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

May 3, 2015 updated by: Jooseop Chung, Pusan National University Hospital

Open-labeled, Multicenter, Phase I/II Study of Imatinib Combined With ESHAP as Salvage Therapy in Relapsed/Refractory 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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

94

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Recruiting
        • Pusan National University Hospital
        • Contact:
      • Busan, Korea, Republic of
        • Recruiting
        • Inje University Busan Paik Hospital
        • Contact:
      • Busan, Korea, Republic of
      • Busan, Korea, Republic of
        • Recruiting
        • Kosin University Gospel Hospital
        • Contact:
      • Ulsan, Korea, Republic of

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Adverse Events
Time Frame: Up to 33 weeks
Adverse events are recorded and analyzed from the time of enrollment to last day of ESHAP-imatinib treatment
Up to 33 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Phase I/II Overall Response Rate (ORR)
Time Frame: Week 4, Week 10, Week 16
Week 4, Week 10, Week 16
Phase II Event-Free Survival
Time Frame: Up to 3 years
Up to 3 years
Phase II Overall Survival
Time Frame: Up to 3 years
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Hospital

Investigators

  • Principal Investigator: Jooseop Chung, Pusan National Universty Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

April 21, 2015

First Submitted That Met QC Criteria

April 27, 2015

First Posted (Estimate)

May 1, 2015

Study Record Updates

Last Update Posted (Estimate)

May 5, 2015

Last Update Submitted That Met QC Criteria

May 3, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMACEL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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