Overview

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