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A Phase II Study of Yttrium-90-Labeled Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy as First Line Treatment in Indolent Non-Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

A Phase II Study of Yttrium-90-Labeled Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy as First Line Treatment in Indolent Non-Hodgkin's Lymphoma


OBJECTIVES:

Primary

- Determine 12-week overall and complete response rate in patients with indolent
non-Hodgkin's lymphoma treated with rituximab and yttrium Y 90 ibritumomab tiuxetan as
first-line treatment.

Secondary

- Determine 1-year event-free survival of patients treated with this regimen.

- Determine time to progression and time to next antilymphoma therapy in patients treated
with this regimen.

- Determine the molecular response rate in patients treated with this regimen.

- Determine the hematological and non-hematological toxicity of this regimen in these
patients.

- Assess the quality of life of patients treated with this regimen.

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

Patients receive rituximab IV followed, no more than 4 hours later, by indium In 111
ibritumomab tiuxetan (for imaging) IV over 10 minutes on day 1. If biodistribution is
acceptable, patients receive rituximab IV followed, no more than 4 hours later, by a single
dose of yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7, 8, or 9 in the
absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, weeks 6, 10, and 14, every 3 months for 2 years,
and then every 6 months for 2 years.

After completion of study treatment, patients are followed weekly for 3 months, every 3
months for 2 years, and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 18-28 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed indolent non-Hodgkin's lymphoma (NHL), including 1 of the
following histologic subtypes:

- Grade1 or 2 follicular lymphoma

- Small lymphocytic lymphoma (SLL)

- Marginal zone B-cell lymphoma

- CD20-positive disease confirmed by immunohistochemistry or flow cytometry

- Bidimensionally measurable disease

- At least 1 lesion measuring ≥ 2.0 cm in a single dimension by CT scan

- Less than 25% bone marrow involvement with lymphoma by bilateral iliac crest bone
marrow aspiration and biopsy within the past 6 weeks

- No clinically significant impaired bone marrow reserve as evidenced by any of the
following:

- Hypocellular marrow, as evidenced by 1 of the following:

- ≤ 15% cellularity

- Marked reduction in bone marrow precursors

- Platelet count < 100,000/mm^3

- Absolute neutrophil count < 1,500/mm^3

- History of failed stem cell collection

- Prior myeloablative therapy

- No greater than 5,000/mm^3 circulating tumor cells in peripheral blood

- Requires antilymphoma therapy, as indicated by any of the following:

- Systemic symptoms

- B symptoms

- Cytopenias

- Malaise

- Organ compromise

- Discomfort

- Pain

- Disfigurement

- Rapidly progressive disease

- Undue anxiety related to not receiving treatment

- No transformation to intermediate or high-grade NHL

- No known brain metastases or CNS involvement by lymphoma NOTE: A new classification
scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of
"indolent" or "aggressive" lymphoma will replace the former terminology of "low",
"intermediate", or "high" grade lymphoma. However, this protocol uses the former
terminology.

PATIENT CHARACTERISTICS:

Age

- Over 18

Performance status

- ECOG 0-2 OR

- WHO 0-2 OR

- Karnofsky 70-100%

Life expectancy

- More than 3 months

Hematopoietic

- See Disease Characteristics

- WBC ≥ 3,000/mm^3

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Lymphocyte count < 5,000/mm^3 (for patients with SLL )

Hepatic

- Bilirubin ≤ 2.0 mg/dL

- AST and ALT ≤ 2.5 times upper limit of normal

Renal

- Creatinine ≤ 2.0 mg/dL OR

- Creatinine clearance > 60 mL/min

Cardiovascular

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

Immunologic

- No anti-murine antibody reactivity (in patients with prior exposure to murine
antibodies or proteins)

- No ongoing or active infection

- No history of allergic reaction attributed to compounds of similar chemical or
biologic composition to yttrium Y 90 ibritumomab tiuxetan

Other

- Not pregnant or nursing

- Negative pregnancy test

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

- No other active malignancy except non-melanoma skin cancer

- No other serious nonmalignant disease that would preclude study participation

- No psychiatric illness or social situation that would preclude study compliance

- No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 4 weeks since prior pegfilgrastim

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

Chemotherapy

- No prior chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

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

Surgery

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

Other

- No prior systemic antilymphoma therapy

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No other concurrent anticancer therapy

- No other concurrent investigational agents

- No other concurrent antilymphoma therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (complete response, unconfirmed complete response, and partial response) at 14 weeks

Safety Issue:

No

Principal Investigator

Robin Joyce, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

Unspecified

Study ID:

CDR0000409723

NCT ID:

NCT00110149

Start Date:

May 2004

Completion Date:

Related Keywords:

  • Lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • stage I grade 1 follicular lymphoma
  • stage III grade 1 follicular lymphoma
  • stage IV grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • stage I grade 2 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • contiguous stage II marginal zone lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • splenic marginal zone lymphoma
  • stage I marginal zone lymphoma
  • stage III marginal zone lymphoma
  • stage IV marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • contiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • stage I small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage IV small lymphocytic lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075