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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