Trial · NCT00453102

Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma

NCT00453102, Phase 2, Completed, University of Miami; results first posted 2016-01-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma. Trials, record NCT00453102. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00453102

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma
NCT number: NCT00453102
Status: Completed
Phases: Phase 2
Enrollment: 18 participants, actual
Lead sponsor: University of Miami
Conditions: Marginal Zone Lymphoma
Interventions: Rituximab, Ibritumomab Tiuxetan
First posted: 2007-03-28
Last updated: 2016-01-01
Results first posted: 2016-01-01
Limitations and caveats: Data reported for only 16 of 18 enrolled participants due to 2 participants withdrawing consent.

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy.	12 weeks post-therapy	The overall response rate (ORR) including complete response (CR), complete response unconfirmed (CRu), and partial response (PR) in participants receiving protocol therapy.
Secondary	Rate of Progression-Free Survival	End of study.	The time from the start of protocol therapy until the first documented or confirmed disease progression, or death related to study disease, whichever is earlier.
Secondary	5-Year Rate of Progression-Free Survival (5-Year PFS)	5 Years	Percentage of participants still alive without disease progression five years after the date of protocol therapy initiation.
Secondary	Overall Survival (OS) Rate	End of Study	The time from the date of initiation of study treatment until date of death from any cause for all participants.
Secondary	5 Year Rate of Overall Survival (5-Year OS)	5 Years	Percentage of participants still alive five years after the date of protocol therapy initiation.
Secondary	Number of Participants With Unacceptable Toxicity.	Up to 12 weeks post-therapy	Number of participants with treatment-related (possible, probable, or definite) grade 3 or higher non-hematologic adverse events.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy.	12 weeks post-therapy		percentage of participants	NUMBER
SECONDARY	Rate of Progression-Free Survival	End of study.		months	MEDIAN
SECONDARY	5-Year Rate of Progression-Free Survival (5-Year PFS)	5 Years		percentage of participants	NUMBER
SECONDARY	Overall Survival (OS) Rate	End of Study	Median overall survival by Kaplan-Meier method for all patients was not attained.	months	NUMBER
SECONDARY	5 Year Rate of Overall Survival (5-Year OS)	5 Years		percentage of participants	NUMBER
SECONDARY	Number of Participants With Unacceptable Toxicity.	Up to 12 weeks post-therapy		participants	NUMBER

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy.	Zevalin + Rituximab	87.5	90% Confidence Interval 65.6 to 97.7	percentage of participants
Rate of Progression-Free Survival	Zevalin + Rituximab	47.6	Full Range 4.0 to 93.3	months
5-Year Rate of Progression-Free Survival (5-Year PFS)	Zevalin + Rituximab	40	90% Confidence Interval 19.9 to 59.5	percentage of participants
Overall Survival (OS) Rate	Zevalin + Rituximab	NA		months
5 Year Rate of Overall Survival (5-Year OS)	Zevalin + Rituximab	71.8	90% Confidence Interval 46.8 to 86.5	percentage of participants
Number of Participants With Unacceptable Toxicity.	Zevalin + Rituximab	2		participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Zevalin + Rituximab	18
Overall Study	COMPLETED	Zevalin + Rituximab	16
Overall Study	NOT COMPLETED	Zevalin + Rituximab	2

Source ClinicalTrials.gov

Adverse events77

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal Pain (Grade 1-2)	Gastrointestinal disorders	Zevalin + Rituximab	3	16	4
other	Alkaline phosphatase increased	Metabolism and nutrition disorders	Zevalin + Rituximab	2	16	6
other	Allergic Reaction	Injury, poisoning and procedural complications	Zevalin + Rituximab	3	16	3
other	Anorexia	Gastrointestinal disorders	Zevalin + Rituximab	1	16	1
other	Anxiety	Nervous system disorders	Zevalin + Rituximab	1	16	1
other	Arthritis (non-septic)	Musculoskeletal and connective tissue disorders	Zevalin + Rituximab	1	16	1
other	Atelectasis	Respiratory, thoracic and mediastinal disorders	Zevalin + Rituximab	1	16	1
other	Back Pain	Gastrointestinal disorders	Zevalin + Rituximab	2	16	2
other	Blurred vision	Eye disorders	Zevalin + Rituximab	1	16	1
other	Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	Zevalin + Rituximab	1	16	1

1 to 10 of 77Source ClinicalTrials.gov

See all 77 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Zevalin + Rituximab
Total, other adverse events	Zevalin + Rituximab	15	16
Total, serious adverse events	Zevalin + Rituximab	2	16

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25315074	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00453102

GET https://conductscience.org/api/trials/v1/NCT00453102/events?page=2

API reference For AI assistants