Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients

NCT04712539 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2020-0919NCI-2020-13918
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies the effect of baloxavir in combination with oseltamivir in treating severe influenza infection in patients who have previously received a hematopoietic (blood) stem cell transplant or have a hematological malignancy. Baloxavir is an antiviral drug that inhibits the growth of influenza virus, reduces viral load and prevents further influenza infection. Osetamivir is an antiviral drug that blocks enzymes on the surfaces of influenza viruses, interfering with cell release of complete viral particles. Giving baloxavir in combination with oseltamivir may shorten or decrease the intensity of influenza infection compared to oseltamivir alone.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Influenza

Outcome Measures

Primary Outcomes (2)

• Changes in viral loads

  Will be measured via repeat nasopharyngeal swabs at each follow up on day 0, 1, 3, 7, 14 and 30 for influenza quantification.

  On day 0, 1, 3, 7, 14, and 30

• Incidence of complicated hospital stay

  Defined as a hospital admission that was either prolonged (greater than 7 days), requiring intensive care unit level of care or death at day 30 as a result of influenza infection.

  Up to 30 days

Secondary Outcomes (7)

• Rate of resistance to antiviral agents

  Up to 30 days

• Progression to lower respiratory tract infections

  Up to 30 days

• Length of hospital stay

  Up to 30 days

• Oxygen requirement

  Up to 30 days

• Rate of respiratory failure

  Up to 30 days

Study Arms (2)

Arm I (oseltamivir, baloxavir marboxil)

EXPERIMENTAL

Patients receive oseltamivir PO BID for up to 10 days and baloxavir marboxil PO every 72 hours for a total of 3 doses in the absence of disease progression or unacceptable toxicity.

Drug: Baloxavir Marboxil; Drug: Oseltamivir

Arm II (oseltamivir)

ACTIVE COMPARATOR

Patients receive oseltamivir PO BID for up to 10 days in the absence of disease progression or unacceptable toxicity.

Drug: Oseltamivir

Interventions

Baloxavir Marboxil DRUG

Given PO

Also known as: BXM, Xofluza

Arm I (oseltamivir, baloxavir marboxil)

Oseltamivir DRUG

Given PO

Arm I (oseltamivir, baloxavir marboxil); Arm II (oseltamivir)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Hematopoeitic cell transplant recipients OR hematological malignancy patients
• Diagnosed with influenza ⱡ
• Evidence of LRTI\* or high risk upper respiratory tract infection (URTI)\*\*
• ⱡ A positive multiplex PCR for influenza is required to confirm a diagnosis of influenza infection.
• \* LRTI will be defined as influenza cases that have evidence of disease below the level of the trachea on either imaging only (possible LRTI), imaging and microbiological evidence of lower airway disease with a bronchoscopy (probable LRTD) or pathological evidence of disease via biopsy (proven LRTI).
• \*\* High risk URI will be defined as those cases of influenza that do not have microbiological nor radiological evidence of LRTI, yet they have an immunodeficiency scoring index (ISI) of 3 or greater as defined by Shah D et al (19) for HCT recipients or severe neutropenia (ANC ≤500 cells/ml) and/or lymphopenia (ALC ≤200 cells/ml) for HM patients.

You may not qualify if:

• Patient requires mechanical ventilation at time of enrollment
• Patient is younger than the age of 12 years old
• The patient is unable to tolerate oral therapy
• The patient is pregnant at screening ( Positive serum β-HCG (beta-human chorionic gonadotropin) test for women of child-bearing potential).
• The patient is on a prohibited medication. These include Influenza antiviral drugs with the exception of oseltamivir and baloxavir (such as peramivir, laninamivir, zanamivir, rimantadine, umifenovir or amantadine) and herbal therapies.
• The patient is unable to consent will be excluded

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Hematologic Neoplasms; Influenza, Human

Interventions

baloxavir; Oseltamivir

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Roy F Chemaly, MD,MPH

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roy F. Chemaly, MD,MPH

CONTACT

713-792-6830; rfchemaly@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: October 11, 2021
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: February 11, 2026

Record last verified: 2026-01

Locations

US (1)