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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 : July 19, 2019
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

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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 9, 2017
Actual Primary Completion Date : June 15, 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 ]


Information from the National Library of Medicine

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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. Previously treated with a minimum of 1 prior line of standard chemotherapy-containing regimen (with completion of ≥2 treatment cycles).

7. Documented failure to achieve at least partial response (PR) or documented disease progression after response to the most recent treatment regimen. Refractory disease is defined as treatment failure (stable disease, non-response, progressive disease [PD]) or disease progression within 6 months after the most recent prior therapy (Hallek et al, 2008).

8. Neutrophils ≥ 0.75 x 109/L independent of growth factor support within 7 days of study entry 9. Platelets ≥ 50 x 109/L, independent of growth factor support or transfusion within 7 days of study entry 10. Creatinine clearance of ≥ 30 ml/min (as estimated by the Cockcroft-Gault equation or estimated glomerular filtration rate [eGFR] from the Modification of Diet in Renal Disease [MDRD]) 11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 x ULN 12. Bilirubin ≤2 x ULN (unless documented Gilbert's syndrome) 13. International normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5 x ULN.

14. Subjects may be enrolled who relapse after autologous stem cell transplant if they are at least 6 months after transplant.

15. 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. Highly effective forms of birth control can be defined as abstinence, hysterectomy, bilateral oophorectomy with no menstrual bleeding for up to 6 months, intrauterine contraception, hormonal methods such as contraceptive injection, oral contraceptive, etc. Males must have undergone sterilization-vasectomy, or utilize a barrier method where the female partner utilizes the effective forms of birth control noted above.

16. Life expectancy of >4 months 17. Able to provide written informed consent, can understand and comply with the requirements of the study 18. Echocardiogram (ECHO) must demonstrate left ventricular ejection fraction (LVEF) ≥50%; (AHA, 2016)

Exclusion Criteria:

  1. Current or history of central nervous system (CNS) lymphoma
  2. Prior exposure to a BTK inhibitor
  3. Prior corticosteroids given in excess of prednisone 10 mg/day or its equivalent with antineoplastic intent within 7 days.
  4. Major surgery within 4 weeks of screening
  5. Not recovered from toxicity of any prior anti-cancer therapy to <Grade 1 (except for alopecia, absolute neutrophil count (ANC) and platelets.
  6. History of other active malignancies within 2 years of study entry, with exception of (1) adequately treated in-situ carcinoma of cervix; (2) localized basal cell or squamous cell carcinoma of skin; (3) previous malignancy confined and treated locally (surgery or other modality) with curative intent
  7. Currently active clinically significant cardiovascular disease
  8. QTcF >480 msecs based on Fridericia's formula or other significant electrocardiogram abnormalities including second degree atrioventricular (AV) block Type II, or third degree AV block
  9. Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction
  10. Active infection including infections requiring oral or intravenous anti-microbials
  11. Known human immunodeficiency virus (HIV), or active hepatitis B or hepatitis C infection (detected positive by polymerase chain reaction [PCR]).
  12. Pregnant or lactating women
  13. 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
  14. Requires ongoing treatment with any medication which is a strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitor or strong CYP3A inducer
  15. Known or clinically suspected Richter's transformation at the time of study entry
  16. History of stroke or intracranial hemorrhage within 6 months prior to enrollment
  17. Has received allogenic hematopoietic stem cell transplantation prior to enrollment

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
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China, Beijing
Peking University People's Hospital
Beijing, Beijing, China, 100082
Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
China, Fujian
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
Nanfang Hospital
Guangzhou, Guangdong, China, 510515
China, Henan
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
China, Hubei
Tongji Hospital of Tongji Medical College of HUST
Wuhan, Hubei, China, 430030
China, Jiangsu
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
China, Jinlin
The First Affilliated Hospital of Jinlin University
Changchun, Jinlin, China, 130021
China, Shanghai
Shanghai Ruijin Hospital
Shanghai, Shanghai, China, 200025
China, Sichuan
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
China, Tianjin
Tianjin Hematonosis Hospital
Tianjin, Tianjin, China, 300020
Sponsors and Collaborators
BeiGene

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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03206918     History of Changes
Other Study ID Numbers: BGB-3111-205
CTR20160890 ( Registry Identifier: Center for drug evaluation, CFDA )
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: May 2019

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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

Additional relevant MeSH terms:
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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
Zanubrutinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action