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ESHAP-Imatinib for Refractory/Relapsed Non-Hodgkin's Lymphoma

Sponsor
Pusan National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02431403
Collaborator
(none)
94
Enrollment
5
Locations
4
Arms
18.8
Patients Per Site

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
94 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Feb 1, 2015
Anticipated Primary Completion Date :
Feb 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Drug: 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.
Experimental: 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

Drug: 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.
Experimental: 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

Drug: 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.
Experimental: 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

Drug: 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.

Outcome Measures

Primary Outcome Measures

  1. Number of Adverse Events [Up to 33 weeks]

    Adverse events are recorded and analyzed from the time of enrollment to last day of ESHAP-imatinib treatment

Secondary Outcome Measures

  1. Phase I/II Overall Response Rate (ORR) [Week 4, Week 10, Week 16]

  2. Phase II Event-Free Survival [Up to 3 years]

  3. Phase II Overall Survival [Up to 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dong-A University Hospital Busan Korea, Republic of
2 Inje University Busan Paik Hospital Busan Korea, Republic of
3 Kosin University Gospel Hospital Busan Korea, Republic of
4 Pusan National University Hospital Busan Korea, Republic of
5 Ulsan University Hospital Ulsan Korea, Republic of

Sponsors and Collaborators

  • Pusan National University Hospital

Investigators

  • Principal Investigator: Jooseop Chung, Pusan National Universty Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jooseop Chung, Professor department of hematooncology, Pusan National University Hospital
ClinicalTrials.gov Identifier:
NCT02431403
Other Study ID Numbers:
  • IMACEL
First Posted:
May 1, 2015
Last Update Posted:
May 5, 2015
Last Verified:
May 1, 2015
Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Imatinib Mesylate

Study Results

No Results Posted as of May 5, 2015