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Itacitinib for the Treatment of Bronchiolitis Obliterans Syndrome After Donor Hematopoietic Cell Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04239989
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This phase I trial studies how well itacitinib works for the treatment of bronchiolitis obliterans syndrome after donor hematopoietic cell transplant. Itacitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Condition or disease Intervention/treatment Phase
Bronchiolitis Obliterans Drug: Itacitinib Drug: Itacitinib Adipate Phase 1

Detailed Description:

PRIMARY OBJECTIVE:

I. To assess the safety of itacitinib in patients with bronchiolitis obliterans syndrome (BOS) after allogeneic hematopoietic cell transplantation (HCT).

SECONDARY OBJECTIVES:

I. To assess treatment failure at 3 months and 6 months. II. To assess change in symptom-based lung score at 3 months and 6 months. III. To assess change in the St. George Respiratory Questionnaire and Study Short Form 36 at 3 months and 6 months.

IV. To assess change in the Lee chronic graft versus host disease (GVHD) symptom scale at 3 months and 6 months post-treatment.

V. To assess change in 6-minute walk test at 3 months and 6 months. VI. To assess failure-free survival at 6 months. VII. To assess non-relapse mortality at 6 months. VIII. To assess overall survival at 6 months.

OUTLINE:

Patents receive itacitinib orally (PO) once daily (QD) for up to 1 year in the absence of disease progression or unacceptable toxicity.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Estimated Study Start Date : May 31, 2020
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment (itacitinib)
Patents receive itacitinib PO QD for up to 1 year in the absence of disease progression or unacceptable toxicity.
Drug: Itacitinib
Given PO
Other Names:
  • INCB 039110
  • INCB-039110
  • INCB039110

Drug: Itacitinib Adipate
Given PO
Other Names:
  • INCB-039110 Adipate
  • INCB039110 Adipate




Primary Outcome Measures :
  1. Monitoring the Dose Limiting Toxicities (DLT) of administering Itacitinib [ Time Frame: Up to 6 months ]
    Number of participants who develop DLT's after the administration of the study drug


Secondary Outcome Measures :
  1. Treatment failure [ Time Frame: At 3 and 6 months ]
    Defined as a decrease in the absolute value of % forced expiratory volume in 1 second (FEV1) by 10% or more.

  2. Changes in National Institutes of Health (NIH) symptom-based lung score [ Time Frame: At 3 and 6 months ]
    Improvement in NIH symptom-based lung score; Score 0 (no symptoms), Score 1 (shortness of breath with stairs), Score 2 (shortness of breath on flat ground), and Score 3 (shortness of breath at rest or requiring oxygen

  3. 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 ]
    Will include the St. George's Respiratory Questionnaire (SGRQ Regression models will include time, and different covariance structures will be included, including unstructured and autoregressive integrated moving average (ARIMA). The analysis will be adjusted for potential confounding variables. Participants will answer a St. George's Respiratory Questionnaire. (Very Poor, Poor, Fair, Good, Very Good)?

  4. Change in well-established patient reported outcomes used in chronic graft versus host disease (GVHD) studies [ Time Frame: Baseline up to 6 months ]
    Will include the Lee chronic GVHD symptom scale Lee symptom scale. Regression models will include time, and different covariance structures will be included, including unstructured and autoregressive integrated moving average (ARIMA). The analysis will be adjusted for potential confounding variables. The Lee Chronic GVHD Symptom Scale is a 30 item instrument with 7 subscales (skin, eyes, mouth, lung, nutrition, energy and psych) containing 2-7 items. Response options range from 0-4 (0-Not at all, 1-Slightly, 2-Moderately, 3-Quite a bit, 4-Extremely).

  5. 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 ]
    Will include the study Short Form 36 (SF-36), NIH lung symptom score and SF-36 due to the longitudinal nature of the observations. Regression models will include time, and different covariance structures will be included, including unstructured and autoregressive integrated moving average (ARIMA). The analysis will be adjusted for potential confounding variables.

  6. Change in 6-minute walk test [ Time Frame: Baseline and at 3 and 6 months ]
  7. Failure-free survival [ Time Frame: At 6 months ]
    Will be assessed and monitored

  8. Non-relapse mortality [ Time Frame: At 6 months ]
    Defined as the absence of need for additional line treatment, non-relapse mortality and recurrent malignancy.

  9. Overall survival [ Time Frame: At 6 months ]
    Will be assessed and monitored



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04239989


Contacts
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Contact: Rohtesh S. Mehta 713-792-8750 rmehta1@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Contact: Rohtesh S. Mehta    713-792-8750      
Principal Investigator: Rohtesh S. Mehta         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Rohtesh S Mehta M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04239989    
Other Study ID Numbers: 2018-0489
NCI-2019-08252 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0489 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bronchiolitis
Bronchiolitis Obliterans
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections