Description:
Open-labeled, multicenter, phase I/II study of imatinib combined with ESHAP as salvage
therapy in relapsed/refractory non-Hodgkin's lymphoma
Title
- Brief Title: ESHAP-Imatinib for Refractory/Relapsed Non-Hodgkin's Lymphoma
- Official Title: Open-labeled, Multicenter, Phase I/II Study of Imatinib Combined With ESHAP as Salvage Therapy in Relapsed/Refractory Non-Hodgkin's Lymphoma
Clinical Trial IDs
- ORG STUDY ID:
IMACEL
- NCT ID:
NCT02431403
Conditions
Interventions
Drug | Synonyms | Arms |
---|
ESHAP-Imatinib | | ESHAP-Imatinib 100mg |
Purpose
Open-labeled, multicenter, phase I/II study of imatinib combined with ESHAP as salvage
therapy in relapsed/refractory non-Hodgkin's lymphoma
Trial Arms
Name | Type | Description | Interventions |
---|
ESHAP-Imatinib 100mg | Experimental | 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 | |
ESHAP-Imatinib 200mg | Experimental | 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 | |
ESHAP-Imatinib 400mg | Experimental | 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 | |
ESHAP-Imatinib 300mg | Experimental | 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 | |
Eligibility Criteria
Inclusion Criteria:
1. Histologically diagnosed non-Hodgkin's lymphoma, refractory or relapsed after 1st line
treatment.
2. Paraffin block of the lesions available for immunohistochemical analysis
3. Candidate for ESHAP salvage therapy
4. Evidence of at least one lesion with a diameter of 1.5 cm
5. Age of over 20 years
6. Eastern cooperative oncology group performance status (ECOG) less than or equal to 2.
7. Adequate kidney function with serum creatinine< 2.5 mg/dL, creatinine clearance ≥ 50
mL/min
8. 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.
9. Adequate bone marrow function with absolute neutrophil count ≥ 1,000/uL; platelets ≥
75,000/uL; hemoglobin ≥ 9.0 g/dL
10. Patients who gave voluntarily informed consent before performing any test test that is
not part of routine care of patients
Exclusion Criteria:
1. Patients with history of exposure to imatinib or other Bcr-Abl tyrosine-kinase
inhibitors
2. Known or suspected hypersensitivity to imatinib
3. 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.
4. Known involvement of the central nervous system (CNS) by lymphoma.
5. 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.
6. 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.
7. 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.
8. HIV positive and in treatment.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 20 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of Adverse Events |
Time Frame: | Up to 33 weeks |
Safety Issue: | |
Description: | Adverse events are recorded and analyzed from the time of enrollment to last day of ESHAP-imatinib treatment |
Secondary Outcome Measures
Measure: | Phase I/II Overall Response Rate (ORR) |
Time Frame: | Week 4, Week 10, Week 16 |
Safety Issue: | |
Description: | |
Measure: | Phase II Event-Free Survival |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Phase II Overall Survival |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | Pusan National University Hospital |
Last Updated
May 5, 2015