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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 11 January 2021
Main ID:  NCT04239989
Date of registration: 30/12/2019
Prospective Registration: Yes
Primary sponsor: M.D. Anderson Cancer Center
Public title: Itacitinib for the Treatment of Bronchiolitis Obliterans Syndrome After Donor Hematopoietic Cell Transplant
Scientific title: A Phase I Study to Assess Safety of Selective JAK 1 Inhibitor, Itacitinib, in Patients With Bronchiolitis Obliterans Syndrome (BOS) After Allogeneic Hematopoietic Cell Transplant (HCT)
Date of first enrolment: December 15, 2020
Target sample size: 15
Recruitment status: Not yet recruiting
URL:  https://clinicaltrials.gov/show/NCT04239989
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
United States
Contacts
Name:     Rohtesh S. Mehta
Address: 
Telephone: 713-792-8750
Email:
Affiliation: 
Name:     Rohtesh S. Mehta
Address: 
Telephone: 713-792-2802
Email: rmehta1@mdanderson.org
Affiliation: 
Name:     Rohtesh S Mehta
Address: 
Telephone:
Email:
Affiliation:  M.D. Anderson Cancer Center
Key inclusion & exclusion criteria

Inclusion Criteria:

- BOS diagnosed within the past 6 months of enrollment, defined by 2015 National
Institutes of Health (NIH) Consensus Criteria

- Undergone allogeneic stem cell transplant (SCT)

- Absolute neutrophil count (ANC) > 1,000/microL

- Hemoglobin > 8 gm/dL (untransfused)

- Platelet count > 25,000/microL (untransfused)

- Karnofsky performance score >= 60

- The ability to understand and sign a written informed consent form

Exclusion Criteria:

- Prior treatment with any other JAK inhibitor (including ruxolitinib) for BOS or any
other indication within the past 6 months of enrollment

- Patients on mechanical ventilation or resting by pulse oximetry oxygen (O2) saturation
< 88%

- Forced expiratory volume in 1 second (FEV1) < 40% predicted

- Relapsed primary malignancy for which SCT was performed

- History of progressive multifocal leuko-encephalopathy (PML)

- Active uncontrolled bacterial, fungal, parasitic, or viral infection

- Known human immunodeficiency virus (HIV) infection or active hepatitis B or C
infections

- History of tuberculosis anytime after SCT

- Severe renal dysfunction defined by serum creatinine > 2 mg/dL, creatinine clearance <
60 mL/minute or dialysis dependence

- Serum transaminases > 5 x upper limit of normal

- Inability to perform pulmonary function test (PFT) reliably

- Positive beta human chorionic gonadotropin (HCG) test in a woman with child bearing
potential defined as not post-menopausal for 12 months or no previous surgical
sterilization

- Life expectancy < 6 months

- Concurrent treatment with antiplatelet agents (aspirin, non-steroidal
anti-inflammatory drug [NSAIDs] and related drugs) or anticoagulants (warfarin,
heparin, oral anticoagulants - direct thrombin or anti Xa agents and related drugs)



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Bronchiolitis Obliterans
Intervention(s)
Drug: Itacitinib
Drug: Itacitinib Adipate
Primary Outcome(s)
Monitoring the Dose Limiting Toxicities (DLT) of administering Itacitinib [Time Frame: Up to 6 months]
Secondary Outcome(s)
Change in 6-minute walk test [Time Frame: Baseline and at 3 and 6 months]
Change in well-established patient reported outcomes used in chronic graft versus host disease (GVHD) studies [Time Frame: Baseline and at 3 and 6 months]
Change in well-established patient reported outcomes used in chronic graft versus host disease (GVHD) studies [Time Frame: Baseline up to 6 months]
Changes in National Institutes of Health (NIH) symptom-based lung score [Time Frame: At 3 and 6 months]
Failure-free survival [Time Frame: At 6 months]
Non-relapse mortality [Time Frame: At 6 months]
Overall survival [Time Frame: At 6 months]
Treatment failure [Time Frame: At 3 and 6 months]
Secondary ID(s)
2018-0489
NCI-2019-08252
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Cancer Institute (NCI)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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