Back to resultsESHAP-Imatinib for Refractory/Relapsed Non-Hodgkin's Lymphoma
Primary Purpose
Lymphoma, Non-Hodgkin
Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ESHAP-Imatinib
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Non-Hodgkin
Eligibility Criteria
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 2.
- 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.
Sites / Locations
- Dong-A University HospitalRecruiting
- Inje University Busan Paik HospitalRecruiting
- Kosin University Gospel HospitalRecruiting
- Pusan National University HospitalRecruiting
- Ulsan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
ESHAP-Imatinib 100mg
ESHAP-Imatinib 200mg
ESHAP-Imatinib 400mg
ESHAP-Imatinib 300mg
Arm 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
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
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
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
Outcomes
Primary Outcome Measures
Number of Adverse Events
Adverse events are recorded and analyzed from the time of enrollment to last day of ESHAP-imatinib treatment
Secondary Outcome Measures
Phase I/II Overall Response Rate (ORR)
Phase II Event-Free Survival
Phase II Overall Survival
Full Information
NCT ID
NCT02431403
First Posted
April 21, 2015
Last Updated
May 3, 2015
Sponsor
Pusan National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02431403
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Open-labeled, multicenter, phase I/II study of imatinib combined with ESHAP as salvage therapy in relapsed/refractory non-Hodgkin's lymphoma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
94 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ESHAP-Imatinib 100mg
Arm Type
Experimental
Arm 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
Arm Title
ESHAP-Imatinib 200mg
Arm Type
Experimental
Arm 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
Arm Title
ESHAP-Imatinib 400mg
Arm Type
Experimental
Arm Description
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
Arm Title
ESHAP-Imatinib 300mg
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
ESHAP-Imatinib
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Adverse Events
Description
Adverse events are recorded and analyzed from the time of enrollment to last day of ESHAP-imatinib treatment
Time Frame
Up to 33 weeks
Secondary Outcome Measure Information:
Title
Phase I/II Overall Response Rate (ORR)
Time Frame
Week 4, Week 10, Week 16
Title
Phase II Event-Free Survival
Time Frame
Up to 3 years
Title
Phase II Overall Survival
Time Frame
Up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 2.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyunhee Jung
Phone
+82-51-240-7053
Email
jung77@pnuh.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jooseop Chung
Organizational Affiliation
Pusan National Universty Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dong-A University Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Sook Park
Email
dongahicrc5@naver.com
Facility Name
Inje University Busan Paik Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Hwa Kong
Phone
+82-51-890-6987
Email
velika-jh@nate.com
Facility Name
Kosin University Gospel Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saet Byeol Park
Email
siou7777@naver.com
Facility Name
Pusan National University Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Younghee Kim
Phone
+82-51-240-7899
Email
shinyspring@naver.com
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mi Sun Jeon
Email
uuh3103@naver.com
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ESHAP-Imatinib for Refractory/Relapsed Non-Hodgkin's Lymphoma
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