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Zevalin And Rituxan For The Treatment Of Relapsed Or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Phase 2
18 Years
Open (Enrolling)

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Trial Information

Zevalin And Rituxan For The Treatment Of Relapsed Or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma


- Determine the best overall response in patients with relapsed or refractory diffuse
large B-cell non-Hodgkin's lymphoma treated with yttrium Y 90 ibritumomab tiuxetan and

- Determine the event-free survival of patients treated with this regimen.

- Determine the toxicity of this regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

- Radioimmunotherapy: Patients receive indium In 111 ibritumomab tiuxetan IV over 10
minutes on day 1 (for imaging only); yttrium Y 90 ibritumomab tiuxetan IV over 10
minutes on day 8; and rituximab IV over 3-4 hours on days 1, 8, 15, 22, 29, and 36.

- CNS prophylaxis: Patients receive CNS prophylaxis comprising intrathecal (IT)
methotrexate or IT cytarabine on days 15, 22, 29, and 36 OR IT cytarabine (liposomal)
on days 15 and 29.

- Maintenance rituximab: Patients are assessed for response at week 14. Beginning at
month 6, patients with stable or responding disease receive maintenance therapy
comprising rituximab IV over 3-4 hours once weekly for 4 weeks. Maintenance therapy
repeats every 6 months for 2 years (total of 4 courses) in the absence of disease
progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.

Inclusion Criteria


- Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma, including any
of the following:

- B-cell diffuse large cell variant

- Immunoblastic

- Mediastinal (thymic) large cell

- T-cell/histiocyte-rich

- Anaplastic large B-cell

- Intravascular large B-cell

- Lymphomatoid granulomatosis

- Relapsed or refractory disease after at least 1 prior chemotherapy regimen and
requires further treatment

- Relapsed disease, defined as the following:

- Appearance of any new lesion OR increase of at least 50% in the size of a
previously involved site

- 50% increase in greatest diameter of any previously identified node greater
than 1 cm in the short axis OR in the sum of the perpendicular diameter
(SPD) of more than 1 node

- Progressive disease, defined as the following:

- 50% increase from nadir in the SPD of any previously identified abnormal

- Appearance of any new lesion during or at the end of therapy

- CD20-positive disease by immunohistochemistry

- Bidimensionally measurable disease

- At least 1 lesion at least 2.0 cm by CT scan

- Less than 25% bone marrow involvement by lymphoma

- No transformed lymphoma from indolent to aggressive

- No HIV- or AIDS-related lymphoma

- No hypocellular bone marrow

- No marked reduction in bone marrow precursors of 1 or more cell lines (e.g.,
granulocytic, megakaryocytic, or erythroid)

- No CNS lymphoma

- Ineligible for myeloablative therapy OR refused transplantation

- Ineligible for any other open yttrium Y 90 ibritumomab tiuxetan investigational



- 18 and over

Performance status

- WHO 0-2

Life expectancy

- At least 3 months


- Absolute neutrophil count at least 1,500/mm^3

- Lymphocyte count no greater than 5,000/mm^3 (for patients with small lymphocytic

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 2.0 mg/dL


- Creatinine no greater than 2.0 mg/dL


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 1 year after study

- No concurrent serious nonmalignant disease or infection that would preclude study

- No human antimurine antibody reactivity


Biologic therapy

- See Disease Characteristics

- No prior autologous bone marrow transplantation

- No prior peripheral blood stem cell rescue

- No prior failed stem cell collection

- Prior rituximab within the past 90 days allowed provided patient has
fludeoxyglucose-avid disease that is also indium In 111 ibritumomab tiuxetan-avid
disease in at least 1 lesion

- More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)


- See Disease Characteristics

Endocrine therapy

- Not specified


- No prior radioimmunotherapy

- No prior external beam radiotherapy (involved field or regional) to more than 25% of
active bone marrow


- More than 4 weeks since prior major surgery (except diagnostic surgery)


- Recovered from all prior therapy

- More than 4 weeks since prior therapy for lymphoma

- More than 8 weeks since prior phase II investigational drugs

- No other concurrent antineoplastic therapy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (complete response, unconfirmed complete response, and partial response) at 12 weeks

Safety Issue:


Principal Investigator

Robin Joyce, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beth Israel Deaconess Medical Center



Study ID:




Start Date:

December 2003

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • anaplastic large cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Fletcher Allen Health Care - Medical Center Campus Burlington, Vermont  05401