Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

B-cell Lymphoma

Lymphosarcoma

All Drugs and Chemicals

Antineoplastic Agents

Anti-Infective Agents

Antirheumatic Agents

Micronutrients

Antibodies

Antibodies, Monoclonal

Etoposide

Cytarabine

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Rituximab

Etoposide phosphate

Immunoglobulins

Iodine

Cadexomer iodine

Tositumomab I-131

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Antimetabolites

Antiviral Agents

Induction:Cyclophosphamide, Etoposide, and Rituxan (rituximab) followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar (tositumomab)

1.5g/m2 IV over 1 hour on days 1-4 of induction for a total dose of 6.0g/m2

cyclophosphamide

300mg/m2 IV over 1 hour every 12 on days 1-3 of induction for a total dose of 1.8 g/m2.

etoposide

375mg/m2 each week x 4 weeks of induction, beginning on day 1

rituximab

3g/m2 IV over 1 hour every 12 during consolidation for a total of 8 doses

cytarabine

45mg/m2/day IV over 30 minutes on days 1, 2, 3 during consolidation

doxorubicin

450mg unlabeled tositumomab over 1 hour, followed by 5 millicurie (mCi) Iodine I-131 labeled tositumomab over 20 minutes on day 0. Therapeutic dose of labeled tositumomab will be administered on day 15.

tositumomab

David Rizzieri, MD

The purpose of this study is to determine whether using high-dose chemotherapy, monoclonal antibodies, and targeted radioimmunotherapy will slow the progression of disease in patients with high-risk Non-Hodgkin's Lymphoma (NHL).

This is a phase II efficacy trial for patients with untreated, high-risk, B-cell Non-Hodgkin's Lymphoma. The study will evaluate the efficacy and safety of high-dose chemotherapy combined with monoclonal antibodies and targeted radioimmunotherapy in previously untreated patients with high-risk NHL

Chemotherapy With Monoclonal Antibody and Radioimmunotherapy for High-Risk B-Cell Non-Hodgkins Lymphoma

Dose-Intensive Chemotherapy Combined With Monoclonal Antibody Therapy and Targeted Radioimmunotherapy for Untreated Patients With High-Risk B-Cell Non-Hodgkin's Lymphoma

Progression-free survival is measured from the first day of induction chemotherapy to the date of progression, relapse or death. Definitions of response criteria are as described by Cheson. Progressive Disease: \>50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for PDs or nonresponders, appearance of any new lesion during or at the end of therapy.

Disease-free survival is measured from the date of CR or CRu to date of relapse or death

Overall Survival is measured from the first day of chemotherapy until death from any cause.

Percent of subjects who achieved a complete response (CR) or partial response (PR) any time during the treatment period.

CR = complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.

PR =

1. \>/= 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses.
2. No increase should be observed in the size of other nodes, liver, or spleen.
3. Splenic and hepatic nodules must regress by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter.
4. Except splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.
5. Patients who achieve a CR by the above criteria, but who have persistent morphologic bone marrow involvement will be considered partial responders.
6. No new sites of disease should be observed.

The number of patients who develop secondary malignancies including solid tumors, acute leukemia and myelodysplasia or other bone marrow failure syndromes.

GlaxoSmithKline

Duke University

All adverse events are reported whether or not they are considered related to study regimen.

Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar

Experimental: Induction + Consolidation + Bexxar

Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy:Bexxar

All Subjects

Age, Categorical

Age, Customized

Sex: Female, Male

United States

Region of Enrollment

Anne Beaven, MD

Induction: Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar

1 Year Progression-free Survival Rate

Subjects who achieved a complete response. 9 patients experienced disease progression; 4 patients died.

4 patients were lost-to-follow-up and 11 patients are still living, so DFS was calculated using the last date of follow-up.

Disease-free Survival

Overall Survival

Induction: Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar)

Spots Global Cancer Trial Database for Chemotherapy With Monoclonal Antibody and Radioimmunotherapy for High-Risk B-Cell Non-Hodgkins Lymphoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial