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A Multicenter, Open-Label, Trial to Evaluate the Efficacy and Safety of IDEC-Y2B8 Radioimmunotherapy of Relapsed or Refractory Low-Grade or Follicular Transformed B-Cell Non-Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

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Trial Information

A Multicenter, Open-Label, Trial to Evaluate the Efficacy and Safety of IDEC-Y2B8 Radioimmunotherapy of Relapsed or Refractory Low-Grade or Follicular Transformed B-Cell Non-Hodgkin's Lymphoma


OBJECTIVES: I. Determine the efficacy and safety of rituximab and ibritumomab tiuxetan
radioimmunotherapy in patients with refractory or relapsed, low-grade, follicular, or
transformed B-cell non-Hodgkin's lymphoma.

OUTLINE: This is a multicenter study. Patients receive rituximab IV on days 1 and 8
immediately followed by IDEC-In2B8 IV over 10 minutes on day 1. Patients also receive
ibritumomab tiuxetan IV over 10 minutes on day 8. Patients are followed every 3 months for 2
years and then every 6 months for 2 years.

PROJECTED ACCRUAL: Approximately 400 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven relapsed or refractory, low-grade,
follicular, or transformed B-cell non-Hodgkin's lymphoma (NHL) Prior rituximab allowed if
no response achieved CD20-positive B-cells in lymph nodes or bone marrow required for
small lymphocytic or transformed NHL Less than 25% of bone marrow cellularity in lymphoma
cells No impaired bone marrow reserve, as indicated by one or more of the following: Prior
myeloablative therapy with bone marrow transplantation or peripheral blood stem cell
rescue Platelet count less than 100,000/mm3 Hypocellular bone marrow (no more than 15%
cellularity) Marked reduction in bone marrow precursors of one or more cell lines
(granulocytic, megakaryocytic, or erythroid) History of failed stem cell collection Not
eligible for any active ibritumomab tiuxetan investigative protocols No CNS lymphoma,
AIDS-related lymphoma, or chronic lymphocytic leukemia No pleural effusion 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: 18 and over Performance status: WHO 0-2 Life expectancy: At
least 3 months Hematopoietic: See Disease Characteristics Absolute neutrophil count at
least 1,500/mm3 Lymphocyte count no greater than 5,000/mm3 (for small lymphocytic
lymphoma) Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL
Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception during and for 6 months
after study HIV negative No serious nonmalignant disease or infection that would preclude
study No antimurine antibody reactivity

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 6 weeks
since prior rituximab At least 3 weeks since prior immunotherapy and recovered No prior
radioimmunotherapy At least 2 weeks since prior filgrastim (G-CSF) or sargramostim
(GM-CSF) Chemotherapy: See Disease Characteristics At least 3 weeks since prior
chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered Endocrine therapy: Not
specified Radiotherapy: See Biologic therapy At least 3 weeks since prior radiotherapy and
recovered No prior external beam radiotherapy to more than 25% of active bone marrow
(involved field or regional) Surgery: At least 4 weeks since prior major surgery (other
than diagnostic) and recovered Other: At least 3 weeks since prior anticancer therapy and
recovered At least 8 weeks since prior phase II drugs and recovered No other concurrent
myelosuppressive antineoplastic agents No other concurrent antineoplastic therapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To provide treatment to those patients with low-grade follicular or transformed B-cell non-Hodgkin's lymphoma who are not eligible for other IDEC-Y2B8 protocols.

Outcome Time Frame:

up to 4.25 years

Safety Issue:

No

Principal Investigator

Mansoor N. Saleh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Federal Government

Study ID:

CDR0000067697

NCT ID:

NCT00005592

Start Date:

November 1999

Completion Date:

November 2005

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 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

Name

Location

University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Lombardi Cancer CenterWashington, District of Columbia  20007