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Tositumomab And Iodine I 131-Tositumomab In Patients With Relapsed Indolent Non-Hodgkin's Lymphoma

NCT ID: NCT00240565

Last Updated: 2012-08-13

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

PHASE2

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2011-09-30

Brief Summary

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This study will further characterize the activity of Tositumomab and Iodine I 131-Tositumomab in patients with relapsed indolent non-Hodgkin's Lymphoma who have progressed following treatment with rituximab.

Detailed Description

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Conditions

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Lymphoma, Non-Hodgkin

Keywords

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BEXXAR non-Hodgkin's Lymphoma tositumomab I-131

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Participants underwent two phases of treatment: an initial DD, followed by a therapeutic dose. The one-day DD comprised a 1 hr IV infusion of 450 mg unlabeled TST, followed by a 20 min IV infusion of 35 mg TST labeled with 185 MBq (5.0 mCi) of I 131. After 7 to 14 days, the one-day therapeutic dose comprised a second 1 hr IV infusion of 450 mg unlabeled TST, followed by a 20 min IV infusion of 35 mg TST labeled with I 131 with an administered activity (MBq or mCi) determined from the dosimetry calculation.

Group Type EXPERIMENTAL

Tositumomab 450 mg

Intervention Type DRUG

Unlabeled TST

Tositumomab 35 mg

Intervention Type DRUG

TST labeled with 185 megaBecqueral (mbq) of iodine 131

Interventions

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Tositumomab 450 mg

Unlabeled TST

Intervention Type DRUG

Tositumomab 35 mg

TST labeled with 185 megaBecqueral (mbq) of iodine 131

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients must have evidence of persistent or progressive follicular grade, 1, 2 or 3 or marginal zone B-cell non-Hodgkin's lymphoma.
* Must have received at least two prior courses of systemic treatment including at least one treatment of rituximab (lymphoma must not have progressed during their most recent systemic chemotherapy treatment).
* Must have evidence that their lymphoma expresses CD20 antigen and have adequate renal and hepatic function.

Exclusion Criteria

* Received chemotherapy, radiation therapy, immunosuppressants or cytokine treatment within 4 weeks prior to study entry.
* Have active obstructive hydronephrosis.
* Had prior autologous hematopoietic stem cell transplant or any allogenic stem cell transplant.
* Have active infection requiring IV antibiotics.
* Have brain or leptomeningeal metastasis.
* Had previous allergic reaction to iodine, previously received radioimmunotherapy or are currently receiving approved or experimental anti-cancer drugs.
* Patients who are pregnant or breast feeding, have known HIV infection, or are Human anti-murine antibody (HAMA) positive.
* Other criteria will be evaluated at the screening visit.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Calgary, Alberta, Canada

Site Status

GSK Investigational Site

Edmonton, Alberta, Canada

Site Status

GSK Investigational Site

Halifax, Nova Scotia, Canada

Site Status

GSK Investigational Site

Hamilton, Ontario, Canada

Site Status

GSK Investigational Site

Ottawa, Ontario, Canada

Site Status

GSK Investigational Site

Toronto, Ontario, Canada

Site Status

GSK Investigational Site

Toronto, Ontario, Canada

Site Status

GSK Investigational Site

Montreal, Quebec, Canada

Site Status

GSK Investigational Site

Montreal, Quebec, Canada

Site Status

GSK Investigational Site

Québec, Quebec, Canada

Site Status

GSK Investigational Site

Québec, Quebec, Canada

Site Status

Countries

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Canada

References

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Olney HJ, Freeman MA, Stewart DA, Mangel JE, White DJ, Elia-Pacitti JO. Prolonged progression-free survival and preserved quality of life in the Canadian prospective study of tositumomab and iodine(131)-tositumomab for previously treated, rituximab-exposed, indolent non-Hodgkin lymphoma. Leuk Lymphoma. 2014 Dec;55(12):2754-60. doi: 10.3109/10428194.2014.894190. Epub 2014 Apr 3.

Reference Type DERIVED
PMID: 24528219 (View on PubMed)

Other Identifiers

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393229/032

Identifier Type: -

Identifier Source: org_study_id