Combination Chemotherapy and Rituximab in Treating Patients With Primary Mediastinal Diffuse Large B-Cell Lymphoma

Sponsor
University Hospital Southampton NHS Foundation Trust
Study ID
NCT00689845
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bleomycin sulfate — BIOLOGICAL
    Given IV
  • filgrastim — BIOLOGICAL
    Given subcutaneously
  • rituximab — BIOLOGICAL
    given IV
  • cyclophosphamide — DRUG
    Given IV
  • cytarabine — DRUG
    Given subcutaneously
  • doxorubicin hydrochloride — DRUG
    Given IV
  • etoposide phosphate — DRUG
    Given IV
  • ifosfamide — DRUG
    Given IV
  • methotrexate — DRUG
    Given IV
  • prednisolone — DRUG
    Given orally
  • prednisone — DRUG
    Given orally
  • vincristine sulfate — DRUG
    Given IV
  • vindesine — DRUG
    Given IV

Study Details

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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 or carry cancer-killing substances to them. Giving rituximab together with one of five different combination chemotherapy regimens may kill more cancer cells. PURPOSE: This clinical trial is studying giving rituximab together with combination chemotherapy to see how well it works in treating patients with primary mediastinal diffuse large B-cell lymphoma.

Key Dates

Start date
Jun 30, 2007
Status verified
Jul 2009

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1. Patients also receive oral prednisolone on days 1-5. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Cohort 2
    Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, oral prednisolone on days 1-5, and filgrastim (G-CSF) subcutaneously (SC) on days 5-12. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Cohort 3
    Patients receive rituximab IV on days 1, 22, 43, 64, 85, and 106; cyclophosphamide IV and doxorubicin hydrochloride IV on days 1, 15, 29, 43, 57, and 71; methotrexate IV on days 8, 36, and 64; vincristine IV on days 8, 22, 36, 50 ,64, and 78; bleomycin IV on days 22, 50, and 78; and oral prednisolone on days 1-84, followed by a taper.
  • Experimental: Cohort 4
    Patients receive rituximab IV on days 1, 22, 43, 64, 85, and 106; cyclophosphamide IV on days 1, 29, and 57; doxorubicin hydrochloride IV on days 1, 15, 29, 43, 57, and 71; etoposide phosphate IV on days 15, 16, 43, 44, 71, and 72; vincristine IV and bleomycin IV on days 8, 22, 36, 50, 64, and 78; and oral prednisolone on days 1-84, followed by a taper.
  • Experimental: Cohort 5
    Patients receive rituximab IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1; vindesine IV and bleomycin IV on days 1 and 5; oral prednisone on days 1-5; methotrexate intrathecally on day 2; and G-CSF SC on days 6-13 for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of 4 courses of R-ACVBP, patients receive consolidation therapy comprising high-dose methotrexate IV, rituximab IV, ifosfamide IV, etoposide phosphate IV, and cytarabine SC according to protocol GELA LNH03-2B.

Primary Outcome Measure

Complete response rate on PET scanning at the completion of chemoimmunotherapy

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