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Phase 2 Study of Rituximab and ESHAP (Etoposide, Methylprednisolone, Cytarabine, and Cisplatin) in Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma


Phase 2
18 Years
69 Years
Not Enrolling
Both
Lymphoma, Non-Hodgkin

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Trial Information

Phase 2 Study of Rituximab and ESHAP (Etoposide, Methylprednisolone, Cytarabine, and Cisplatin) in Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma


Inclusion Criteria:



- Clinical diagnosis of aggressive non-Hodgkin's lymphoma

- Refractory to the first line chemotherapy or relapsed

- Expression of CD20 on lymphoma cells

- Measurable lesions on imaging studies

Exclusion Criteria:

- Blood cell counts not reaching to 3,000/microliter for white blood cells, 7 g/dl for
hemoglobin, and 50,000/microliter for platelets without transfusion at the time of
registration

- Circulating lymphoma cells equal to or more than 25,000/microliter

- Hepatic dysfunction

- Renal insufficiency

- Cardiac dysfunction or arrhythmia

- Sever infection (bacterial, viral)

- CNS involvement

- Other malignancies

- Pregnancy or breast feeding

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response

Principal Investigator

Norihiro Awaya, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Keio University School of Medicine

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

17-40

NCT ID:

NCT00367497

Start Date:

August 2005

Completion Date:

November 2007

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • aggressive non-Hodgkin's lymphoma
  • salvage chemotherapy
  • rituximab
  • Aggression
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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