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Not meeting recruitment targets
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| Name | Class |
|---|---|
| The Canadian Blood and Marrow Transplant Group | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | No Intervention | Standard of Care includes fluids, antipyretics, ribavirin for RSV infection, and oseltamivir for influenza infection, and intravenous immune globulin for patients with low IgG levels. | |
| SAMS | Experimental | Subjects randomized to the SAMS arm will receive a four-drug combination (Steroids, Azithromycin, Montelukast, and Symbicort). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug | Prednisone 0.75 mg/kg actual body weight/day PO for 7 days followed by a 7 day taper. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of new chronic lung disease | The incidence rate of new non-infectious pulmonary complications within the 6 month follow-up period will be calculated. Non-infectious pulmonary complications include new airflow obstruction, new restrictive lung disease, and new mixed obstruction/restriction as measured by spirometry at study enrolment, 2 and 8 weeks following viral infection, and by full pulmonary function tests at 3 and 6 weeks following viral infection. | 6 months following diagnosis of the viral respiratory tract infection |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of non-infectious pulmonary complications | Non-infectious pulmonary complications (NIPCs) include airflow obstruction, restrictive lung disease, and mixed obstruction/restriction as determined by pulmonary function tests. The prevalence of NIPCs will be determined among subjects surviving to 6 months post viral respiratory tract infection. | 6 months following the diagnosis of viral respiratory tract infection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth F Krakow, MD,CM, FRCPC | Maisonneuve-Rosemont Hospital | Principal Investigator |
| Sandra Cohen, MD, FRCPC | Maisonneuve-Rosemont Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maisonneuve-Rosemont Hospital (Hôpital Maisonneuve-Rosemont) | Montreal | Quebec | H1T 2M4 | Canada |
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| Label | URL |
|---|---|
| Maisonneuve-Rosemont Hospital's Stem Cell Transplant Program | View source |
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| Azithromycin | Drug | Azithromycin 250 mg PO daily for 2 weeks, then 3 times per week until 3 months |
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| Montelukast | Drug | Montelukast 10 mg PO qhs for 3 months |
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| Symbicort | Drug | Symbicort 200/6 mcg, 2 inhalations every 12 hours for 3 months |
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| Long-term functional impairment as defined by need for supplemental oxygen | The percentage of subjects needing at least 1 month of supplemental oxygen on most days per week, not counting the period of symptomatic viral respiratory tract infection, will be determined in both arms. | 6 months post viral respiratory tract infection |
| Patient-perceived long-term functional impairment | A FACT-BMT questionnaire will be administered at baseline and again to subjects surviving 6 months post respiratory tract infection to measure patient-perceived functional impairment. | 6 months post viral respiratory tract infection |
| Time to clearance of viral infection | Subjects in whom a respiratory virus is detected will undergo repeat testing every 2 weeks until the virus is no longer detectable. This is an exploratory analysis. The natural history of many of these community-acquired viruses in the transplant population is not known. | Every 2 weeks until virus is no longer detectable |
| Incidence of progression to respiratory failure | This endpoint includes admission to hospital because of documented desaturation, need for supplemental oxygen, and need for mechanical ventilation. | 21 days after enrolment |
| Incidence of bacterial or fungal superinfection | The incidence of secondary bacterial and fungal pneumonias will be compared in the two arms, to verify that the added immunosuppression does not contribute to further infectious complications. | Within 21 days after enrolment |
| Incidence of various other infectious complications | The incidence of various other infectious complications, specifically including but not limited to CMV reactivations and CMV disease, zoster, and septicemia will be monitored in both arms. | Within 6 months after enrolment |
| Overall survival from date of viral respiratory tract infection | 3 months post enrolment |
| Overall survival from date of viral respiratory tract infection | 6 months post enrolment |
| Overall survival from date of transplant to end of study follow-up | 6 months post enrolment |
| Overall survival at 1 year post-transplant | This measure will be applied to the group overall and also analyzed according to subgroups of patients presenting viral respiratory tract infections within 30 days of transplant, 31-100 days of transplant, and 101-365 days of transplant. | 1 year post-transplant |
| Cumulative incidence of death attributable to transplant associated lung disease | 6 months post enrolment |
| Cumulative incidence of death from other causes | 6 months post enrolment |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D001989 | Bronchiolitis Obliterans |
| D018549 | Cryptogenic Organizing Pneumonia |
| D017563 | Lung Diseases, Interstitial |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D000092124 | Organizing Pneumonia |
| D054988 | Idiopathic Interstitial Pneumonias |
| D054990 | Idiopathic Pulmonary Fibrosis |
| D011658 | Pulmonary Fibrosis |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| D013256 | Steroids |
| D017963 | Azithromycin |
| C093875 | montelukast |
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| D019819 | Budesonide |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D000588 | Amines |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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