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A Phase I/II Study: Zevalin Radioimmunotherapy for Patients With Post Transplant Lymphoproliferative Disease Following Solid Organ Transplantation


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Post-transplant Lymphoproliferative Disorder, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Stage III Adult Burkitt Lymphoma, Stage III Adult Diffuse Large Cell Lymphoma, Stage IV Adult Burkitt Lymphoma, Stage IV Adult Diffuse Large Cell Lymphoma, Waldenström Macroglobulinemia

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Trial Information

A Phase I/II Study: Zevalin Radioimmunotherapy for Patients With Post Transplant Lymphoproliferative Disease Following Solid Organ Transplantation


OBJECTIVES:

I. Determine the safety and tolerability of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8) in
patients with post-transplant lymphoproliferative disorder.

II. Determine the safety and toxicity profile of IDEC-Y2B8 and rituximab in these patients.

III. Correlate the Epstein-Barr virus viral load with response and relapse in patients
treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of yttrium Y 90 ibritumomab tiuxetan
(IDEC-Y2B8).

Phase I: Patients receive rituximab IV and indium In 111 ibritumomab tiuxetan IV over 10
minutes on day 1. Patients undergo 2 (or 3 if needed) imaging scans between days 1-6. In the
absence of altered biodistribution, patients receive rituximab IV followed within 4 hours by
IDEC-Y2B8 IV over 10 minutes on day 8.Cohorts of 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 no more than 1 of 6 patients experience dose-limiting toxicity.

Phase II: Patients receive treatment as in phase I at the MTD of IDEC-Y2B8. Patients are
followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 2
years.


Inclusion Criteria:



- Histologically confirmed post-transplant lymphoproliferative disorder (PTLD) of 1 of
the following stages:

- Stage III or IV

- Localized (not amenable to localized radiotherapy or excision)

- Recurrent

- The following histologies* are eligible:

- Polyclonal PTLD

- Monoclonal PTLD

- Diffuse large B-cell non-Hodgkin's lymphoma (NHL)

- Lymphoplasmacytic NHL

- Burkitt/Burkitt-like NHL

- Must not have completely responded during OR progressed after prior rituximab with or
without chemotherapy

- No history of rapid disease progression while receiving prior chemotherapy

- Measurable disease

- Must have less than 25% bone marrow involvement with lymphoma

- Prior solid organ transplantation required

- Evaluation of malignant cells for Epstein-Barr virus (EBV) required

- EBV positive or negative allowed

- No pleural effusion

- No CNS lymphoma, including leptomeningeal disease

- No pulmonary involvement by NHL in patients with prior lung transplantation

- No HIV or AIDS-related lymphoma

- No hypocellular bone marrow (i.e., less than 15% cellularity)

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

- Performance status - Karnofsky 50-100%

- At least 3 months

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

- Platelet count at least 150,000/mm^3

- Bilirubin no greater than 2.5 mg/dL

- Creatinine no greater than 2.5 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

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

- HIV negative

- No serious nonmalignant disease or infection that would compromise study objectives

- No presence of antimurine antibody reactivity

- No other concurrent active malignancy requiring therapy

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

- More than 6 weeks since prior rituximab

- No prior allogeneic bone marrow or hematopoietic stem cell transplantation

- No prior radioimmunotherapy for NHL

- More than 4 weeks since prior chemotherapy

- See Biologic therapy

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

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

- No other concurrent anticancer 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:

Response rate

Outcome Description:

Estimated using binomial proportions and their 95% confidence intervals.

Outcome Time Frame:

Up to 4 years

Safety Issue:

No

Principal Investigator

David Scadden

Investigator Role:

Principal Investigator

Investigator Affiliation:

AIDS Associated Malignancies Clinical Trials Consortium

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02721

NCT ID:

NCT00064246

Start Date:

July 2003

Completion Date:

Related Keywords:

  • Post-transplant Lymphoproliferative Disorder
  • Recurrent Adult Burkitt Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Stage III Adult Burkitt Lymphoma
  • Stage III Adult Diffuse Large Cell Lymphoma
  • Stage IV Adult Burkitt Lymphoma
  • Stage IV Adult Diffuse Large Cell Lymphoma
  • Waldenström Macroglobulinemia
  • Burkitt Lymphoma
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoproliferative Disorders
  • Waldenstrom Macroglobulinemia

Name

Location

AIDS - Associated Malignancies Clinical Trials ConsortiumRockville, Maryland  20850