Itacitinib for the Treatment of Bronchiolitis Obliterans Syndrome After Donor Hematopoietic Cell Transplant

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase I trial studies how well itacitinib works for the treatment of bronchiolitis obliterans syndrome after donor hematopoietic cell transplant. Itacitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• BOS diagnosed within the past 6 months of enrollment, defined by 2015 National Institutes of Health (NIH) Consensus Criteria

• Undergone allogeneic stem cell transplant (SCT)

• Absolute neutrophil count (ANC) > 1,000/microL

• Hemoglobin > 8 gm/dL (untransfused)

• Platelet count > 25,000/microL (untransfused)

• Karnofsky performance score >= 60

• The ability to understand and sign a written informed consent form

Exclusion Criteria:

• Prior treatment with any other JAK inhibitor (including ruxolitinib) for BOS or any other indication within the past 6 months of enrollment

• Patients on mechanical ventilation or resting by pulse oximetry oxygen (O2) saturation < 88%

• Forced expiratory volume in 1 second (FEV1) < 40% predicted

• Relapsed primary malignancy for which SCT was performed

• History of progressive multifocal leuko-encephalopathy (PML)

• Active uncontrolled bacterial, fungal, parasitic, or viral infection

• Known human immunodeficiency virus (HIV) infection or active hepatitis B or C infections

• History of tuberculosis anytime after SCT

• Severe renal dysfunction defined by serum creatinine > 2 mg/dL, creatinine clearance < 60 mL/minute or dialysis dependence

• Serum transaminases > 5 x upper limit of normal

• Inability to perform pulmonary function test (PFT) reliably

• Positive beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization

• Life expectancy < 6 months

• Concurrent treatment with antiplatelet agents (aspirin, non-steroidal anti-inflammatory drug [NSAIDs] and related drugs) or anticoagulants (warfarin, heparin, oral anticoagulants - direct thrombin or anti Xa agents and related drugs)