Clinical Trial: NCT00073957 - My Cancer Genome

NCT00073957

Description:

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.

Related Conditions:

Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-Cell Lymphoma
Diffuse Large B-Cell Lymphoma
Mediastinal Large B-Cell Lymphoma
T-Cell Non-Hodgkin Lymphoma

Recruiting Status:

Completed

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT00073957

Trial Eligibility

Document

Title

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

Clinical Trial IDs

ORG STUDY ID: 2003P000182
SECONDARY ID: CDR0000341437
NCT ID: NCT00073957

Conditions

Lymphoma

Interventions

Drug	Synonyms	Arms
rituximab	Rituxan	Y-90 Ibritumomab Tiuxetan
cytarabine	cytosine arabinoside	Y-90 Ibritumomab Tiuxetan
liposomal cytarabine	Depocyte	Y-90 Ibritumomab Tiuxetan

Purpose

Detailed Description

      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.

Trial Arms

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

Eligibility 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

Maximum Eligible Age:	120 Years
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Response Rate = Complete and Partial Response at 12 Weeks.
Time Frame:	12 weeks
Safety Issue:
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 other nodes Stable disease Failure to attain CR/PR or Progressive disease or Relapsed disease : the appearance of any new lesion or the (a) FDG-avid or PET positive prior to therapy; PET positive at prior sites of disease and no new sites on CT or PET Any new lesion or increase by ≥ 50% of previously involved sites from nadir Appearance of a new lesion(s) > 1.5 cm in any axis, ≥ 50% increase in SPD of more than one node, or ≥ 50% increase in longest diameter of a previously identified node > 1 cm in short axis > 50% increase from nadir in the SPD of any previous lesions New or recurrent involvement Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy

Secondary Outcome Measures

Measure:	Event Free Survival
Time Frame:	12 months
Safety Issue:
Description:	the median time point at which a participants experienced and event or toxicity or progression

Details

Phase:	Phase 2
Primary Purpose:	Interventional
Overall Status:	Completed
Lead Sponsor:	Beth Israel Deaconess Medical Center

Trial Keywords

recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
anaplastic large cell lymphoma

Last Updated

January 23, 2018

Clinical Trials /

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