A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
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ClinicalTrials.gov Identifier: NCT02966756 |
Recruitment Status :
Recruiting
First Posted : November 17, 2016
Last Update Posted : July 7, 2022
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Condition or disease | Intervention/treatment | Phase |
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Chronic Lymphocytic Leukemia (CLL) Small Lymphocytic Lymphoma (SLL) | Drug: Venetoclax | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 110 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Open-Label Study of the Efficacy of Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
Actual Study Start Date : | October 12, 2017 |
Estimated Primary Completion Date : | May 31, 2026 |
Estimated Study Completion Date : | May 30, 2029 |

Arm | Intervention/treatment |
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Experimental: Cohort 1: Venetoclax
Participants with 17p deletion status will receive various doses of venetoclax once daily (QD).
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Drug: Venetoclax
Tablet; Oral
Other Names:
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Experimental: Cohort 2: Venetoclax
Participants who have failed a B-Cell Receptor Signaling Pathway Inhibitor (BCRI) therapy and who have also failed, or were unable to receive chemoimmunotherapy (CIT) irrespective of 17p status will receive various doses of venetoclax once daily (QD).
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Drug: Venetoclax
Tablet; Oral
Other Names:
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- Overall Response Rate (ORR) [ Time Frame: Measured up to 2 years after the last participant has enrolled in the study. ]ORR is the proportion of participants with an overall response (complete remission [CR], plus complete remission with incomplete bone marrow recovery [CRi], plus nodular partial remission [nPR], plus partial remission [PR]) per the National Cancer Institute-Working Group (NCI-WG) guidelines as assessed by the Independent Review Committee (IRC).
- Complete Response Rate (CRR) [ Time Frame: Measured up to 2 years after the last participant has enrolled into the study. ]CRR is defined as the proportion of subjects who achieved (CR + CRi) per the 2008 Modified iwCLL NCI-WG criteria.
- Duration of Overall Response (DOR) [ Time Frame: Measured up to 2 years after the last participant has enrolled into the study. ]DOR is defined as the number of days from the date of first (CR + CRi + nPR + PR) to the earliest disease progression or death
- Progression Free Survival (PFS) [ Time Frame: Measured up to 5 years after the last participant has enrolled into the study. ]PFS is defined as the number of days from the date of first dose to the date of earliest disease progression (determined by the IRC) or death.
- Event Free Survival (EFS) [ Time Frame: Measured up to 5 years after the last participant has enrolled into the study. ]EFS is defined as the number of days from the date of first dose to the date of earliest disease progression, death, or start of a new anti-leukemic therapy.
- Time to Progression (TTP) [ Time Frame: Measured up to 5 years after the last participant has enrolled into the study. ]TTP is defined as the number of days from the date of first dose to the date of earliest disease progression (determined by the IRC).
- Time to 50% reduction in absolute lymphocyte count (ALC) [ Time Frame: Measured up to 2 years after the last participant has enrolled into the study. ]Time to 50% reduction in ALC is defined as the number of days (hours if applicable) from the date of first dose to the date when the ALC has reduced to 50% of the baseline value
- Overall Survival (OS) [ Time Frame: Measured up to 5 years after the last participant has enrolled into the study. ]OS is defined as number of days from the date of first dose to the date of death.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Participant must have a diagnosis of relapsed or refractory chronic lymphocytic leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) that meets 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (iwCLL) National Cancer Institute-Working Group (NCI-WG) Guidelines and the following:
- Participant must have an indication for treatment according to the 2008 Modified iwCLL NCI-WG Guidelines.
- SLL participant must have measurable disease (B-lymphocytosis greater than 5 × 10^9/L or an enlarged lymph node(s) (Longest Diameter (LDi) > 1.5 cm at baseline) or hepatomegaly or splenomegaly due to CLL).
- SLL participant must have presence of lymphadenopathy and absence of cytopenias caused by a clonal marrow infiltrate.
- Participant must have relapsed or refractory CLL/SLL after receiving at least one prior line of therapy.
- Participants (in Cohort 1) must have 17p deletion, assessed by a central laboratory.
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Participants (in Cohort 2) must meet both of the following:
- Relapsed/refractory disease to B-Cell Receptor Signaling Pathway Inhibitor (BCRI) treatment;
- And either of the following: (a) relapsed/refractory disease to chemoimmunotherapy (CIT), or (b) ineligible to receive CIT, defined as having known 17p deletion or TP53 mutation, or Cumulative Illness Rating Scale (CIRS) >6 or calculated creatinine clearance <70 mL/min.
- Participant must have an Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.
- Participant must have adequate bone marrow function, coagulation profile, renal, and hepatic function, per laboratory reference range at Screening.
- No known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
Exclusion Criteria:
- Participant has undergone an allogeneic stem cell transplant.
- Participant has developed Richter's transformation confirmed by biopsy.
- Participant has prolymphocytic leukemia.
- Participant has active and uncontrolled autoimmune cytopenias (for 2 weeks prior to screening), including autoimmune hemolytic anemia (AIHA) and idiopathic thrombocytopenic purpura (ITP).
- Participant has previously received venetoclax.
- Participant is known to be positive for Human Immunodeficiency Virus (HIV).
- Participant has received a biologic agent for anti-neoplastic intent within 30 days prior to the first dose of study drug.
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Participant has received any of the following within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of venetoclax, or has not recovered to less than Common Toxicity Criteria for Adverse Events (CTCAE) grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy:
- Any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy or targeted small molecule agents.
- Investigational therapy, including targeted small molecule agents.
- Participant has known allergy to both xanthine oxidase inhibitors and rasburicase.

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): NCT02966756
Contact: ABBVIE CALL CENTER | 844-663-3742 | abbvieclinicaltrials@abbvie.com |

Study Director: | ABBVIE INC. | AbbVie |
Responsible Party: | AbbVie |
ClinicalTrials.gov Identifier: | NCT02966756 |
Other Study ID Numbers: |
M14-728 |
First Posted: | November 17, 2016 Key Record Dates |
Last Update Posted: | July 7, 2022 |
Last Verified: | July 2022 |
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, analyses plans, 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) |
Time Frame: | For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/ |
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ |
URL: | https://vivli.org/ourmember/abbvie/ |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Relapsed chronic lymphocytic leukemia (CLL) Refractory chronic lymphocytic leukemia (CLL) 17p deletion Venetoclax |
Leukemia Lymphoproliferative Disorders Small Lymphocytic Lymphoma (SLL) Venclexta |
Lymphoma 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 Venetoclax Antineoplastic Agents |