Clinical trial · Interventional
ESHAP-Imatinib for Refractory/Relapsed Non-Hodgkin's Lymphoma
Open-labeled, Multicenter, Phase I/II Study of Imatinib Combined With ESHAP as Salvage Therapy in Relapsed/Refractory Non-Hodgkin's Lymphoma
NCT02431403CI-TRIAL-00017784unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Open-labeled, multicenter, phase I/II study of imatinib combined with ESHAP as salvage therapy in relapsed/refractory non-Hodgkin's lymphoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ESHAP-Imatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- ESHAP-Imatinib 100mg
- description
- 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
- interventionNames
- Drug: ESHAP-Imatinib
- type
- EXPERIMENTAL
- label
- ESHAP-Imatinib 200mg
- description
- 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
- interventionNames
- Drug: ESHAP-Imatinib
- type
- EXPERIMENTAL
- label
- ESHAP-Imatinib 400mg
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (29)
- BACKGROUNDEdling CE, Hallberg B. c-Kit--a hematopoietic cell essential receptor tyrosine kinase. Int J Biochem Cell Biol. 2007;39(11):1995-8. doi: 10.1016/j.biocel.2006.12.005. Epub 2007 Jan 20. PMID 17350321
- BACKGROUNDEscribano L, Ocqueteau M, Almeida J, Orfao A, San Miguel JF. Expression of the c-kit (CD117) molecule in normal and malignant hematopoiesis. Leuk Lymphoma. 1998 Aug;30(5-6):459-66. doi: 10.3109/10428199809057558. PMID 9711908
- BACKGROUNDIkeda H, Kanakura Y, Tamaki T, Kuriu A, Kitayama H, Ishikawa J, Kanayama Y, Yonezawa T, Tarui S, Griffin JD. Expression and functional role of the proto-oncogene c-kit in acute myeloblastic leukemia cells. Blood. 1991 Dec 1;78(11):2962-8. PMID 1720040
- BACKGROUNDPinto A, Gloghini A, Gattei V, Aldinucci D, Zagonel V, Carbone A. Expression of the c-kit receptor in human lymphomas is restricted to Hodgkin's disease and CD30+ anaplastic large cell lymphomas. Blood. 1994 Feb 1;83(3):785-92. PMID 7507733
- BACKGROUNDHongyo T, Li T, Syaifudin M, Baskar R, Ikeda H, Kanakura Y, Aozasa K, Nomura T. Specific c-kit mutations in sinonasal natural killer/T-cell lymphoma in China and Japan. Cancer Res. 2000 May 1;60(9):2345-7. PMID 10811105
- BACKGROUNDMelnyk A, Rodriguez A, Pugh WC, Cabannillas F. Evaluation of the Revised European-American Lymphoma classification confirms the clinical relevance of immunophenotype in 560 cases of aggressive non-Hodgkin's lymphoma. Blood. 1997 Jun 15;89(12):4514-20. PMID 9192775
- BACKGROUNDAozasa K, Zaki MA. Epidemiology and pathogenesis of nasal NK/T-cell lymphoma: a mini-review. ScientificWorldJournal. 2011 Feb 14;11:422-8. doi: 10.1100/tsw.2011.41. PMID 21336457
- Brauns TC, Schultewolter T, Dissemond J, Maschke J, Goos M. C-KIT expression in primary cutaneous T-cell lymphomas. J Cutan Pathol. 2004 Oct;31(9):577-82. doi: 10.1111/j.0303-6987.2004.00182.x.