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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02966756
Other study ID # M14-728
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 12, 2017
Est. completion date May 30, 2029

Study information

Verified date March 2024
Source AbbVie
Contact ABBVIE CALL CENTER
Phone 844-663-3742
Email abbvieclinicaltrials@abbvie.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date May 30, 2029
Est. primary completion date May 30, 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion 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 Ă— 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. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Venetoclax
Tablet; Oral

Locations

Country Name City State
Australia Monash Medical Centre /ID# 201263 Clayton Victoria
Australia Concord Repatriation General Hospital /ID# 201261 Concord New South Wales
Australia St George Hospital /ID# 206484 Kogarah New South Wales
China Peking Union Medical College Hospital /ID# 156576 Beijing Beijing
China Peking University People's Hospital /ID# 156575 Beijing Beijing
China The First Hospital of Jilin University /ID# 156532 Changchun Jilin
China Xiangya Hospital Central South University /ID# 208913 Changsha Hunan
China The General Hospital of Western Theater Command PLA /ID# 159145 Chengdu Sichuan
China West China Hospital, Sichuan University /ID# 156537 Chengdu Sichuan
China Fujian Medical University Union Hospital /ID# 156579 Fuzhou Fujian
China Guangdong Provincial People's Hospital /ID# 160509 Guangzhou Guangdong
China Nanfang Hospital of Southern Medical University /ID# 156571 Guangzhou Guangdong
China The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 156578 Hangzhou Zhejiang
China Anhui Provincial Cancer Hospital /ID# 209458 Hefei Anhui
China Shandong Provincial Hospital /ID# 156574 Jinan Shandong
China The First Affiliated Hospital of Nanchang University /ID# 159142 Nanchang Jiangxi
China Jiangsu Province Hospital /ID# 156577 Nanjing Jiangsu
China Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 156572 Shanghai Shanghai
China The Second Hospital of Hebei Medical University /ID# 159143 Shijiazhuang Hebei
China The First Affiliated Hospital of Soochow University /ID# 156536 Suzhou Jiangsu
China Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 157762 Tianjin Tianjin
China Tianjin Medical University Cancer Institute & Hospital /ID# 156542 Tianjin Tianjin
China Tongji Hospital Tongji Medical College of HUST /ID# 156589 Wuhan Hubei
China Henan Cancer Hospital /ID# 156573 Zhengzhou Henan
New Zealand Christchurch Hospital /ID# 201650 Christchurch Canterbury
New Zealand North Shore Hospital /ID# 204637 Takapuna Auckland
Taiwan Changhua Christian Hospital /ID# 202768 Changhua City, Changhua County
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 202765 Kaohsiung
Taiwan China Medical University Hospital /ID# 202767 Taichung
Taiwan National Taiwan University Hospital /ID# 210733 Taipei City
Taiwan Linkou Chang Gung Memorial Hospital /ID# 203636 Taoyuan City

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

Australia,  China,  New Zealand,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Secondary Complete Response Rate (CRR) CRR is defined as the proportion of subjects who achieved (CR + CRi) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (iwCLL) NCI-WG criteria. Measured up to 2 years after the last participant has enrolled into the study.
Secondary Duration of Overall Response (DOR) DOR is defined as the number of days from the date of first (CR + CRi + nPR + PR) to the earliest disease progression or death Measured up to 2 years after the last participant has enrolled into the study.
Secondary Progression Free Survival (PFS) 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. Measured up to 5 years after the last participant has enrolled into the study.
Secondary Event Free Survival (EFS) 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. Measured up to 5 years after the last participant has enrolled into the study.
Secondary Time to Progression (TTP) 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). Measured up to 5 years after the last participant has enrolled into the study.
Secondary Time to 50% reduction in absolute lymphocyte count (ALC) Time to 50% reduction in ALC is defined as the number of days from the date of first dose to the date when the ALC has reduced to 50% of the baseline value. Measured up to 2 years after the last participant has enrolled into the study.
Secondary Overall Survival (OS) OS is defined as number of days from the date of first dose to the date of death. Measured up to 5 years after the last participant has enrolled into the study.
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