Expired Study
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Boston, Massachusetts 02215


Purpose:

RATIONALE: Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan and rituximab, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining yttrium Y 90 ibritumomab tiuxetan with rituximab may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining yttrium Y 90 Ibritumomab tiuxetan with rituximab in treating patients who have relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma.


Study summary:

OBJECTIVES: - Determine the best overall response in patients with relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma treated with yttrium Y 90 ibritumomab tiuxetan and rituximab. - Determine the event-free survival of patients treated with this regimen. - Determine the toxicity of this regimen in these patients. OUTLINE: This is an open-label, multicenter study. - Radioimmunotherapy: Patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 (for imaging only); yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8; and rituximab IV over 3-4 hours on days 1, 8, 15, 22, 29, and 36. - CNS ( central nervous system)prophylaxis: Patients receive CNS prophylaxis comprising intrathecal (IT) methotrexate or IT cytarabine on days 15, 22, 29, and 36 OR IT cytarabine (liposomal) on days 15 and 29. - Maintenance rituximab: Patients are assessed for response at week 14. Beginning at month 6, patients with stable or responding disease receive maintenance therapy comprising rituximab IV over 3-4 hours once weekly for 4 weeks. Maintenance therapy repeats every 6 months for 2 years (total of 4 courses) in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma, including any of the following: - B-cell diffuse large cell variant - Immunoblastic - Mediastinal (thymic) large cell - T-cell/histiocyte-rich - Anaplastic large B-cell - Intravascular large B-cell - Lymphomatoid granulomatosis - Relapsed or refractory disease after at least 1 prior chemotherapy regimen and requires further treatment - Relapsed disease, defined as the following: - Appearance of any new lesion OR increase of at least 50% in the size of a previously involved site - 50% increase in greatest diameter of any previously identified node greater than 1 cm in the short axis OR in the sum of the perpendicular diameter (SPD) of more than 1 node - Progressive disease, defined as the following: - 50% increase from nadir in the SPD of any previously identified abnormal node - Appearance of any new lesion during or at the end of therapy - CD20-positive disease by immunohistochemistry - Bidimensionally measurable disease - At least 1 lesion at least 2.0 cm by CT scan - Less than 25% bone marrow involvement by lymphoma - No transformed lymphoma from indolent to aggressive - No HIV- or AIDS-related lymphoma - No hypocellular bone marrow - No marked reduction in bone marrow precursors of 1 or more cell lines (e.g., granulocytic, megakaryocytic, or erythroid) - No CNS lymphoma - Ineligible for myeloablative therapy OR refused transplantation - Ineligible for any other open yttrium Y 90 ibritumomab tiuxetan investigational protocols PATIENT CHARACTERISTICS: Age - 18 and over Performance status - WHO 0-2 Life expectancy - At least 3 months Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Lymphocyte count no greater than 5,000/mm^3 (for patients with small lymphocytic lymphoma) - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 2.0 mg/dL Renal - Creatinine no greater than 2.0 mg/dL Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 1 year after study participation - No concurrent serious nonmalignant disease or infection that would preclude study participation - No human antimurine antibody reactivity PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No prior autologous bone marrow transplantation - No prior peripheral blood stem cell rescue - No prior failed stem cell collection - Prior rituximab within the past 90 days allowed provided patient has fludeoxyglucose-avid disease that is also indium In 111 ibritumomab tiuxetan-avid disease in at least 1 lesion - More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - No prior radioimmunotherapy - No prior external beam radiotherapy (involved field or regional) to more than 25% of active bone marrow Surgery - More than 4 weeks since prior major surgery (except diagnostic surgery) Other - Recovered from all prior therapy - More than 4 weeks since prior therapy for lymphoma - More than 8 weeks since prior phase II investigational drugs - No other concurrent antineoplastic therapy


Study is Available At:


Original ID:

2003P000182


NCT ID:

NCT00073957


Secondary ID:

CDR0000341437


Study Acronym:


Brief Title:

Y 90 Ibritumomab Tiuxetan &Rituximab Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma


Official Title:

Zevalin And Rituxan For The Treatment Of Relapsed Or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

120 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Beth Israel Deaconess Medical Center


Oversight Authority:

Unspecified


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

25


Enrollment Type:

Actual


Overall Contact Information

Official Name:Robin Joyce, MD
Study Chair
Beth Israel Deaconess Medical Center

Study Dates

Start Date:December 2003
Completion Date:January 1, 2012
Completion Type:Actual
Primary Completion Date:January 1, 2012
Primary Completion Type:Actual
Verification Date:December 2017
Last Changed Date:December 21, 2017
First Received Date:December 10, 2003
First Results Date:April 12, 2017

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Event Free Survival
Time Frame:12 months
Safety Issues:False
Description:the median time point at which a participants experienced and event or toxicity or progression
Outcome Type:Primary Outcome
Measure:Best Response
Time Frame:12 months
Safety Issues:False
Description:This data is the best overall response achieved by patients by the 12 month period.
Outcome Type:Primary Outcome
Measure:Response Rate = Complete and Partial Response at 12 Weeks.
Time Frame:12 weeks
Safety Issues:False
Description:Definition Nodal Masses Spleen, Liver Bone Marrow CR Disappearance of all evidence of disease Partial response Regression and no new sites ≥ 50% decrease in sum of the perpendicular dimension of up to 6 largest dominant masses; no increase in size of othe

Study Interventions

Intervention Type:Biological
Name:rituximab
Arm Name:Y-90 Ibritumomab Tiuxetan
Other Name:Rituxan
Intervention Type:Drug
Name:cytarabine
Description:to be used for CNS prophylaxis
Arm Name:Y-90 Ibritumomab Tiuxetan
Other Name:cytosine arabinoside
Intervention Type:Drug
Name:liposomal cytarabine
Description:to be used as CNS prophylaxis
Arm Name:Y-90 Ibritumomab Tiuxetan
Other Name:Depocyte
Intervention Type:Radiation
Name:yttrium Y 90 ibritumomab tiuxetan
Arm Name:Y-90 Ibritumomab Tiuxetan
Other Name:Zevalin

Study Arms

Study Arm Type:Experimental
Arm Name:Y-90 Ibritumomab Tiuxetan
Description:Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab and central nervous system prophylaxis with Cytarabine or liposomal cytarabine

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Beth Israel Deaconess Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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