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

NCT02431403 | Unknown Phase 1

• 1 other identifier: IMACEL
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 5

Brief Summary

Open-labeled, multicenter, phase I/II study of imatinib combined with ESHAP as salvage therapy in relapsed/refractory non-Hodgkin's lymphoma

Conditions

Lymphoma, Non-Hodgkin

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

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

  Up to 33 weeks

Secondary Outcomes (3)

• Phase I/II Overall Response Rate (ORR)

  Week 4, Week 10, Week 16

• Phase II Event-Free Survival

  Up to 3 years

• Phase II Overall Survival

  Up to 3 years

Study Arms (4)

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

Drug: ESHAP-Imatinib

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

Drug: ESHAP-Imatinib

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

Drug: ESHAP-Imatinib

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

Drug: ESHAP-Imatinib

Interventions

ESHAP-Imatinib DRUG

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; ESHAP-Imatinib 200mg; ESHAP-Imatinib 300mg; ESHAP-Imatinib 400mg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (5)

Dong-A University Hospital

Busan, South Korea

RECRUITING

Inje University Busan Paik Hospital

Busan, South Korea

RECRUITING

Kosin University Gospel Hospital

Busan, South Korea

RECRUITING

Pusan National University Hospital

Busan, South Korea

RECRUITING

Ulsan University Hospital

Ulsan, South Korea

RECRUITING

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MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jooseop Chung

  Pusan National Universty Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyunhee Jung

CONTACT

+82-51-240-7053; jung77@pnuh.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor department of hematooncology

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: May 1, 2015
• Study Start: February 1, 2015
• Primary Completion: February 1, 2020
• Last Updated: May 5, 2015

Record last verified: 2015-05

Locations

KR (5)