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Fludarabine Monophosphate Followed by Iodine I 131 Tositumomab for Untreated Low-grade and Follicular Non-Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma, Non-Hodgkin, Non-Hodgkin's Lymphoma

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Trial Information

Fludarabine Monophosphate Followed by Iodine I 131 Tositumomab for Untreated Low-grade and Follicular Non-Hodgkin's Lymphoma


Inclusion Criteria:



- Patients must be age 18 years or older.

- Patients must have a histologically-confirmed diagnosis of low-grade or follicular
non-Hodgkin's B-cell lymphoma.

- Patients must have Ann Arbor stage III or IV extent of disease after completing
staging.

- Patients must have bi-dimensionally measurable disease. At least one lesion must
have both perpendicular diameters > 2 cm.

- Patients must have evidence that their tumor expresses the CD20 antigen by
immunohistochemistry or flow cytometry.

- Patients must have no previous treatment for NHL.

- Patients must have a Karnofsky performance status of at least 60% and an anticipated
survival of at least 3 months.

- Patients must have absolute granulocyte count greater than or equal to 1500 cells/mm3
and a platelet count > 100,000 cells/mm3 within 14 days of study entry and not
require sustained support with hematopoietic cytokines or transfusion of blood
products.

- Patients must have adequate renal and hepatic function.

- Patients must sign IRB approved informed consent form(s) prior to study entry.

Exclusion Criteria:

- Patients who received systemic steroids within 1 week of study entry, except patients
on maintenance steroid therapy for a non-cancerous disease.

- Patients with evidence of active infection requiring intravenous antibiotics at the
time of study entry.

- Patients with New York Heart Association class III or IV heart disease or other
serious illness that would preclude evaluation.

- Patients with known HIV Infection.

- Patients with known brain or leptomeningeal metastases.

- Patients who are pregnant or nursing. Patients of childbearing potential must
undergo a pregnancy test at screening and on the day fludarabine treatment is
started. Treatment is not to be administered until a negative result is obtained.
Males and females must agree to use effective contraception for 6 months following
the iodine I 131 tositumomab therapy.

- Patients with prior malignancy other than lymphoma, except for adequately-treated
skin cancer in situ cervical cancer, or other cancer for which the patient has been
disease-free for 5 years.

- Patients with hypersensitivity to fludarabine.

- Patients who are receiving either approved or non-approved (through another protocol)
anti-cancer drugs or biologics.

- Patients who are HAMA positive.

- Patients with previous allergic reaction to iodine. This does not include reacting
to intravenous iodine containing contrast materials.

Inclusion Criteria for Iodine I 131 Tositumomab Therapy

- Patients who completed 3 cycles of fludarabine.

- Patients must have absolute granulocyte count ≥ to 1500/mm3, platelet count of ≥
100,000/mm3 (≥ 150,000/mm3 if > 25% bone marrow involvement at restaging), and not
require sustained support with hematopoietic cytokines or transfusions with blood
products.

- Patients must have adequate renal and hepatic function.

Exclusion criteria for Antibody Therapy

- Patients with active obstructive hydronephrosis.

- Patients with evidence of active infection requiring intravenous antibiotics.

- Patients who are pregnant.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants With Any Adverse Event (AE)

Outcome Description:

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily have to have a causal relationship (association) with this treatment. Therefore, an AE was any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not it was considered to be related to the medicinal product. Laboratory abnormalities were recorded as AEs only if they were associated with clinical sequelae and/or required an intervention.

Outcome Time Frame:

First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST dosimetric dose (DD) (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

393229/023

NCT ID:

NCT00933335

Start Date:

August 1998

Completion Date:

December 2009

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • Non-Hodgkin's Lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

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