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Clinical Trials List

Protocol NumberM14-728
NCT Number(ClinicalTrials.gov Identfier)NCT02966756
Active

2018-06-26 - 2030-12-31

Phase II

Recruiting6

ICD-10C91.10

Chronic lymphocytic leukemia of B-cell type not having achieved remission

A Phase 2 Open-Label Study of the Efficacy of Venetoclax in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia in the Presence of 17p Deletion

  • Trial Applicant

    AbbVie

  • Sponsor

    ABBVIE BIOPHARMACEUTICALS GMBH TAIWAN BRANCH (SWITZERLAND

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/21

Investigators and Locations

Principal Investigator Yi-Chang Liu Division of Hematology & Oncology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Su-Peng Yeh Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張正雄 Division of Hematology & Oncology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shang-Ju Wu Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator Su-Peng Yeh 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator
Kaohsiung Municipal Ta-Tung Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Chung Kao
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Condition/Disease

Chronic Lymphocytic Leukemia (CLL) Small Lymphocytic Lymphoma (SLL)

Objectives

This is a Phase 2, open-label, multicenter study, evaluating the efficacy of venetoclax in participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) either in presence of 17p deletion (Cohort 1) or those who have failed a B-receptor signaling pathway inhibitor (BCRI) therapy and who have also failed, or were unable to receive chemoimmunotherapy (CIT) irrespective of 17p status (Cohort 2).

Test Drug

Venetoclax

Active Ingredient

Venetoclax

Dosage Form

N/A

Dosage

N/A

Endpoints

Overall Response Rate (ORR) 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). Measured up to 2 years after the last participant has enrolled in the study.

Inclution Criteria

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.
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, or participants in whom the investigator evaluated that the use of CIT was inappropriate.
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 or other BCL-2 inhibitors.
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.
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.

The Estimated Number of Participants

  • Taiwan

    10 participants

  • Global

    110 participants

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