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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


Phase 2
N/A
21 Years
Not Enrolling
Both
B-cell Childhood Acute Lymphoblastic Leukemia, Childhood Burkitt Lymphoma, Childhood Diffuse Large Cell Lymphoma, Childhood Immunoblastic Large Cell Lymphoma, L3 Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Small Noncleaved Cell Lymphoma

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Trial Information

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


PRIMARY OBJECTIVES:

I. Determine the response of pediatric patients with relapsed or refractory B-cell
non-Hodgkin's lymphoma or acute lymphoblastic leukemia treated with ifosfamide, carboplatin,
and etoposide combined with rituximab.

II. Determine the relapse-free survival rate of patients treated with this regimen.

III. Determine the toxicity profile of this regimen in these patients, specifically the
frequency of therapy delays between courses due to prolonged grade IV hematologic toxicity.

SECONDARY OBJECTIVES:

I. Determine whether this regimen plus filgrastim (G-CSF) will result in mobilization of
greater than 2 X 10^6/kg peripheral blood stem cells (CD34+ cells, PBSC) in at least 80% of
patients for whom peripheral stem cell collection is performed.

II. Determine the time course of engraftment for patients who undergo peripheral stem cell
transplantation after collection of stem cells using this mobilization regimen.

OUTLINE: This is a multicenter study. Patients are stratified by disease (B-cell large cell
lymphoma or atypical precursor B-cell lymphoblastic lymphoma vs small non-cleaved cell
lymphoma or B-cell acute lymphoblastic leukemia).

Patients receive ifosfamide IV over 2 hours and etoposide IV over 1 hour on days 3-5,
rituximab IV on days 1 and 3, and carboplatin IV over 1 hour on day 3. Patients receive
filgrastim (G-CSF) subcutaneously once daily beginning on day 6 and continuing until blood
counts recover. Patients also receive intrathecal (IT) chemotherapy comprising methotrexate
and cytarabine. Patients with B-cell large cell lymphoma and negative CSF cytology receive
IT chemotherapy on day 3 of the first course only. Patients with small non-cleaved cell
lymphoma or B-cell acute lymphoblastic leukemia and negative CSF cytology receive IT
chemotherapy on day 3. All patients with positive CSF cytology receive IT chemotherapy on
days 3, 10, and 17 of the first and second courses. Treatment repeats every 23 days for up
to 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 42-82 patients (21-41 per disease stratum) will be accrued for
this study within 2-4 years.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate determined by physical exam and appropriate imaging studies

Outcome Description:

Response rates and confidence intervals will be constructed according to the method of Chang and O'Brien.

Outcome Time Frame:

Up to 3 years

Safety Issue:

No

Principal Investigator

Timothy Griffin

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01804

NCT ID:

NCT00058461

Start Date:

February 2003

Completion Date:

Related Keywords:

  • B-cell Childhood Acute Lymphoblastic Leukemia
  • Childhood Burkitt Lymphoma
  • Childhood Diffuse Large Cell Lymphoma
  • Childhood Immunoblastic Large Cell Lymphoma
  • L3 Childhood Acute Lymphoblastic Leukemia
  • Recurrent Childhood Acute Lymphoblastic Leukemia
  • Recurrent Childhood Large Cell Lymphoma
  • Recurrent Childhood Lymphoblastic Lymphoma
  • Recurrent Childhood Small Noncleaved Cell Lymphoma
  • Burkitt Lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Children's Oncology GroupArcadia, California  91006-3776