Monoclonal Antibody Therapy in Relapsed Non-Hodgkin's After Chemotherapy and Autologous Stem Cell Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-01

Study Completion Date

2008-03-01

Brief Summary

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RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and deliver cancer-killing substances to them without harming normal cells. Radiolabeled monoclonal antibodies can locate and deliver radioactive cancer-killing substances.

PURPOSE: Phase I/II trial to study the effectiveness of combining radiolabeled monoclonal antibodies with rituximab in treating patients who have non-Hodgkin's lymphoma that has not responded to high-dose chemotherapy and autologous stem cell transplantation.

Detailed Description

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OBJECTIVES:

* 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 transplantation.
* 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 (IDEC-Y2B8).

* 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.

Conditions

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Lymphoma

Keywords

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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rituximab

Intervention Type BIOLOGICAL

yttrium Y 90 ibritumomab tiuxetan

Intervention Type RADIATION

Eligibility Criteria

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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

o 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 following:

* Immunoperoxidase stains of tissue showing positive reactivity with L26 antibody
* Flow cytometry studies
* Measurable disease

o More than 2 cm bidimensionally
* 19 years of age 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
* 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
* Fertile patients must use effective contraception during and for 6 months after study therapy
* HIV negative
* At least 4 weeks since prior growth factors
* At least 4 weeks since prior biologic therapy
* At least 4 weeks since any prior cytotoxic chemotherapy (6 weeks for nitrosoureas)
* At least 4 weeks since prior radiotherapy
* Recovered from all prior therapy
* At least 4 weeks since prior immunosuppressants

Exclusion Criteria

* No active CNS lymphoma
* No HIV- or AIDS-related lymphoma
* No transfusion dependency
* No active obstructive hydronephrosis
* Not pregnant or nursing/negative pregnancy test
* No active infection requiring oral or IV antibiotics
* No human antimurine antibody positivity
* No other major medical problems
* 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
* No prior fludarabine
* No concurrent chemotherapy
* No concurrent steroids except as maintenance for non-cancerous disease
* No prior pelvic radiotherapy
* No prior radiotherapy to more than 25% of estimated bone marrow reserve
* No concurrent external beam radiotherapy
* No other concurrent investigational drugs
* No other concurrent anti-cancer therapy

Minimum Eligible Age

19 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julie M Vose, MD

Role: STUDY_CHAIR

University of Nebraska

Locations

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Eppley Cancer Center at University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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CDR0000069211

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-V02-1691

Identifier Type: OTHER_GRANT