Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Follicular

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Follicular Lymphoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Rituximab

Antineoplastic Agents, Immunological

Immunologic Factors

2 x iv infusions of 11.1 MBq/kg. 1st infusion at week 1, 2nd during weeks 9-13. 2nd infusion may be reduced to 7.4MBq/kg in the case of grade 3 haematological toxicity following the 1st infusion.

90Y Ibritumomab tiuxetan

All patients receive 2 x iv infusions of 250 mg/m2 Rituximab given 7-8 days apart prior to each zevalin infusion. The 2nd rituximab infusion is given immediately prior to Zevalin.

In addition patients with greater than 20% bone marrow involvement at screening receive rituximab pretreatment prior to entering the main treatment phase of the trial, consisting of 4 x weekly iv doses of rituximab(375 mg/m2). This is followed by a repeat bone marrow biopsy, bone marrow involvement must have fallen to \<= 20% to enter the main treatment phase of the trial.

Timothy Illidge, Prof

90Y Ibritumomab tiuxetan (zevalin) has demonstrated consistently high response rates in patients who have received previous treatment for lymphoma. More than two-thirds of the patients who achieve CR go on to experience durable remissions lasting for years. Despite these highly promising clinical results with radioimmunotherapy (RIT) in relapsed follicular lymphoma there is very little data using RIT in previously untreated follicular lymphoma. The objective of this trial is to evaluate the safety and efficacy of two fractions of Zevalin in patients with previously untreated follicular lymphoma in a Phase II study.

Phase II Study of Fractionated 90Y Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy as an Initial Therapy of Follicular Lymphoma

Phase II Study of Fractionated 90Y Ibritumomab Tiuxetan (Zevalin)

According to Cheson criteria to standardize response for non-Hodgkin's lymphoma, 1999.

To be assessed for patients achieving a response, including assessment of overall survival and time until next treatment.

Bayer

The Christie NHS Foundation Trust

Lead Clinical Trial Manager

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Sandra Jeane Horning

To test a new way to approach hematopoietic stem cell transplantation for Relapsed or Resistant Non-Hodgkin's Lymphoma.

This is a single center phase I dose escalation trial of a single course of IDEC-Y2B8 (90Y-ibritumomab tiuxetan, Zevalin) with autologous peripheral blood progenitor cell infusion followed by high dose chemotherapy and AHCT for patients with relapsed or refractory B-cell NHL. In step one, an imaging dose of IDEC-In2B8 (111In- ibritumomab tiuxetan, Zevalin) will be followed one week later by IDEC-Y2B; both will be preceded by an infusion of 250 mg/m2 rituximab. Imaging will be done immediately (within 1 hr), at 4 - 6 hours and at 1, 3, and 6 days after 90Y-ibritumomab tiuxetan.

90Y-IBRITUMOMAB Tiuxetan and AHCI With HD Chemotherapy and Autologous Transplantation for Relapsed or Resistant NHL

90Y-Ibritumomab Tiuxetan and Autologous Hematopoietic Cell Infusion Followed by High Dose Chemotherapy and Autologous Transplantation for Relapsed or Resistant Non-Hodgkin's Lymphoma

Biogen

National Institutes of Health (NIH)

Stanford University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase II Study of Fractionated 90Y Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy as an Initial Therapy of Follicular Lymphoma	NCT01493479	Follicular Lymp...	90Y Ibritumomab... Rituximab	18 Years -	The Christie NHS Foundation Trust
90Y-IBRITUMOMAB Tiuxetan and AHCI With HD Chemotherapy and Autologous Transplantation for Relapsed or Resistant NHL	NCT00186589	Lymphoma, Non-H... Blood and Marro...	90Y Ibritumomab...	18 Years - 70 Years	Stanford University
90Y-IBRITUMOMAB Tiuxetan and AHCI With HD Chemotherapy and Autologous Transplantation for Relapsed or Resistant NHL	NCT00186589	Lymphoma, Non-H... Blood and Marro...	90Y Ibritumomab...	18 Years - 70 Years	Stanford University

Spots Global Cancer Trial Database for 90y ibritumomab tiuxetan