A Phase I Study to Assess Safety of Selective JAK 1 Inhibitor, Itacitinib, in Patients With Bronchiolitis Obliterans Syndrome (BOS) After Allogeneic Hematopoietic Cell Transplant (HCT)

  • STATUS
    Recruiting
  • End date
    May 31, 2024
  • participants needed
    15
  • sponsor
    M.D. Anderson Cancer Center
Updated on 22 October 2022

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.

Description

PRIMARY OBJECTIVE:

I. To assess the safety of itacitinib in patients with bronchiolitis obliterans syndrome (BOS) after allogeneic hematopoietic cell transplantation (HCT).

SECONDARY OBJECTIVES:

I. To assess treatment failure at 3 months and 6 months. II. To assess change in symptom-based lung score at 3 months and 6 months. III. To assess change in the St. George Respiratory Questionnaire and Study Short Form 36 at 3 months and 6 months.

IV. To assess change in the Lee chronic graft versus host disease (GVHD) symptom scale at 3 months and 6 months post-treatment.

V. To assess change in 6-minute walk test at 3 months and 6 months. VI. To assess failure-free survival at 6 months. VII. To assess non-relapse mortality at 6 months. VIII. To assess overall survival at 6 months.

OUTLINE

Patents receive itacitinib orally (PO) once daily (QD) for up to 1 year in the absence of disease progression or unacceptable toxicity.

Details
Condition Bronchiolitis Obliterans
Treatment itacitinib, Itacitinib Adipate
Clinical Study IdentifierNCT04239989
SponsorM.D. Anderson Cancer Center
Last Modified on22 October 2022

Eligibility

Yes No Not Sure

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)
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