PUL-042 Treatment in Patients With Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV)
Cancer-Related Syndrome
Hematopoietic Malignancies
Hodgkin Lymphoma
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes (MDS)
Non-Hodgkin Lymphoma
Plasma cell neoplasm
18 Years and older, Male and Female
PUL-042-207 (primary)
NCI-2024-09412
CP120014
Summary
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. The total duration of the study
will be approximately 30 days.
Objectives
A total of up to 100 participants will be enrolled in this research study, at up to 15
centers. Participants in the study will receive either PUL-042 or a placebo (an inactive
agent that appears identical to PUL-042). Patients will be randomized 1:1 for PUL-042 or
placebo.
The first 50 patients will either be low dose PUL-042 or placebo. After review of the
safety data from the initial patients, the PUL-042 dose may be increased. Subjects will
be evaluated by chest x-ray and clinical status for respiratory complications.
Eligibility
- Subjects 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 subjects must fulfill the following inclusion criteria to be eligible for participation in the study:
- Subjects 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, lymphoma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, multiple myeloma, and myelodysplastic and myeloproliferative disorder.
- Subjects who have undergone active cytotoxic chemotherapy within 6 months or subjects who are on an immunosuppressive therapy (e.g., alemtuzumab, ibrutinib, mycophenolate mofetil, corticosteroids =1mg/kg prednisone equivalent).
- Subjects 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.
- Subjects who are recipients of an autologous HSCT must be within 3 months of the transplant procedure.
- Subjects 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.
- Subjects 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 subjects of child-bearing potential who are capable of conception must be: practicing two effective methods of birth control (acceptable methods include intrauterine device, spermicide, barrier, male partner surgical sterilization, and hormonal contraception) during the study and through 30 days after completion of the study. Abstinence is not classified as an effective method of birth control.
- 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 Day 1.
- 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 30 days after completion of the study. Abstinence is not classified as an effective method of birth control.
- Ability to understand and give informed consent.
Treatment Sites in Georgia
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-851-8523
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