NCT00003716

Brief Summary

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have lymphoproliferative disorder that is associated with immunosuppression therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_2 lymphoma

Timeline
Completed

Started Mar 1998

Typical duration for phase_2 lymphoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1998

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.1 years until next milestone

First Posted

Study publicly available on registry

December 5, 2003

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

May 31, 2022

Status Verified

May 1, 2022

Enrollment Period

8.8 years

First QC Date

November 1, 1999

Last Update Submit

May 25, 2022

Conditions

Lymphoma

Keywords

childhood Burkitt lymphomachildhood immunoblastic large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult Burkitt lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult Burkitt lymphomastage IV childhood small noncleaved cell lymphomastage IV childhood large cell lymphomarecurrent childhood small noncleaved cell lymphomarecurrent childhood large cell lymphoma

Interventions

rituximabBIOLOGICAL

Eligibility Criteria

Age3 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Polyclonal or monoclonal B-cell lymphoproliferative disorder while under pharmacologic immune suppression for control of either allograft rejection or autoimmune disease Measurable disease as defined by one of the following: At least 1 tumor mass measuring 1.0 cm in largest dimension Greater than 25% marrow involvement Quantifiable extranodal disease Expression of CD20 antigen confirmed by biopsy or fine needle aspirate Progression of disease or stable disease following reduction of immunosuppressive medication and antiviral therapy Inability to further reduce immunosuppressive medication PATIENT CHARACTERISTICS: Age: 3 to 70 Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 50,000/mm3 Hepatic: Not specified Renal: Not specified Cardiovascular: No congestive heart failure Pulmonary: No pneumonitis Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No serious nonmalignant disease No active uncontrolled bacterial, viral, or fungal infections PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) No concurrent chemotherapy Endocrine therapy: At least 2 weeks since change in dosing and type of immunosuppressive drugs unless due to progression of disease Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery (except diagnostic surgery) Other: At least 30 days or 5 half-lives since other prior investigational drugs or whichever is longer

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

Sponsors & Collaborators

Study Sites (1)

Stanford University Medical Center

Stanford, California, 94305-5408, United States

Location

MeSH Terms

Conditions

LymphomaBurkitt LymphomaLymphoma, Large-Cell, ImmunoblasticDendritic Cell Sarcoma, Interdigitating

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinHistiocytic Disorders, MalignantHistiocytosis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Sandra J. Horning, MD

    Stanford University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

December 5, 2003

Study Start

March 1, 1998

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

May 31, 2022

Record last verified: 2022-05

Locations

US(1)