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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 January 2013 |
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Main ID: |
NCT00058461 |
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Date of registration:
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07/04/2003 |
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Primary sponsor: |
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Public title:
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Combination Chemotherapy and Rituximab in Treating Young Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or Acute Lymphoblastic Leukemia
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Scientific title:
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A Phase II Study of Rituximab (IND#7028) and Ifosfamide, Carboplatin and Etoposide (ICE) Chemotherapy in Children With Recurrent/Refractory B-cell (CD20+) Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia |
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Date of first enrolment:
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February 2003 |
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Target sample size:
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82 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00058461 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Australia
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Canada
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Netherlands
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New Zealand
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Puerto Rico
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Switzerland
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United States
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Contacts
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Name:
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Timothy Griffin |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Oncology Group |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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)
- The following histologies are generally CD20+ and are eligible:
- Diffuse large B-cell lymphoma, mediastinal (thymic) large B-cell lymphoma,
or follicular lymphoma, grade III (rare), documented by flow cytometry or
appropriate immunohistochemistry, any stage
- Burkitt's lymphoma or atypical Burkitt's/Burkitt-like lymphoma, any stage
- B-cell acute lymphoblastic leukemia, with FABL3 morphology and/or
demonstration of surface immunoglobin by flow cytometry
- Atypical precursor B-cell lymphoblastic lymphoma or other unusual
histologies that are CD20+
- 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
- Performance status - ECOG 0-2
- At least 2 months
- Absolute neutrophil count = 1,000/mm^3*
- Platelet count = 100,000/mm^3 (transfusion independent)*
- Hemoglobin = 10.0 g/dL (RBC transfusion allowed)*
- Bilirubin = 1.5 times normal
- ALT < 2.5 times normal
- No chronic renal insufficiency
- Renal insufficiency allowed provided it is secondary to tumor lysis syndrome
- 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
- At least 24 hours since prior growth factor(s)
- At least 60 days since prior biologic (antineoplastic) therapy
- Prior stem cell transplantation allowed provided the following criteria are met:
- 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
- More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for
nitrosoureas)
- No other concurrent chemotherapy
- No concurrent steroids (except for rituximab infusion-related symptoms)
- 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
- Recovered from prior therapy
- No concurrent participation in another phase II study
Age minimum:
N/A
Age maximum:
21 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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B-cell Childhood Acute Lymphoblastic Leukemia
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Childhood Burkitt Lymphoma
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Childhood Diffuse Large Cell Lymphoma
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Childhood Immunoblastic Large Cell Lymphoma
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L3 Childhood Acute Lymphoblastic Leukemia
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Recurrent Childhood Acute Lymphoblastic Leukemia
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Recurrent Childhood Large Cell Lymphoma
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Recurrent Childhood Lymphoblastic Lymphoma
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Recurrent Childhood Small Noncleaved Cell Lymphoma
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Intervention(s)
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Biological: filgrastim
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Biological: rituximab
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Drug: carboplatin
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Drug: cytarabine
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Drug: etoposide
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Drug: ifosfamide
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Drug: methotrexate
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Other: laboratory biomarker analysis
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Primary Outcome(s)
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Relapse-free survival rate
[Time Frame: Up to 3 years]
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Response rate determined by physical exam and appropriate imaging studies
[Time Frame: Up to 3 years]
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Toxicity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
[Time Frame: Up to 3 years]
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Secondary Outcome(s)
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CD34 cells mobilization by flow cytometry
[Time Frame: At the completion of 2 courses of treatment]
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Secondary ID(s)
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ANHL0121
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CDR0000298751
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NCI-2012-01804
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U10CA098543
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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