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Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00695409 |
RATIONALE: Monoclonal antibodies such as rituximab and yttrium Y 90 ibritumomab tiuxetan can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy work in different ways to kill cancer cells or stop them from growing. Giving rituximab, yttrium Y 90 ibritumomab tiuxetan, and combination chemotherapy before an autologous peripheral blood stem cell transplant may be an effective treatment for non-Hodgkin lymphoma.
PURPOSE: This phase II trial is studying how well giving yttrium Y 90 ibritumomab tiuxetan and high-dose combination chemotherapy with or without rituximab followed by an autologous stem cell transplant works in treating patients with relapsed B-cell non-Hodgkin lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: carmustine Drug: cytarabine Drug: etoposide Drug: melphalan Drug: rituximab Drug: yttrium Y 90 ibritumomab tiuxetan Procedure: autologous hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Yttrium-90-Labeled Anti-CD20 Monoclonal Antibody in Combination With High-Dose Beam (BCNU, Etoposide, Cytarabine and Melphalan) Followed by Autologous Stem Cell Transplantation for Patients With Poor Risk/Relapsed B-Cell Lymphoma |
Estimated Enrollment: | 108 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | March 2018 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE:
Patients undergo pre-therapy biodistribution imaging with infusion of indium In 111 ibritumomab tiuxetan over 10 minutes on day -21 and undergo whole-body gamma camera images at approximately 2-24 hours, 48-72 hours, and an optional third scan at approximately 90-120 hours after the infusion. Patients with unfavorable biodistribution are removed from study. Patients with favorable biodistribution undergo repeat evaluation of rituximab levels in the blood on day -16. If rituximab levels are ≥ 10 μg/mL, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14. Patients with unacceptably low antibody levels receive rituximab prior to administration of yttrium Y 90 ibritumomab tiuxetan on day -14.
After completion of study treatment, patients are followed periodically.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Biopsy-proven diagnosis of low- or intermediate-grade* non-Hodgkin lymphoma (NHL) including any of the following:
Patient either relapsed after achieving a complete response (CR) or partial response (PR) to prior therapy, has never responded to prior therapy, or has poor-risk disease
Sensitivity of disease based on 1 of the following:
Poor-risk disease defined as any of the following:
Age-adjusted International Prognostic Index High (3 risk factors) or High-Intermediate (2 risk factors) based on the following risk factors:
No abnormal cytogenetic study not related to the underlying lymphoma on the bone marrow aspirate sample prior to stem cell collection
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |
City of Hope Comprehensive Cancer Center | Recruiting |
Duarte, California, United States, 91010-3000 | |
Contact: Phyllis Broene 800-826-4673 PBroene@coh.org |
Principal Investigator: | Amrita Y. Krishnan, MD | Beckman Research Institute |
Responsible Party: | City of Hope Comprehensive Cancer Center ( Amrita Y. Krishnan ) |
Study ID Numbers: | CDR0000597569, CHNMC-07076 |
Study First Received: | June 10, 2008 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00695409 |
Health Authority: | Unspecified |
recurrent mantle cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma recurrent adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma |
stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage III adult immunoblastic large cell lymphoma stage IV adult immunoblastic large cell lymphoma recurrent adult immunoblastic large cell lymphoma |
Melphalan Lymphoma, Mantle-Cell Lymphoma, small cleaved-cell, diffuse Lymphoma, Follicular Etoposide phosphate Lymphoma, large-cell, immunoblastic Lymphoma, B-Cell Lymphoma, large-cell Antibodies, Monoclonal Lymphoma, Large-Cell, Immunoblastic Lymphoma Etoposide Cytarabine |
Immunoglobulins Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Rituximab Carmustine Mantle cell lymphoma Recurrence Lymphatic Diseases Antibodies B-cell lymphomas Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Follicular lymphoma |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents |
Antiviral Agents Pharmacologic Actions Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents |