Open-labeled, Multicenter, Phase I/II Study of Imatinib Combined With ESHAP as Salvage Therapy in Relapsed/Refractory Non-Hodgkin's Lymphoma
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 94
- Locations
- 5
- Primary Endpoint
- Number of Adverse Events
Study Overview
Brief Summary
Open-labeled, multicenter, phase I/II study of imatinib combined with ESHAP as salvage therapy in relapsed/refractory non-Hodgkin's lymphoma
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically diagnosed non-Hodgkin's lymphoma, refractory or relapsed after 1st line treatment.
- •Paraffin block of the lesions available for immunohistochemical analysis
- •Candidate for ESHAP salvage therapy
- •Evidence of at least one lesion with a diameter of 1.5 cm
- •Age of over 20 years
- •Eastern cooperative oncology group performance status (ECOG) less than or equal to
- •Adequate kidney function with serum creatinine< 2.5 mg/dL, creatinine clearance ≥ 50 mL/min
- •Adequate liver function with aspartate transaminase (AST)/alanine aminotransferase (ALT) lower than or equal to 3 times the normal upper limit; Total bilirubin lower than or equal to 1.5 times the upper limit ;alkaline phosphatase lower than or equal to 5 times the normal upper limit.
- •Adequate bone marrow function with absolute neutrophil count ≥ 1,000/uL; platelets ≥ 75,000/uL; hemoglobin ≥ 9.0 g/dL
- •Patients who gave voluntarily informed consent before performing any test test that is not part of routine care of patients
Exclusion Criteria
- •Patients with history of exposure to imatinib or other Bcr-Abl tyrosine-kinase inhibitors
- •Known or suspected hypersensitivity to imatinib
- •Potential use or usage alteration of CYP3A4 inducers or inhibitors from prior to 21 days of to the test regimen until the initiation of round 2 ESHAP. Exceptions are itraconazole and fluconazole for treatment or prevention of fungal infection, hydrocortisone and dexamethasone for treatment of nausea/vomiting/fluid retention, and methylprednisolone as a part of the ESHAP regimen.
- •Known involvement of the central nervous system (CNS) by lymphoma.
- •Pregnant or breast-feeding. Females of childbearing potential who do not agree to undergo pregnancy tests or repeated use effective birth control while included in the clinical trial.
- •Serious or uncontrolled medical condition, such as presence of abnormal or clinically significant cardiac disease, such as acute myocardial infarction or unstable angina within 6 months prior to initiation of treatment with ESHAP-imatinib, serious neurological or psychological conditions such as dementia or epilepsy, or uncontrolled active infection.
- •Prior history of malignancy other than to non-Hodgkin's lymphoma (except basal or squamous cell skin and in situ carcinoma of the cervix) unless the patient free of disease beyond 5 years are.
- •HIV positive and in treatment.
Arms & Interventions
ESHAP-Imatinib 100mg
Imatinib 100 mg combined with ESHAP
* ESAHP D1-4 Etoposide 40mg/m2 D1-4 Cisplatin 25mg/m2 D5 Cytarabine 2000mg/m2 D1-5 Methylprednisolone 250mg/m2 D6 Pegfilgrastim 6mg
Intervention: ESHAP-Imatinib (Drug)
ESHAP-Imatinib 200mg
Imatinib 200 mg combined with ESHAP
* ESAHP D1-4 Etoposide 40mg/m2 D1-4 Cisplatin 25mg/m2 D5 Cytarabine 2000mg/m2 D1-5 Methylprednisolone 250mg/m2 D6 Pegfilgrastim 6mg
Intervention: ESHAP-Imatinib (Drug)
ESHAP-Imatinib 400mg
Imatinib 400 mg combined with ESHAP
* ESAHP D1-4 Etoposide 40mg/m2 D1-4 Cisplatin 25mg/m2 D5 Cytarabine 2000mg/m2 D1-5 Methylprednisolone 250mg/m2 D6 Pegfilgrastim 6mg
Intervention: ESHAP-Imatinib (Drug)
ESHAP-Imatinib 300mg
Imatinib 300 mg combined with ESHAP
* ESAHP D1-4 Etoposide 40mg/m2 D1-4 Cisplatin 25mg/m2 D5 Cytarabine 2000mg/m2 D1-5 Methylprednisolone 250mg/m2 D6 Pegfilgrastim 6mg
Intervention: ESHAP-Imatinib (Drug)
Outcomes
Primary Outcomes
Number of Adverse Events
Time Frame: Up to 33 weeks
Adverse events are recorded and analyzed from the time of enrollment to last day of ESHAP-imatinib treatment
Secondary Outcomes
- Phase II Event-Free Survival(Up to 3 years)
- Phase II Overall Survival(Up to 3 years)
- Phase I/II Overall Response Rate (ORR)(Week 4, Week 10, Week 16)
Investigators
Jooseop Chung
Professor department of hematooncology
Pusan National University Hospital