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Trial record 1 of 2 for:    ibrutinib | COVID | United States
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Ibrutinib for the Treatment of COVID-19 in Patients Requiring Hospitalization

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ClinicalTrials.gov Identifier: NCT04439006
Recruitment Status : Recruiting
First Posted : June 19, 2020
Last Update Posted : August 19, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Jennifer Woyach, Ohio State University Comprehensive Cancer Center

Brief Summary:
This phase Ib/II trial studies the side effects and best dose of ibrutinib and how well it works in treating patients with COVID-19 requiring hospitalization. Ibrutinib may help improve COVID-19 symptoms by lessening the inflammatory response in the lungs, while preserving overall immune function. This may reduce the need to be on a ventilator to help with breathing.

Condition or disease Intervention/treatment Phase
Aplastic Anemia Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Monoclonal B-Cell Lymphocytosis Monoclonal Gammopathy of Undetermined Significance Myelodysplastic Syndrome Symptomatic COVID-19 Infection Laboratory-Confirmed Other: Best Practice Drug: Ibrutinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Double-Blind Phase 2 Trial of Ibrutinib Versus Standard Treatment for COVID-19 Illness Requiring Hospitalization With Safety Lead-In
Actual Study Start Date : July 22, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
Experimental: Arm A (ibrutinib)
Patients receive ibrutinib PO QD on days 1-7. Treatment repeats every 7 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients who remain hospitalized or are re-admitted after 2 cycles may receive an additional 2 cycles per physician's discretion.
Drug: Ibrutinib
Given PO
Other Names:
  • BTK Inhibitor PCI-32765
  • CRA-032765
  • Imbruvica
  • PCI-32765

Active Comparator: Arm B (usual care)
Patients receive usual care.
Other: Best Practice
Receive usual care
Other Names:
  • standard of care
  • standard therapy




Primary Outcome Measures :
  1. Proportion of patients with diminished respiratory failure and death [ Time Frame: During hospitalization for COVID-19 infection or within 30 days of registration ]
    Associations between baseline characteristics and the primary endpoint will be evaluated with logistic regression, adjusting for arm. These analyses will be largely descriptive, as a result of a limited sample size.

  2. Death [ Time Frame: During hospitalization for COVID-19 infection or within 30 days of registration ]

Secondary Outcome Measures :
  1. Time from study initiation to 48 hours fever-free [ Time Frame: Up to 14 days ]
    Fever-free will be assessed by a temperature of < 100.5 degrees Fahrenheit orally. Will be estimated for each arm using the method of Kaplan-Meier. Medians estimates and/or estimates at specific time points will be provided with 95% confidence intervals.

  2. Duration of hospitalization [ Time Frame: Up to 14 days ]
    Will be estimated for each arm using the method of Kaplan-Meier. Medians estimates and/or estimates at specific time points will be provided with 95% confidence intervals.

  3. Time in intensive care unit (ICU) [ Time Frame: Up to 14 days ]
  4. Time to ICU admission [ Time Frame: Up to 14 days ]
  5. Number of days requiring supplemental oxygen [ Time Frame: Up to 14 days ]
  6. Total days of mechanical ventilation [ Time Frame: Up to 14 days ]
  7. Time to mechanical ventilation [ Time Frame: Up to 14 days ]
  8. Shock and need for pressure support [ Time Frame: Up to 14 days ]
  9. Incidence of any infection (viral, fungal, bacterial) [ Time Frame: Up to 14 days ]
  10. Time to clinical resolution [ Time Frame: Up to 14 days ]
  11. Incidence of grade 3 or higher adverse events [ Time Frame: Up to 12 months ]
    Adverse events will be summarized by grade, type, and attribution (regardless of attribution and treatment-related) for each arm.

  12. At the end of therapy (day 14) [ Time Frame: Up to 14 days ]
    The proportion of patients with viral clearance at the time of hospital discharge will be estimated with 95% confidence intervals for each arm.

  13. Time to viral clearance [ Time Frame: Up to 12 months ]
    Will be estimated for each arm using the method of Kaplan-Meier. Medians estimates and/or estimates at specific time points will be provided with 95% confidence intervals.

  14. Survival [ Time Frame: Up to12 months ]
    Patients will be followed for up to 12 months or until death or withdrawal of study consent for further follow-up. Following hospitalization, study visits will be telephone or video encounters.



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:

  • History or active diagnosis of cancer (solid or hematologic) or precursor of cancer (monoclonal gammopathy of undetermined significance [MGUS]), monoclonal B lymphocytosis (MBL), aplastic anemia or myelodysplastic syndrome) that is associated with immune suppression
  • Hospitalization for confirmed polymerase chain reaction (PCR) positive COVID-19 infection
  • Patients with evidence of pulmonary involvement who meet any of the followings; presence of infiltrates on chest X-ray or computed tomography (CT) scan or need for supplemental oxygen < 8 L nasal cannula or pulse oximetry < 94% on room air
  • Creatinine clearance >= 25 ml/min by Cockcroft-Gault equation
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN
  • Absolute neutrophil count (ANC) >= 1000/mm^3 independent of growth factor support
  • Platelets >= 50,000/mm^3
  • Ability to swallow capsules
  • Ability to provide informed consent indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study
  • Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree to not donate sperm during and after the study. For females, these restrictions apply for 1 month after the last dose of study drug. For males, these restrictions apply for 3 months after the last dose of study drug
  • Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening. Women who are pregnant or breastfeeding are ineligible for this study

Exclusion Criteria:

  • Active uncontrolled systemic bacterial or fungal infection
  • Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon)
  • Currently receiving BTK inhibitor therapy
  • Actively receiving anti-cancer therapy. All anti-cancer therapy must be stopped at the time of screening
  • Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association Functional classification requirement for mechanical ventilation at screening
  • Known bleeding disorders (e.g., Von Willebrand's disease, platelet storage pool disorders, or hemophilia)
  • Stroke or intracranial hemorrhage within 6 months of screening
  • Major surgery or non-healing wound within 4 weeks of enrollment
  • Concomitant administration of prohibited medications
  • Known history of human immunodeficiency virus (HIV), or active hepatitis B or C infection
  • Disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption (malabsorption syndrome, resection of the small bowel, poorly controlled inflammatory bowel disease, etc.)
  • Requires chronic treatment with strong CYP3A inhibitors

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): NCT04439006


Contacts
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Contact: Ohio State Comprehensive Cancer Center 1-800-293-5066 OSUCCCClinicaltrials@osumc.edu
Contact: Lauren Long lauren.long@osumc.edu

Locations
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United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Jennifer A. Woyach, MD    614-293-3196    Jennifer.woyach@osumc.edu   
Principal Investigator: Jennifer A. Woyach, MD         
Sponsors and Collaborators
Jennifer Woyach
National Cancer Institute (NCI)
Janssen Scientific Affairs, LLC
Investigators
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Principal Investigator: Jennifer A Woyach, MD Ohio State University Comprehensive Cancer Center
Additional Information:
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Responsible Party: Jennifer Woyach, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04439006    
Other Study ID Numbers: OSU-20135
NCI-2020-03341 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA016058 ( U.S. NIH Grant/Contract )
First Posted: June 19, 2020    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Laboratory Infection
Neoplasms
Myelodysplastic Syndromes
Anemia, Aplastic
Paraproteinemias
Monoclonal Gammopathy of Undetermined Significance
Lymphocytosis
Bone Marrow Diseases
Hematologic Diseases
Anemia
Blood Protein Disorders
Immunoproliferative Disorders
Immune System Diseases
Hypergammaglobulinemia
Leukocytosis
Leukocyte Disorders
Infection
Occupational Diseases