Clinical trial · Interventional
Study of Safety and Efficacy of a Sequential Regimen Consisting of Three Cycles of Fludarabine Followed by Tositumomab and Iodine I 131 Tositumomab
Fludarabine Monophosphate Followed by Iodine I 131 Tositumomab for Untreated Low-grade and Follicular Non-Hodgkin's Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single-arm, single institution, phase II study of fludarabine monophosphate followed by Iodine I 131 Tositumomab for patients with previously untreated, advanced-stage (stage III or IV) low-grade, transformed low-grade and follicular non-Hodgkin's lymphoma. The primary objective of the study will be to evaluate the safety of this treatment combination and the secondary endpoint will be to evaluate efficacy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tositumomab and Iodine I 131 Tositumomab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- description
- Patients will first receive an abbreviated course of three cycles of fludarabine (25 mg/m2 for 5 days every 5 weeks). Iodine I 131 tositumomab will be initiated 6 to 8 weeks after completion of fludarabine. Patients will undergo dosimetry studies to determine the appropriate patient-specific activity of iodine I 131 tositumomab required to deliver a fixed dose of 75 cGy. The dose will be attenuated to 65 cGy for patients with platelet counts between 100,000 and 150,000/micoliter.
- interventionNames
- Biological: Tositumomab and Iodine I 131 Tositumomab
Primary outcomes (25)
- measure
- Number of Participants With Any Adverse Event (AE)
- timeFrame
- 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)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTLeonard JP, Coleman M, Kostakoglu L, Chadburn A, Cesarman E, Furman RR, Schuster MW, Niesvizky R, Muss D, Fiore J, Kroll S, Tidmarsh G, Vallabhajosula S, Goldsmith SJ. Abbreviated chemotherapy with fludarabine followed by tositumomab and iodine I 131 tositumomab for untreated follicular lymphoma. J Clin Oncol. 2005 Aug 20;23(24):5696-704. doi: 10.1200/JCO.2005.14.803. PMID 16110029