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New treatment option for Hematologic Malignancies
Official title PUL-042 Treatment in Patients With Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV)
ClinicalTrials.gov ID: NCT06665100
What this study is testing
What is PUL-042?
PUL-042 is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for hematologic malignancies.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this research study is to try to see whether an experimental drug, PUL 042 Inhalation Solution (PUL 042), is effective in reducing the severity of lung infections in patients with hematologic malignancies and recipients of hematopoietic stem cell transplantation with documented viral infections due to PIV, hMPV, or RSV. PUL-042 or a placebo will be administered 3 times over a 6-day period.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people will be eligible for entry into the study if a nasopharyngeal swab is positive for PIV, RSV, or hMPV (as a single pathogen or a mixed...
- people with hematologic malignancies (i.e., leukemia, lymphoma, or multiple myeloma) or recipients of an allogeneic or autologous hematopoietic stem...
- people who have undergone active cytotoxic chemotherapy within 6 months or people who are on an immunosuppressive therapy (e.g., alemtuzumab...
- people who are recipients of an allogeneic hematopoietic stem cell transplant (HSCT) must be deemed high risk with an Immunodeficiency Scoring Index...
- people who are recipients of an autologous HSCT must be within 3 months of the transplant procedure.
You likely can't join if
- people will be excluded if they fulfill any of the following exclusion criteria:
- Patients with a pulse oximetry of hemoglobin saturation less than 93% on room air.
- Known history of chronic pulmonary disease (e.g., asthma [including atopic asthma, exercise-induced asthma, or asthma triggered by respiratory...
- people treated for fungal, viral, or bacterial pneumonia in the previous 30 days.
- Exposure to any investigational agent (defined as any non-FDA-approved agent) within 30 days, or 5 half-lives of the investigational agent, whichever...
- Allogeneic HSCT recipients with an ISI of 3 or less.
See the full eligibility criteria
- people will be eligible for entry into the study if a nasopharyngeal swab is positive for PIV, RSV, or hMPV (as a single pathogen or a mixed infection with rhinovirus) by molecular assay by a local laboratory AND people...
- people with hematologic malignancies (i.e., leukemia, lymphoma, or multiple myeloma) or recipients of an allogeneic or autologous hematopoietic stem cell transplantation for one of the following diagnoses: leukemia...
- people who have undergone active cytotoxic chemotherapy within 6 months or people who are on an immunosuppressive therapy (e.g., alemtuzumab, ibrutinib, mycophenolate mofetil, corticosteroids ≥1mg/kg prednisone...
- people who are recipients of an allogeneic hematopoietic stem cell transplant (HSCT) must be deemed high risk with an Immunodeficiency Scoring Index (ISI) , of greater or equal to 4.
- people who are recipients of an autologous HSCT must be within 3 months of the transplant procedure.
- people must be symptomatic with upper or lower respiratory tract symptoms such as rhinorrhea, sore throat or cough and must be dosed within 6 days from the onset of symptoms.
- Chest X-ray with a Radiologic Severity Index (RSI) score of 6 or lower.
- people must have pulse oximetry of hemoglobin saturation ≥ 93% on room air.
- Spirometry (forced expiratory volume in one second [FEV1] and forced vital capacity [FVC]) ≥70% of predicted value.
- Adult (≥ 18 years of age).
- If female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female people of child-bearing potential who are capable of conception must be: practicing two effective...
- If female, must not be pregnant, plan to become pregnant, or nurse a child during the study and through 30 days after completion of the study. A pregnancy test must be negative at the Screening Visit, prior to dosing on...
- If male, must be surgically sterile or willing to practice two effective methods of birth control (acceptable methods include barrier, spermicide, or female partner surgical sterilization) during the study and through...
- Ability to understand and give informed consent.
- people will be excluded if they fulfill any of the following exclusion criteria:
- Patients with a pulse oximetry of hemoglobin saturation less than 93% on room air.
- Known history of chronic pulmonary disease (e.g., asthma [including atopic asthma, exercise-induced asthma, or asthma triggered by respiratory infection], chronic pulmonary disease, pulmonary fibrosis, COPD), pulmonary...
- people treated for fungal, viral, or bacterial pneumonia in the previous 30 days.
- Exposure to any investigational agent (defined as any non-FDA-approved agent) within 30 days, or 5 half-lives of the investigational agent, whichever is longer, prior to the Screening Visit.
- Allogeneic HSCT recipients with an ISI of 3 or less.
- Autologous HSCT recipients more than 3 months after the transplant procedure.
- Patients with a relapsed and/or refractory underlying hematologic malignancy with a life expectancy of less than 2 months.
- HSCT recipients in the pre-engraftment period.
- Chest X-ray with an RSI of \>6.
- Patients documented to be positive for other respiratory viruses (limited to influenza, SARS-CoV-2, adenovirus, or coronavirus) within 7 days prior to the Screening Visit, as determined by local testing (additional...
- Clinically significant bacteremia or fungemia within 7 days prior to the Screening Visit that has not been adequately treated, as determined by the Principal Investigator.
- Any condition which, in the opinion of the Principal Investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints.
- Previous exposure to PUL-042 Inhalation Solution.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Atlanta, Georgia, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- Hackensack, New Jersey, United States
- Chapel Hill, North Carolina, United States
- Oklahoma City, Oklahoma, United States
- Houston, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Atlanta, Georgia, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States; Detroit, Michigan, United States; Minneapolis, Minnesota, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.