Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma

Conditions

• Childhood Burkitt Lymphoma
• Childhood Diffuse Large Cell Lymphoma
• Childhood Immunoblastic Large Cell Lymphoma
• Stage I Childhood Large Cell Lymphoma
• Stage I Childhood Small Noncleaved Cell Lymphoma
• Stage II Childhood Large Cell Lymphoma
• Stage II Childhood Small Noncleaved Cell Lymphoma
• Stage III Childhood Large Cell Lymphoma
• Stage III Childhood Small Noncleaved Cell Lymphoma
• Stage IV Childhood Large Cell Lymphoma
• Stage IV Childhood Small Noncleaved Cell Lymphoma
• Untreated Childhood Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex

ALL

Age

1 Year - 29 Years

Healthy Volunteers

Not accepted

Interventions

• doxorubicin hydrochloride — DRUG
  Given IV, IT, or orally
• cyclophosphamide — DRUG
  Given IV
• methotrexate — DRUG
  Given IV or IT
• rasburicase — DRUG
  Given IV
• leucovorin calcium — DRUG
  Given IV or orally
• prednisone — DRUG
  Given IV or orally
• methylprednisolone — DRUG
  Given IV or orally
• filgrastim — BIOLOGICAL
  Given subcutaneously
• rituximab — BIOLOGICAL
  Given IV
• cytarabine — DRUG
  Given IT
• etoposide — DRUG
  Given IV
• vincristine sulfate — DRUG
  Given IV
• hydrocortisone sodium succinate — DRUG
  Given IT
• laboratory biomarker analysis — OTHER
  Correlative studies

Study Details

Phase II trial to study the effectiveness of combining rituximab and rasburicase with combination chemotherapy in treating young patients who have newly diagnosed advanced B-cell leukemia or lymphoma. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug with rituximab may kill more cancer cells. Chemoprotective drugs such as rasburicase may protect kidney cells from the side effects of chemotherapy.

Key Dates

Start date

Jun 30, 2004

Status verified

Sep 2014

Primary completion

Oct 31, 2009

Completion

Jul 31, 2014

Study Design

Enrollment

97 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group B (chemotherapy, protective therapy, monoclonal antib.)
  Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
• Experimental: Group C (Chemotherapy, monoclonal antibody therapy)
  Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.

Primary Outcome Measure

Grade ≥ 3 Stomatitis [ Time Frame: Up to 1 year ]

Locations (1)

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