Extracorporeal Photopheresis for Medicare Recipients of Lung Allografts (NCT02181257) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Extracorporeal Photopheresis for Medicare Recipients of Lung Allografts
United States280 participantsStarted 2015-01
Plain-language summary
The primary aims of this study is to determine the efficacy and tolerability of Extracorporeal Photopheresis (ECP) for the treatment of either Refractory Bronchiolitis Obliterans Syndrome (BOS) patients (258 at cessation of enrollment April 7, 2022) or Newly Diagnosed (22 as of enrollment Hold February 2022) Bronchiolitis Obliterans Syndrome patients after lung transplantation. In compliance with the Centers for Medicare and Medicaid Services' (CMS) Coverage with Evidence Development (CED) decision, the study will collect specified demographic, comorbidity, treatment, and outcome data exclusively for Medicare beneficiaries who are treated with ECP for either refractory or New BOS.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age (18 years old or older).
✓. Medicare-eligible status
✓. Lung transplant recipient (combined organ transplant recipients, e.g. heart-lung or liver-lung or lung re- transplantation recipients are eligible).
✓. Patients with a diagnosis of BOS using at least two laboratory based FEV1 values obtained at least three weeks apart that are both at least 20% lower than baseline FEV1 using the International Society for Heart and Lung Transplantation (ISHLT) definition (The average of the two highest FEV1 measurements obtained at least 3 weeks apart after transplantation). The date of Diagnosis of New BOS is the first date of the two FEV1s that were used for the BOS diagnosis.
✓. Refractory BOS defined as ongoing decline in FEV1 despite at least one of the following treatments:
✓. At minimum five recorded FEV1 measurements obtained at intervals of at least two weeks apart, over the 9 months preceding study enrollment, of which one FEV1 must be within two weeks prior to enrollment.
✓. History of frequent spirometry monitoring defined as having had regular FEV1 measurements within the context of either of the following two options: (1) During the preceding four months prior to enrollment with no time interval between FEV1 measurements that exceeds 8 weeks. (2) During the preceding six months prior to enrollment with no time interval between FEV1 measurements that exceeds 12 weeks.
What they're measuring
1
REFRACTORY BOS: Change in the rate of FEV1 decline.
Timeframe: Baseline vs 12 months following the initiation of ECP.
2
NEW BOS: Cumulative All-cause mortality
Timeframe: 5 Years following randomization
3
NEW BOS: Change in the rate of FEV1 decline
Timeframe: Baseline vs 12 months following randomization
4
REFRACTORY BOS: All cause and CLAD related mortality
Timeframe: 5 years following enrollment or the initial ECP.
✓. A documented clinical assessment including a physical assessment and Complete Blood Count (CBC) with White Blood Cell Count (WBC) within two weeks prior to enrollment.
Exclusion criteria
✕. For patients who are monitored with laboratory based spirometry, at least five recorded FEV1 measurements obtained at intervals of at least two weeks apart, over either the 6 or 9 (i.e., depending on the frequency of spirometry testing) months preceding study enrollment accompanied by a statistically significant (p\<0.05) rate of decline of FEV1 that exceeds 30 mL/month; or
✕. For patients who are monitored with home Spirometry, 4-6 recorded home spirometry FEV1 measurements obtained one week apart, over the 4-6 weeks prior to a confirmed FEV1 variance (i.e., the date of the second of two consecutive FEV1 values below the patient's normal range) along with 4-6 recorded weekly FEV1 measurements obtained after a confirmed variance accompanied by a statistically significant (p\<0.05) rate of de-cline of FEV1 that exceeds 30 mL/month 7. Documented clinical assessment including a physical assessment and a CBC with WBC within two weeks prior to enrollment.
✕. Current participation in another clinical treatment trial with an investigational agent used to manage BOS before or after enrollment.
✕. Any condition that may interfere with the subject's ability to perform pulmonary function testing.
✕. Known allergy or hypersensitivity to pharmacologic agents used during ECP
✕. Any condition that would significantly affect the participant's ability to adhere to the protocol, affect interpretation of the study results, or put the participant at unacceptable risk for study-related complications as judged by the referring clinician. This may include a) patients with a specific acute contraindication to receiving ECP due to any acute condition such as new or evolving myocardial infarction or central nervous system disorder, hemodynamic instability or hypovolemia, acute bleeding, respiratory distress.
✕. Patients with lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum, albinism, or other dermatologic or ocular condition that contraindicates the use of methoxsalen or markedly enhances photosensitivity in the investigator's judgment.