Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, B-Cell, Marginal Zone

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Marginal Zone Lymphoma

B-cell Lymphoma

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Antibodies

Antibodies, Monoclonal

Rituximab

Immunoglobulins

Antineoplastic Agents, Immunological

Immunologic Factors

Ibritumomab Tiuxetan (Zevalin) + Rituximab

IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³

IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:

0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³

Ibritumomab Tiuxetan

Izidore S. Lossos, MD

Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL).

This phase II study will assess the clinical response rate to Ibritumomab Tiuxetan in patients with untreated nodal, splenic and non-gastric extranodal MZL as well as in antibiotic resistant patients with mucosa-associated lymphoid tissue (MALT) gastric lymphoma.

Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma

Phase II Study of Ibritumomab Tiuxetan (Zevalin®) in Patients With Previously Untreated Marginal Zone Lymphoma

The overall response rate (ORR) including complete response (CR), complete response unconfirmed (CRu), and partial response (PR) in participants receiving protocol therapy.

The time from the start of protocol therapy until the first documented or confirmed disease progression, or death related to study disease, whichever is earlier.

Percentage of participants still alive without disease progression five years after the date of protocol therapy initiation.

The time from the date of initiation of study treatment until date of death from any cause for all participants.

Percentage of participants still alive five years after the date of protocol therapy initiation.

Number of participants with treatment-related (possible, probable, or definite) grade 3 or higher non-hematologic adverse events.

University of Miami

Professor

Ibritumomab Tiuxetan (Zevalin) + Rituximab

Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³

Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:

0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³

Zevalin + Rituximab

Age, Continuous

Data reported for only 16 of 18 participants due to 2 participants withdrawing consent.

Sex: Female, Male

Stage I/II

Stage III/IV

Number of participants grouped by extent (reach) and location of the lymphoma at Baseline: Stage I, Stage II, Stage III and Stage IV. The stage depends on both the place where the malignant tissue is located and on systemic symptoms due to the lymphoma ("B symptoms": night sweats, weight loss of \>10% or fevers).The higher the stage number, the larger the extent of the lymphoma, and/or the more it has grown into nearby tissues.

Disease Stage

0, 1 sites

2 or more sites

Number of participants grouped by the number of sites outside of the lymph nodes where lymphoma is present at baseline.

Extranodal disease sites

Number of participants grouped according to their Eastern Cooperative Oncology Group (ECOG) performance status or score at baseline. The ECOG score attempts to quantify patients' general well being and level of activities of daily life. The higher the score, the less healthy the patient's general well being and lower the the patient's level of the daily activity.

Eastern Cooperative Oncology Group (ECOG) Performance Status

Number of participants grouped by the presence of lymphoma cells in the bone marrow at baseline.

Bone Marrow involvement

Normal

Elevated

Number of participants grouped by serum levels of LDH at baseline.

Lactate dehydrogenase (LDH) Levels

5 and less cm

More than 5 cm

Number of patients grouped by the size of large tumors or lymph nodes in centimeters (cm) present at baseline.

Bulky disease (cm)

Low risk

Low/intermediate risk

Intermediate/high risk

High risk

Number of participants grouped by their prognosis with aggressive non-Hodgkin's lymphoma. One point is assigned for each of the following risk factors:

* Age \> 60 years
* Stage III/IV disease
* Elevated serum LDH
* ECOG/Zubrod performance status of 2, 3, or 4
* \> 1 extranodal site

The sum of the points allotted correlates with the following risk groups:

* Low risk (0-1 points) - 5-year survival of 73%
* Low-intermediate risk (2 points) - 5-year survival of 51%
* High-intermediate risk (3 points) - 5-year survival of 43%
* High risk (4-5 points) - 5-year survival of 26%

International Prognostic Index (IPI) Risk Group

Intermediate risk

Number of participants grouped by their prognosis with follicular lymphoma. One point is assigned for each of the following factors:

* Age \> 60 years
* Stage III or IV disease
* \> 4 lymph node groups involved
* Serum hemoglobin \< 12 g/dL
* Elevated serum LDH

The sum of the points allotted correlates with the following risk groups:

* Low risk (0-1 points) - 5 and 10-year survivals of 91% and 71%, respectively
* Intermediate risk (2 points) - 5 and 10-year survivals of 78% and 51%, respectively
* High risk (3-5 points) - 5 and 10-year survivals of 53% and 36%, respectively

Follicular Lymphoma International Prognostic Index (FLIPI) Risk Group

Data reported for only 16 of 18 enrolled participants due to 2 participants withdrawing consent.

Izidore S. Lossos

Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy.

Rate of Progression-Free Survival

5-Year Rate of Progression-Free Survival (5-Year PFS)

Median overall survival by Kaplan-Meier method for all patients was not attained.

Spots Global Cancer Trial Database for Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial