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Status:

COMPLETED

Rituximab and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Lead Sponsor:

Eastern Cooperative Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Lymphoma

Eligibility:

All Genders

18-70 years

Phase:

PHASE2

Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them o...

Detailed Description

OBJECTIVES: Primary * Determine the 2-year progression-free survival (PFS) rate after treatment with rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in patients with bulky stage II or stag...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • Diffuse large B-cell non-Hodgkin's lymphoma
  • Bulky stage II (bulk defined as any lesion ≥ 10 cm) or stage III or IV disease
  • The following lymphoma types are excluded:
  • Primary central nervous system lymphoma
  • Transformed low-grade lymphoma (prior history of low-grade lymphoma or clear presence of low-grade lymphoma on histologic sections)
  • Primary mediastinal B-cell lymphoma or testicular lymphoma (consolidative radiotherapy is usually indicated)
  • Immunodeficiency-related lymphoma (i.e., after organ or bone marrow transplant)
  • Measurable disease
  • Patient must have at least one objective measurable disease site (i.e., measurable in at least 2 perpendicular parameters)
  • Measurable disease in the liver is required if the liver is the only site of lymphoma involvement
  • Abnormal positron emission tomography scans will not constitute evaluable disease, unless verified by CT scan or other appropriate imaging
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-3
  • For patients \> 50 years of age, a normal ejection fraction by ECHO or Multigated Acquisition Scan (MUGA) is required within 6 weeks prior to registration
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count \> 100,000/mm\^3
  • Creatinine \< 2.0 mg/dL
  • Bilirubin \< 2 mg/dL (may be up to 3.0 mg/dL if due to liver involvement by lymphoma)
  • EXCLUSION CRITERIA:
  • Prior chemotherapy or radiation therapy for lymphoma
  • Prior anthracyclines or platinum compounds used as systemic chemotherapy
  • Prior radiation therapy to the mediastinum or to ≥ 25% of the bone marrow
  • Concurrent pentostatin or trastuzumab (Herceptin®)
  • Pregnant or nursing
  • Prior malignancy within the past 5 years unless it was in situ OR was treated with curative intent AND the patient has remained relapse-free
  • HIV positive

Exclusion

    Key Trial Info

    Start Date :

    September 26 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2019

    Estimated Enrollment :

    100 Patients enrolled

    Trial Details

    Trial ID

    NCT00274924

    Start Date

    September 26 2006

    End Date

    March 1 2019

    Last Update

    June 29 2023

    Active Locations (104)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 26 (104 locations)

    1

    Veterans Affairs Medical Center - Palo Alto

    Palo Alto, California, United States, 94304

    2

    Front Range Cancer Specialists

    Fort Collins, Colorado, United States, 80528

    3

    Baptist Cancer Institute - Jacksonville

    Jacksonville, Florida, United States, 32207

    4

    Mayo Clinic - Jacksonville

    Jacksonville, Florida, United States, 32224