Combination Chemotherapy and Rituximab in Treating Young Patients With Recurrent or Refractory Non-Hodgkin’s Lymphoma or Acute Lymphoblastic Leukemia

This phase II trial is studying how well rituximab together with ifosfamide, carboplatin, and etoposide works in treating young patients with recurrent or refractory non-Hodgkin’s lymphoma or acute lymphoblastic leukemia

Official Title

A Phase II Study Of Rituximab And ICE Chemotherapy In Children With Recurrent/Refractory B-Cell (CD20+) Non-Hodgkin Lymphoma And B-Cell Acute Lymphoblastic Leukemia

Conditions

• Acute Lymphoblastic Leukemia
• Non-Hodgkin’s Lymphoma

Study Type

Interventional

Study Design

Treatment, Open Label

Further Details

Primary Outcome Measures:

• Response
• Relapse-free survival rate
• Toxicity
• Mobilization
• Time course of engraftment

Study Start

November 2003

Eligibility & Criteria

• Ages Eligible for Study: up to 21 Years
• Genders Eligible for Study: Both

Inclusion Criteria:

• DISEASE CHARACTERISTICS:
  • Histologically confirmed B-cell non-Hodgkin’s lymphoma OR acute lymphoblastic leukemia
    • CD20+ (confirmed by flow cytometry of tumor tissue, involved marrow, or CD20 immunostaining)
  • Measurable disease by clinical, radiographic, or histologic criteria
  • Must be in first or later recurrence or have disease that is primarily refractory to conventional therapy
  • No isolated CNS disease
• PATIENT CHARACTERISTICS:
  • Age: 21 or under when diagnosed with recurrent or refractory disease
  • Performance status: ECOG 0-2
  • Life expectancy: At least 2 months
  • Hematopoietic:
    • Absolute neutrophil count > 1,000/mm³
    • Platelet count > 100,000/mm³ (transfusion independent)
    • Hemoglobin > 10.0 g/dL (RBC transfusion allowed)

    NOTE: Patients with B-cell acute lymphoblastic leukemia and lymphoma involving bone marrow who have granulocytopenia, anemia, and/or thrombocytopenia are eligible but are not evaluable for hematologic toxicity

  • Hepatic:
    • Bilirubin < 1.5 times normal
    • ALT < 2.5 times normal
  • Renal: No chronic renal insufficiency (Renal insufficiency allowed provided it is secondary to tumor lysis syndrome)
  • Other:
    • Not pregnant or nursing
    • Negative pregnancy test
    • Fertile patients must use effective contraception during and for 3 months after study treatment
    • HIV negative
    • No active uncontrolled infection
    • Seizure disorder allowed if well controlled with anticonvulsants
    • No CNS toxicity greater than grade II
• PRIOR CONCURRENT THERAPY:
  • Biologic therapy:
    • At least 24 hours since prior growth factor(s)
    • At least 60 days since prior biologic (antineoplastic) therapy
    • Prior stem cell transplantation allowed provided: More than 60 days since transplantation; Hematopoietic lab value requirements are met (See Hematopoietic); No evidence of graft-versus-host disease (if post-allogeneic transplantation) Prior monoclonal antibody therapy allowed (including rituximab)
    • No other concurrent immunomodulating agents
  • Chemotherapy:
    • More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas)
    • No other concurrent chemotherapy
  • Endocrine therapy: No concurrent steroids (except for rituximab infusion-related symptoms)
  • Radiotherapy:
    • At least 2 weeks since prior local palliative radiotherapy (small port)
    • At least 6 weeks since prior substantial bone marrow radiotherapy
    • At least 6 months since prior craniospinal radiotherapy or radiotherapy to 50% or more of the pelvis
    • Concurrent radiotherapy to localized painful, airway-compromising, or other acute organ-threatening lesions allowed provided at least 1 measurable lesion is not irradiated
  • Other:
    • Recovered from prior therapy
    • No concurrent participation in another phase II study

Total Enrolment

42-82

Contact Details

• Prince of Wales Private Hospital, Randwick, New South Wales, 2031, Australia
• Royal Children’s Hospital, Herston, Brisbane, Queensland, 4029, Australia
• Women’s and Children’s Hospital, North Adelaide, South Australia, 5006, Australia
• Princess Margaret Hospital for Children, Perth, Western Australia, 6001, Australia

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