ClinicalTrials.Veeva

Menu

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

M.D. Anderson Cancer Center logo

M.D. Anderson Cancer Center

Status and phase

Active, not recruiting
Phase 1

Conditions

Bronchiolitis Obliterans

Treatments

Drug: Itacitinib
Drug: Itacitinib Adipate

Study type

Interventional

Funder types

Other

Identifiers

NCT04239989
2018-0489 (Other Identifier)
NCI-2019-08252 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. BOS diagnosed within the past 6 months of enrollment, defined by 2015 National Institutes of Health (NIH) Consensus Criteria 126
  2. Age 18-75 years
  3. Undergone allogeneic SCT
  4. ANC >1,000/µL, hemoglobin > 8 gm/dL (untransfused) and platelet count >25,000/ µL (untransfused)
  5. Karnofsky performance score >60
  6. The ability to understand and sign a written informed consent form
  7. Contraception for women and men of child bearing potential. Permitted methods should be at least 99% effective in preventing pregnancy.
  8. Male patients must be willing to refrain from donating sperm during their participation in the study and for at least 3 months after completing the study.

Exclusion criteria

  1. Prior treatment with any other JAK inhibitor (including Ruxolitinib) for BOS or any other indication within the past 6 months of enrolment.
  2. Patients on mechanical ventilation or resting by pulse oximetry O2 saturation <88%
  3. FEV1 <40% predicted
  4. Relapsed primary malignancy for which SCT was performed
  5. History of progressive multifocal leuko-encephalopathy (PML)
  6. Active uncontrolled bacterial, fungal, parasitic, or viral infection
  7. Known human immunodeficiency virus (HIV) infection or active hepatitis B or C infections.
  8. History of tuberculosis anytime after SCT
  9. Severe renal dysfunction defined by serum creatinine > 2 mg/dL, creatinine clearance <60 mL/minute or dialysis dependence
  10. Serum transaminases > 5 × upper limit of normal
  11. inability to perform PFT reliably
  12. Positive Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
  13. Lactating/nursing women
  14. Life expectancy < 6 months
  15. Other severe organ dysfunction unrelated to underlying GVHD. For example, uncontrolled or significant cardiac disease, including any of the following: recent myocardial infarction (within last 6 months from randomization); New York Heart Association Class III or IV congestive heart failure; unstable angina (within last 6 months prior to randomization); clinically significant (symptomatic) cardiac arrhythmias (e.g., sustained ventricular; tachycardia, and clinically significant second or third degree AV block without a pacemaker); uncontrolled hypertension. Or any other concurrent severe and/or uncontrolled medical conditions which, in the opinion of the investigator, could compromise participation in the study, pose a significant risk to the subject, or interfere with study results.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

8 participants in 1 patient group

Treatment (itacitinib)
Experimental group
Description:
Patents receive itacitinib PO QD for up to 1 year in the absence of disease progression or unacceptable toxicity.
Treatment:
Drug: Itacitinib Adipate
Drug: Itacitinib

Trial contacts and locations

1

Loading...

Central trial contact

Amin Alousi, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems