Status:
UNKNOWN
Efficacy and Safety of Low-dose Ibrutinib and Itraconazole in Chronic Graft Versus Host Disease
Lead Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Conditions:
Chronic Graft-versus-host-disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Chronic graft-versus-host disease (cGVHD) affects 30 to 70% of Allogeneic Hematopoietic Cell Transplantation, decreases the quality of life, and increases mortality. First-line treatments for cGVHD ar...
Detailed Description
In this phase 2 clinical trial, patients with newly diagnosed cGVHD and refractory cGVHD will receive low-dose ibrutinib (140mg/day) combined with a cytochrome 3A4 inhibitor (itraconazole, 100mg BID) ...
Eligibility Criteria
Inclusion
- Age (\>18 years)
- Any type of peripheral blood stem cell transplant (matched-related, match non-related, and haplo)
- Any conditioning regimen
- Newly diagnosed moderate to severe chronic graft versus host disease
- Steroid refractory moderate to severe chronic graft versus host disease defined as progression with prednisone 1mg/kg/day, or stable disease after four to six weeks of prednisone \>0.5 mg/kg/day, or disease progression when reducing prednisone below \<0.5 mg/kg/día.
- 5\. Eastern Cooperative Oncology Group (ECOG) \<= 2
Exclusion
- Disease relapse (excluding positive minimal residual disease)
- Secondary malignancies
- Disease progression
- Use of B lymphocyte cytotoxics in the last month (i.e., rituximab, bortezomib)
- Advance stages of heart failure (NYHA III o IV)
- Ventricular arrhythmias
- Uncontrolled hypertension
- Ischemic heart diseases such as unstable angina or stable angina in the last six months
- Hepatitis B or C
- Hypersensitivity to ibrutinib
- Active bleeding
- Uncontrolled acute infection
- Hepatopathy Child-Pugh C
- Pregnancy
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT05348096
Start Date
April 1 2022
End Date
August 1 2023
Last Update
April 27 2022
Active Locations (1)
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1
Hospital Universitario Dr. José Eleuterio González
Monterrey, Nuevo León, Mexico, 64630