Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant

• Status: Terminated
• Trial end date: 2013-12-30
• Target enrollment: 0
• Participant gender: All

Summary

For many patients with blood cancers, stem cell transplantation from a family member or from an unrelated donor remains the only potentially curative option. Unfortunately, up to 40% of patients develop chronic lung disease after the transplant, which substantially increases the risk of death in the long-term. Currently, patients with transplant-related lung disease are treated with some combination of steroids and other immunosuppressant drugs, but only about 1 out of 5 improve.

The importance of our study is that the investigators aim to prevent the development of transplant-related chronic lung disease in the first place. Because a strong risk factor for such chronic lung disease is a prior viral respiratory tract infection, the investigators think there is a window of opportunity to intervene. As soon as "cold and flu" symptoms start, the investigators will treat patients with a combination of drugs aimed at eliminating damaging immune responses triggered by the virus. In the absence of such treatment, the investigators believe these lung-damaging immune responses would persist even after the virus disappears. Our hope is that preventive treatment might avoid the development of chronic lung disease, and this would substantially increase long-term survival in our transplant patients.

This is a pilot study. Once feasibility is established, the investigators will seek to expand this study into a definitive clinical trial.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maisonneuve-Rosemont Hospital
• Collaborator: The Canadian Blood and Marrow Transplant Group
• Treatments: Azithromycin; Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Formoterol Fumarate; Montelukast; Prednisone

Criteria

Inclusion Criteria:

• Allogeneic transplant within the prior 1 year

• Age greater than or equal to 18 years

• Capable of informed consent

• Neutrophil engraftment has occurred

• This is the first clinically-recognized episode of viral respiratory tract infection after transplant

Exclusion Criteria:

• Proof or high suspicion for bacterial, fungal or any non-viral microorganism causing pneumonia

• CMV, VZV or HSV pneumonia

• Prior diagnosis of a chronic transplant-related non-infectious pulmonary complication (ex: BO, COP)

• Treating physician believes the risk of systemic steroids is too great

• Currently receiving prednisone at or greater than 0.25 mg/kg/day or the equivalent dose of another steroid

• Currently receiving pentostatin

• Mycophenolate initiated de novo or increased within the past 4 weeks

• Use of inhaled corticosteroids within the past 2 weeks for at least 1 week

• Haploidentical or T-cell depleted graft

• Lack of pre-transplant pulmonary function tests

• Evidence of a prior symptomatic viral respiratory tract infection following transplant, whether treated or not

• Allergy or adverse reaction to any of the study drugs

• Relapse or progression of the underlying malignancy

• Palliative care