Primary Eligibility:
- Diagnosis of bronchiolitis obliterans (BO) following allogeneic stem cell transplantation, must meet all of the following criteria:
- FEV1 < 75% of predicted by pulmonary function test (PFT) for height and weight
- Meet one of the following:
- FEV1/SVC ratio < 0.7 or < 5% of predicted
- Evidence of air-trapping on expiratory high resolution chest CT AND RV or RV/FVC > 120%
- Pathologic evidence of bronchiolar inflammation and obstruction of the lumen consistent with a diagnosis of BO
- No active infection
- Patients without pathologic evidence of BO must have one other sign of chronic graft-versus-host disease (cGVHD) present:
- A process distinct from that diagnosed as acute GVHD
- Presence of a diagnostic sign or a distinctive sign supported by another clinical or laboratory test
- Exclusion of other pathologies (i.e., recurrent cancer, drug reaction, or infection)
- Any patient who has been on a therapy for cGVHD for < 3 months will need to be monitored for 3 months AND demonstrate no improvement in FEV1 prior to study enrollment
- Stable or decreasing FEV1 on a therapeutic regimen for cGVHD for ≥ 3 months OR new onset drop in FEV1 without alteration in systemic cGVHD therapy
- No tumor burden greater than minimal residual disease (i.e., tumor burden that can only be detected by molecular methods)
- No prior treatment with montelukast or zakirlukast in the post-transplant period
- Prior treatment with bronchodilators or other pulmonary therapies allowed
- Karnofsky or Lansky performance status > 40%
- Age 6 years and older
- Total bilirubin < 3 x upper limit of normal (ULN) for age
- Transaminases < 5 x ULN for age
- LVEF > 25%
- FEV1 ≥ 20% of predicted
Treatment Plan:
This is a multicenter study. - Patients receive oral montelukast sodium once daily for 6 months in the absence of disease progression or unacceptable toxicity
- Blood and urine samples are collected at baseline and at 3 and 6 months
- Patients complete quality-of-life questionnaires at baseline and at 1, 3, 6, 12, and 24 months
- After completion of study treatment, patients are followed at 1 and 2 years
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers
Reviewed: 1/30/09
Updated: 7/15/08
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