Efficacy and Safety of Ibrutinib in Patients With CLL and Other Indolent B-cell Lymphomas Who Are Chronic Hepatitis B Virus Carriers or Occult Hepatitis B Virus Carriers
1 other identifier
interventional
62
1 country
1
Brief Summary
Efficacy and Safety of ibrutinib in patients with chronic lymphocytic leukemia and other indolent B-cell lymphomas who are chronic hepatitis B virus carriers or occult hepatitis B virus carriers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2016
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 2, 2016
CompletedFirst Posted
Study publicly available on registry
December 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedApril 12, 2018
April 1, 2018
4.1 years
December 2, 2016
April 11, 2018
Conditions
Outcome Measures
Primary Outcomes (4)
Overall response rate (ORR)
proportion of patients achieving CR or partial remission (PR)
2 years
Duration of remission
two year
Rates of HBV Reactivation while on Ibrutinib therapy
two year
Adverse events and severe adverse events
Incidence of AE and SAE by severity grading as assessed according to CTCAE v4.03
two year
Study Arms (1)
Ibrutinib
OTHERRelapsed / refractory chronic lymphocytic leukemia and Waldenstrom macroglobulinaemia (lymphoplasmacytic lymphoma): 420 mg daily Relapsed / refractory mantle cell lymphoma: 560 mg daily Relapsed / refractory indolent B-cell non-Hodgkin lymphoma: 560 mg daily Treatment is continued until disease progression
Interventions
Relapsed / refractory chronic lymphocytic leukemia and Waldenstrom macroglobulinaemia (lymphoplasmacytic lymphoma): 420 mg daily Relapsed / refractory mantle cell lymphoma: 560 mg daily Relapsed / refractory indolent B-cell non-Hodgkin lymphoma: 560 mg daily Treatment is continued until disease progression
Eligibility Criteria
You may qualify if:
- Adult patients between age of 18 - 80 years
- Patients with indolent B-cell lymphoproliferative neoplasms that have relapsed or are refractory after at least one standard line of therapy that contains rituximab
- Pathologically proven B-cell lymphoproliferative neoplasms including chronic lymphocytic leukaemia/small lymphocytic lymphoma, mantle cell lymphoma, marginal-zone B-cell lymphoma, and Waldenstrom macroglobulinaemia (lymphoplasmacytic lymphoma).
- Pathologically proven follicular lymphoma, with relapse or disease progression \> 12 months after previous rituximab therapy.
- Chronic HBV carriers (HBsAg+)
- Occult HBV carriers (HBsAg-, anti-HBc+ and HBV DNA-)
- Haematology values within the following limits:
- Absolute neutrophil count (ANC)1000/mm3 independent of growth factor support
- Platelets 100,000/mm3, or 50,000/mm3 if bone marrow is involved, and independent of transfusion support in either situation
- Biochemical values within the following limits:
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 x upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 x ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
- Serum creatinine ≤ 2 x ULN or estimated Glomerular Filtration Rate (Cockcroft Gault) ≥ 40 mL/min/1.73m2
- Competent to give an informed consent
You may not qualify if:
- Concomitant chronic liver diseases not related to HBV
- Known history of drug-induced liver injury, chronic active hepatitis C infection, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, on-going extra-hepatic obstruction caused by cholelithiasis, cirrhosis of the liver and portal hypertension
- Known history of drug induced pneumonitis
- Known history of inflammatory bowel disease
- Woman who are pregnant or breast-feeding
- Patients who do not consent to the use of effective contraception during the study
- Active infections.
- Evidence of ongoing active HBV hepatitis (ALT and/or AST \> 2x upper limit of normal, and detectable HBV DNA)
- Patients known to have histological transformation of CLL to an aggressive lymphoma
- Vaccinated with live, attenuated vaccines within 4 weeks of enrolment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Hong Konglead
- Janssen, LPcollaborator
Study Sites (1)
The University of Hong Kong
Hong Kong, Hong Kong
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yok Lam Kwong, MD(HK),
The University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair Professor
Study Record Dates
First Submitted
December 2, 2016
First Posted
December 13, 2016
Study Start
November 1, 2016
Primary Completion
December 1, 2020
Study Completion
June 1, 2021
Last Updated
April 12, 2018
Record last verified: 2018-04