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Phase I/II Study of IDEC-Y2B8 (Zevalin) for Post Transplant Relapses of B-Cell Non-Hodgkin's Lymphoma

Phase 1/Phase 2
19 Years
Not Enrolling

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Trial Information

Phase I/II Study of IDEC-Y2B8 (Zevalin) for Post Transplant Relapses of B-Cell Non-Hodgkin's Lymphoma


- Determine the maximum tolerated dose of yttrium Y 90-labeled ibritumomab tiuxetan when
administered with rituximab in patients with B-cell non-Hodgkin's lymphoma who have
relapsed after high-dose chemotherapy and autologous hematopoietic stem cell

- Determine the safety and efficacy of this regimen in these patients.

OUTLINE: This is a dose-escalation study of yttrium Y 90-labeled ibritumomab tiuxetan

- Phase I: Patients receive rituximab IV over 4-6 hours followed by indium In 111-labeled
ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 0. Patients receive
rituximab IV again on day 7 followed by IDEC-Y2B8 IV over 10 minutes.

Cohorts of 3-6 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which 3 of 6 patients experience
dose-limiting toxicity.

- Phase II: Once the MTD is determined, 58 additional patients are treated at that dose
level as in phase I.

Patients are followed at 6 weeks, every 3 months for 1 year, every 6 months for 2 years, and
then annually thereafter.

PROJECTED ACCRUAL: Approximately 78 patients (20 for phase I and 58 for phase II) will be
accrued for this study within 2 years.

Inclusion Criteria


- Diagnosis of relapsed B-cell non-Hodgkin's lymphoma (NHL) after high-dose
chemotherapy and autologous stem cell transplantation

- Less than 25% bone marrow involvement with NHL as evidenced by unilateral or
bilateral biopsy within the past 6 weeks

- Bone marrow biopsy should demonstrate 15-20% of cellular space occupied by
normal hematopoiesis

- CD20 antigen expression in tumor tissue within the past year as evidenced by 1 of the

- Immunoperoxidase stains of tissue showing positive reactivity with L26 antibody

- Flow cytometry studies

- Measurable disease

- More than 2 cm bidimensionally

- No active CNS lymphoma

- No HIV- or AIDS-related lymphoma



- 19 and over

Performance status:

- WHO 0-2

Life expectancy:

- At least 3 months


- Absolute neutrophil count greater than 1,500/mm^3

- Platelet count greater than 150,000/mm^3

- No transfusion dependency


- Bilirubin less than 2.0 mg/dL

- SGOT or SGPT no greater than 2.5 times upper limit of normal (unless due to
lymphomatous infiltration of the liver)


- Creatinine less than 2.0 mg/dL

- No active obstructive hydronephrosis


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study

- HIV negative

- No active infection requiring oral or IV antibiotics

- No human antimurine antibody positivity

- No other major medical problems


Biologic therapy:

- See Disease Characteristics

- At least 4 weeks since prior growth factors

- At least 4 weeks since prior biologic therapy

- No dependency on hematopoietic growth factors (e.g., epoetin alfa, interleukin-11,
filgrastim [G-CSF], or sargramostim [GM-CSF])

- No prior radioimmunotherapy

- No other concurrent biologic therapy of any kind


- See Disease Characteristics

- At least 4 weeks since any prior cytotoxic chemotherapy (6 weeks for nitrosoureas)

- No prior fludarabine

- No concurrent chemotherapy

Endocrine therapy:

- No concurrent steroids except as maintenance for non-cancerous disease


- See Biologic therapy

- At least 4 weeks since prior radiotherapy

- No prior pelvic radiotherapy

- No prior radiotherapy to more than 25% of estimated bone marrow reserve

- No concurrent external beam radiotherapy


- Not specified


- Recovered from all prior therapy

- At least 4 weeks since prior immunosuppressants

- No other concurrent investigational drugs

- No other concurrent anti-cancer therapy

Type of Study:


Study Design:

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

Outcome Measure:

Maximum tolerated dose

Safety Issue:


Principal Investigator

Julie M. Vose, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Nebraska


United States: Food and Drug Administration

Study ID:




Start Date:

January 2002

Completion Date:

March 2008

Related Keywords:

  • Lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell



UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha, Nebraska  68198-7680