Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

recurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomaanaplastic 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: rituximabDrug: cytarabineDrug: liposomal cytarabineRadiation: yttrium Y 90 ibritumomab tiuxetan

Interventions

rituximabBiological

Also known as: Rituxan

Y-90 Ibritumomab Tiuxetan

cytarabineDrug

to be used for CNS prophylaxis

Also known as: cytosine arabinoside

Y-90 Ibritumomab Tiuxetan

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
liposomal cytarabine
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
View registry record

Eligibility Criteria

Age18 Years - 120 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Beth Israel Deaconess Medical Center
Otherlead

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Fletcher Allen Health Care - Medical Center Campus

Burlington, Vermont, 05401, United States

MeSH Terms

Conditions

LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticLymphoma, Large-Cell, Anaplastic

Interventions

RituximabCytarabineibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Results Point of Contact

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

Study Officials

Robin Joyce, MD
Beth Israel Deaconess Medical Center
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

25 participants (actual enrollment reported by the registry).

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

Study Record Dates

First Submitted

December 10, 2003

First Posted

December 11, 2003

Study Start

December 2003

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (1)

Y-90 Ibritumomab Tiuxetan

Interventions

Registry intervention entries

Eligibility Criteria

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (1)

Y-90 Ibritumomab Tiuxetan

Interventions

Registry intervention entries

Eligibility Criteria

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations