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

NCT ID: NCT01432080

Last Updated: 2021-10-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-12-30

Brief 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.

Conditions

Respiratory Tract Infections; Bronchiolitis Obliterans; Cryptogenic Organizing Pneumonia; Lung Diseases, Interstitial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard of Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

SAMS

Subjects randomized to the SAMS arm will receive a four-drug combination (Steroids, Azithromycin, Montelukast, and Symbicort).

Group Type: EXPERIMENTAL

Prednisone

Intervention Type: DRUG

Prednisone 0.75 mg/kg actual body weight/day PO for 7 days followed by a 7 day taper.

Azithromycin

Intervention Type: DRUG

Azithromycin 250 mg PO daily for 2 weeks, then 3 times per week until 3 months

Montelukast

Intervention Type: DRUG

Montelukast 10 mg PO qhs for 3 months

Symbicort

Intervention Type: DRUG

Symbicort 200/6 mcg, 2 inhalations every 12 hours for 3 months

Interventions

Prednisone

Prednisone 0.75 mg/kg actual body weight/day PO for 7 days followed by a 7 day taper.

Intervention Type: DRUG

Azithromycin

Azithromycin 250 mg PO daily for 2 weeks, then 3 times per week until 3 months

Intervention Type: DRUG

Montelukast

Montelukast 10 mg PO qhs for 3 months

Intervention Type: DRUG

Symbicort

Symbicort 200/6 mcg, 2 inhalations every 12 hours for 3 months

Intervention Type: DRUG

Other Intervention Names

Deltasone; Steroids; Singulair; Budesonide; Formoterol

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Canadian Blood and Marrow Transplant Group

NETWORK

Sponsor Role: collaborator

Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Krakow

Fellow in Hematopoietic Cell Transplantation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth F Krakow, MD,CM, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Maisonneuve-Rosemont Hospital

Sandra Cohen, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Maisonneuve-Rosemont Hospital

Locations

Maisonneuve-Rosemont Hospital (Hôpital Maisonneuve-Rosemont)

Montreal, Quebec, Canada

Countries

Canada

Related Links

http://gmo-hmr.org/en/index.php

Maisonneuve-Rosemont Hospital's Stem Cell Transplant Program

Other Identifiers

HMR1102

Identifier Type: -

Identifier Source: org_study_id