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

NCT00073957 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 2003P000182CDR0000341437
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Response Rate = Complete and Partial Response at 12 Weeks.

  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

  12 weeks

• Best Response

  This data is the best overall response achieved by patients by the 12 month period.

  12 months

Secondary Outcomes (1)

• Event Free Survival

  12 months

Study Arms (1)

Y-90 Ibritumomab Tiuxetan

EXPERIMENTAL

Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab and central nervous system prophylaxis with Cytarabine or liposomal cytarabine

Biological: rituximab; Drug: cytarabine; Drug: liposomal cytarabine; Radiation: yttrium Y 90 ibritumomab tiuxetan

Interventions

rituximab BIOLOGICAL

Also known as: Rituxan

Y-90 Ibritumomab Tiuxetan

cytarabine DRUG

to be used for CNS prophylaxis

Also known as: cytosine arabinoside

Y-90 Ibritumomab Tiuxetan

liposomal cytarabine DRUG

to be used as CNS prophylaxis

Also known as: Depocyte

Y-90 Ibritumomab Tiuxetan

yttrium Y 90 ibritumomab tiuxetan RADIATION

Also known as: Zevalin

Y-90 Ibritumomab Tiuxetan

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Fletcher Allen Health Care - Medical Center Campus

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Immunoblastic; Lymphoma, Large-Cell, Anaplastic

Interventions

Rituximab; Cytarabine; ibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma, T-Cell

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Robin Joyce, MD
• Organization: Beth Israel Deaconess Medical Center

rjoyce@bidmc.harvard.edu

617-667-9920

Study Officials

• Robin Joyce, MD

  Beth Israel Deaconess Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: Standard Phase 2

Study Record Dates

• First Submitted: December 10, 2003
• First Posted: December 11, 2003
• Study Start: December 1, 2003
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: January 23, 2018
• Results First Posted: January 23, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)