ESHAP-Imatinib for Refractory/Relapsed Non-Hodgkin's Lymphoma
NCT ID: NCT02431403
Last Updated: 2015-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
94 participants
INTERVENTIONAL
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
ESHAP-Imatinib
After selection of the maximum-tolerated dose of the combination ESHAP with imatinib a phase 2 of the study will be performed in order to evaluate the ORR of ESHAP-imatinib.
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
ESHAP-Imatinib
After selection of the maximum-tolerated dose of the combination ESHAP with imatinib a phase 2 of the study will be performed in order to evaluate the ORR of ESHAP-imatinib.
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
ESHAP-Imatinib
After selection of the maximum-tolerated dose of the combination ESHAP with imatinib a phase 2 of the study will be performed in order to evaluate the ORR of ESHAP-imatinib.
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
ESHAP-Imatinib
After selection of the maximum-tolerated dose of the combination ESHAP with imatinib a phase 2 of the study will be performed in order to evaluate the ORR of ESHAP-imatinib.
Interventions
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ESHAP-Imatinib
After selection of the maximum-tolerated dose of the combination ESHAP with imatinib a phase 2 of the study will be performed in order to evaluate the ORR of ESHAP-imatinib.
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
ALL
No
Sponsors
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Pusan National University Hospital
OTHER
Responsible Party
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Jooseop Chung
Professor department of hematooncology
Principal Investigators
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Jooseop Chung
Role: PRINCIPAL_INVESTIGATOR
Pusan National Universty Hospital
Locations
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Dong-A University Hospital
Busan, , South Korea
Inje University Busan Paik Hospital
Busan, , South Korea
Kosin University Gospel Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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IMACEL
Identifier Type: -
Identifier Source: org_study_id
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