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Does Increasing Immunosuppression Prevent Transplant-associated Lung-disease Triggered by Viral Respiratory Tract Infection Following Allogeneic Stem Cell Transplant? A Pilot Study


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Respiratory Tract Infections, Bronchiolitis Obliterans, Cryptogenic Organizing Pneumonia, Lung Diseases, Interstitial

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Trial Information

Does Increasing Immunosuppression Prevent Transplant-associated Lung-disease Triggered by Viral Respiratory Tract Infection Following Allogeneic Stem Cell Transplant? A Pilot Study


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Cumulative incidence of new chronic lung disease

Outcome Description:

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.

Outcome Time Frame:

6 months following diagnosis of the viral respiratory tract infection

Safety Issue:

No

Principal Investigator

Elizabeth F Krakow, MD,CM, FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Maisonneuve-Rosemont Hospital

Authority:

Canada: Ethics Review Committee

Study ID:

HMR1102

NCT ID:

NCT01432080

Start Date:

September 2011

Completion Date:

Related Keywords:

  • Respiratory Tract Infections
  • Bronchiolitis Obliterans
  • Cryptogenic Organizing Pneumonia
  • Lung Diseases, Interstitial
  • Pulmonary disease, chronic obstructive
  • Viral respiratory tract infections
  • Respiratory syncytial viruses
  • Influenza virus A
  • Influenza virus B
  • Transplantation, Allogeneic
  • Bronchiolitis
  • Bronchiolitis Obliterans
  • Lung Diseases
  • Pneumonia
  • Respiratory Tract Infections
  • Lung Diseases, Interstitial
  • Cryptogenic Organizing Pneumonia

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