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Efficacy and Safety of BGB-3111 in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03206918
Recruitment Status : Active, not recruiting
First Posted : July 2, 2017
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
BeiGene

Brief Summary:
This is a single-arm, open-label, multi-center Phase 2 study in subjects with histologically documented CLL/SLL who have relapsed after ≥ 1 prior treatment regimen(s). The study is composed of an initial screening phase, a single-arm treatment phase, and a follow-up phase.

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Chronic Lymphocytic Leukemia Relapsed or Refractory Small Lymphocytic Lymphoma Drug: BGB-3111 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate Safety and Efficacy of BGB-3111, a Bruton's Tyrosine Kinase (BTK) Inhibitor in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: BGB-3111 Drug: BGB-3111
BGB-3111 160 mg (two - 80 mg white opaque capsules) PO BID




Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Up to 3 years ]
  2. Duration of response (DOR) [ Time Frame: Up to 3 years ]
  3. Time to response (TTR) [ Time Frame: Up to 3 years ]
  4. The safety and tolerability of BGB-3111, measured by the incidence, timing, and severity of AEs [ Time Frame: Up to 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Confirmed diagnosis of CLL/SLL.
  2. Meeting at least one criterion for treatment according to IWCLL.
  3. Men and women >18 years of age.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  5. Measurable disease by contrast enhanced computerized tomography/magnetic resonance imaging (CT/MRI).
  6. Received at least one prior therapy for CLL/SLL.
  7. Documented failure to achieve at least partial response (PR) or documented disease progression after response to, the most recent treatment regimen.
  8. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN.
  9. Bilirubin ≤ 2 x ULN (unless documented Gilbert's syndrome).
  10. International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN.
  11. Females of childbearing potential must agree to use highly effective forms of birth control throughout the course of the study and at least up to 90 days after last dose of study drug.
  12. Able to provide written informed consent, can understand and comply with the requirements of the study

Exclusion Criteria:

  1. Prior exposure to a BTK inhibitor.
  2. Prior corticosteroids given with anti-neoplastic intent within 7 days.
  3. Major surgery within 4 weeks of screening.
  4. Not recovered from toxicity of any prior anti-cancer therapy.
  5. History of other active malignancies within 2 years of study entry
  6. Currently active clinically significant cardiovascular disease
  7. Pregnant or lactating women.
  8. History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug.
  9. Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, or put the study at risk.

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): NCT03206918


Locations
China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China
Peking University People's Hospital
Beijing, Beijing, China
China, Fujian
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China
Nanfang Hospital
Guangzhou, Guangdong, China
China, Guangxi
The First Affiliated Hospital of GuangXi Medical University
Nanning, Guangxi, China
China, Henan
Henan Cancer Province
Zhengzhou, Henan, China
China, Hubei
Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
China, Jiangsu
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
China, Jinlin
The First Affilliated Hospital of Jinlin University
Changchun, Jinlin, China
China, Shanghai
Rui Jin Hospital Shanghai Jiao Tong University Schlool of Medicine
Shanghai, Shanghai, China
China, Shanxi
The 1st Affiliated Hospital of Xi'An Jiaotong University
Xi'an, Shanxi, China
China, Sichuan
West China Hospital of Sichuan University
Chengdu, Sichuan, China
China, Tianjin
Tianjin Hematonosis Hospital
Tianjin, Tianjin, China
China, Zhejiang
The First affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Sponsors and Collaborators
BeiGene

Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03206918     History of Changes
Other Study ID Numbers: BGB-3111-205
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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