred during or after the participant was taking any study drug.
- Overall Survival (OS) [ Time Frame: Up to approximately 3.5 years after initial dose of study drug ]OS is defined as number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to the date of death.
- Minimal Residual Disease (MRD) Negativity Rate [ Time Frame: Up to approximately 3.5 years after initial dose of study drug ]MRD negativity defined as less than one CLL cell per 10,000 leukocytes (or below 10^-4). Rate of MRD status will be defined as the proportion of participants who have MRD negativity status.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adequate hematology, kidney and liver function as described in the protocol.
- Diagnosis of previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) according to 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-sponsored Working Group (IWCLL NCI-WG) criteria.
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 - 1.
- CLL requires treatment according to the IWCLL criteria.
- Medium tumor burden (any lymph node [LN] 5 to < 10 cm OR absolute lymphocyte count [ALC] >= 25 × 10^9/L) OR High tumor burden (any LN >= 10 cm OR ALC >= 25 × 10^9/L and LN >= 5 cm).
Exclusion Criteria:
- Presence of 17p deletion at Screening.
- Richter's syndrome (transformation of CLL/SLL to aggressive non-Hodgkin's lymphoma or Hodgkin's lymphoma).
- Prolymphocytic leukemia.
Information from the National Library of Medicine
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): NCT03406156
Contacts
| Contact: ABBVIE CALL CENTER | 847.283.8955 | abbvieclinicaltrials@abbvie.com |
Locations
| United States, Arizona | |
| Arizona Oncology Associates, PC-HOPE /ID# 202335 | Recruiting |
| Tucson, Arizona, United States, 85711-2701 | |
| United States, Colorado | |
| Rocky Mountain Cancer Centers - Denver Midtown /ID# 202328 | Recruiting |
| Denver, Colorado, United States, 80218 | |
| United States, Missouri | |
| MidAmerica Division, Inc. /ID# 201099 | Recruiting |
| Kansas City, Missouri, United States, 64132 | |
| United States, Ohio | |
| Oncology Hematology Care, Inc - Kenwood /ID# 202397 | Recruiting |
| Cincinnati, Ohio, United States, 45236-2725 | |
| United States, Oregon | |
| Willamette Valley Cancer Institute /ID# 201201 | Recruiting |
| Eugene, Oregon, United States, 97401-6043 | |
| United States, South Carolina | |
| Greenville Health System - Int'l Dr /ID# 202329 | Recruiting |
| Greenville, South Carolina, United States, 29615 | |
| United States, Tennessee | |
| Tennessee Oncology - Chattanooga /ID# 202840 | Recruiting |
| Chattanooga, Tennessee, United States, 37404-1108 | |
| Tennessee Oncology-Nashville Centennial /ID# 201098 | Recruiting |
| Nashville, Tennessee, United States, 37203-1632 | |
| United States, Texas | |
| Texas Oncology - Austin Midtown /ID# 201199 | Recruiting |
| Austin, Texas, United States, 78705 | |
| Texas Oncology - Beaumont /ID# 202359 | Recruiting |
| Beaumont, Texas, United States, 77701-4691 | |
| Texas Oncology - Dallas /ID# 201196 | Recruiting |
| Dallas, Texas, United States, 75230 | |
| Texas Oncology - McAllen /ID# 202331 | Recruiting |
| McAllen, Texas, United States, 78503 | |
| Texas Oncology - San Antonio Medical Center /ID# 202332 | Recruiting |
| San Antonio, Texas, United States, 78240-5251 | |
| Texas Oncology - Tyler /ID# 201211 | Recruiting |
| Tyler, Texas, United States, 75702 | |
| United States, Washington | |
| Northwest Cancer Specialists, P.C. /ID# 201198 | Recruiting |
| Vancouver, Washington, United States, 98684 | |
Sponsors and Collaborators
AbbVie
Investigators
| Study Director: | AbbVie Inc. | AbbVie |
Additional Information:
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT03406156 History of Changes |
| Other Study ID Numbers: |
M16-788 |
| First Posted: | January 23, 2018 Key Record Dates |
| Last Update Posted: | July 29, 2019 |
| Last Verified: | July 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) Analytic Code |
| Time Frame: | Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. |
| Access Criteria: | Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. |
| URL: | https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html |
| 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 |
Keywords provided by AbbVie:
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Cancer Chronic Lymphocytic Leukemia 17p Deletion debulking obinutuzumab |
bendamustine tumor lysis syndrome venetoclax Small Lymphocytic Lymphoma |
Additional relevant MeSH terms:
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Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Leukemia, B-Cell Bendamustine Hydrochloride Venetoclax Obinutuzumab Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antineoplastic Agents, Immunological |