NCT00088881|TerminatedPhase 2Results

Rituximab, Combination Chemotherapy, and 90-Yttrium Ibritumomab Tiuxetan for Patients With Stage I or II Non-Hodgkin's Lymphoma

A Phase II Trial of R-CHOP Followed by Zevalin Radioimmunotherapy for Patients With Previously Untreated Stages I and II CD20+ Diffuse Large Cell Non-Hodgkin's Lymphoma

National Cancer Institute (NCI)ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

NCI-2012-02957

Secondary identifiers

E3402

OTHER · Eastern Cooperative Oncology Group (ECOG)

U10CA021115

NIH

Study Type

interventional

Actual enrollment (reported)

Locations

1 country

Sites

Timeline

Study Start

December 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2011

Actual (reported)

Study Completion

March 2011

Actual (reported)

Brief Summary

This phase II trial is studying how well giving rituximab together with combination chemotherapy and 90-Yttrium ibritumomab tiuxetan works in treating patients with stage I or stage II lymphoma. Drugs used in chemotherapy, such as prednisone, cyclophosphamide, doxorubicin, and vincristine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab and yttrium 90-Yttrium ibritumomab tiuxetan can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining a monoclonal antibody with combination chemotherapy and a radiolabeled monoclonal antibody may kill more cancer cells.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 62 participants
Study completion date: March 2011
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
August 4, 2004
Actual (reported)
First Posted
August 5, 2004
Actual (reported)
Study Start
December 2004
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
March 2011
Actual (reported)
Study Completion
March 2011
Actual (reported)
Results Posted
February 18, 2015
Actual (reported)

Last Updated: May 25, 2017
Status Verified: April 2017
Results QC Date: February 17, 2015
Last Update Submitted: April 20, 2017

Conditions

Contiguous Stage II Adult Diffuse Large Cell Lymphoma Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Nodal Marginal Zone B-cell Lymphoma Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

Complete Response (CR) +Complete Response/Uncertain (CRu) in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.
Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma (Cheson, 1999). CR is defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms if present prior to therapy, as well as normalization (normal limits of institutional labs) of those biochemical abnormalities (e.g., LDH) definitely attributed to NHL. CRu is defined as meeting the criteria of CR except one or more of the followings: A residual dominant node (or extra-nodal mass) that is currently \> 1.5 cm in greatest diameter that has decreased by \> 75% from baseline in the product of its diameters. Individual dominant nodes (or extra-nodal masses) that were previously confluent must have decreased by \> 75% in SPD compared with the size of the original mass. Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia).
Assessed after 2 cycles of R-CHOP, after completion of R-CHOP, and at Week 12 After 90-Yttrium Zevalin
Functional CR in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.
Patients will be considered a functional CR if they meet the criteria for a CR, or if they meet the criteria for a CRu or partial response (PR) by CT and are PET negative. Please see primary outcome #1 for the definition of CR and CRu. PR is defined as: A decrease of \>50% in the SPD (sum of products of the diameters) of the six largest (or less) dominant nodes or extra-nodal masses. No increase in the size of the liver or the spleen. No unequivocal progression in any non-measurable or non-dominant site. Splenic and hepatic nodules must regress by \>50% in SPD (sum of the products of the diameters). Bone marrow assessment is not relevant for determination of a PR because it is assessable and not measurable disease. No new sites of disease.
Assessed after 2 cycles of R-CHOP, after completion of R-CHOP, and at Week 12 After 90-Yttrium Zevalin

Secondary Outcomes (2)

3-year Time to Treatment Failure (TTF) Rate
Assessed every 3 months for one year; every 4 months for the second year; then every 6 months for 3 years; then annually to 10 years from patient entry.
3-year Overall Survival (OS) Rate
Assessed every 3 months for 2 years, then every 6 months for 3 years; then annually to 10 years from patient entry.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients must have histologically confirmed diagnosis of diffuse large cell lymphoma
Patients must be stage I or II (Modified Ann Arbor staging)
Baseline measurements and evaluations must be obtained within 4 weeks of registration to the study; abnormal PET scans will not constitute evaluable disease unless verified by CT scan or other appropriate imaging; patients must have at least one objective measurable disease parameter (a lesion with at least 1 dimension \> 1.5 cm); or if they are stage 1
Stage I patients must have at least one of the following risk factors:
Age \>= 60 years
Bulky disease (\>= 5 cm in at least one dimension)
Elevated Lactate Dehydrogenase (LDH) above institutional upper limit of normal
Eastern Cooperative Oncology Group (ECOG) performance status = 2
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Absolute neutrophil count \>= 1500/mm\^3 (includes neutrophils and bands)
Platelet count \>= 100,000/mm\^3
Creatinine \< 2.0 mg/dl
Total bilirubin \< 2 mg/dl (may be up to 3.0 mg/dl if due to liver involvement by lymphoma); patients with elevated total bilirubin should have a direct bilirubin checked; if the direct bilirubin is normal there is no need for a dose reduction
Patients must have left ventricular ejection fraction (LVEF) of \> 45%
Patients must be tested for hepatitis B (HBV) surface antigen within 2 weeks of registration
+1 more criteria

You may not qualify if:

Prior chemotherapy, radiation therapy, radioimmunotherapy, or immunotherapy; a short course (=\< 14 days prior to registration) of corticosteroids is allowed
Evidence of other malignancy:
Prior chemotherapy or prior radiation therapy for other malignancies
Currently receiving hormone therapy or chemotherapy for another malignancy even if the treatment is being provided in the adjuvant treatment setting, i.e. with no evidence of the original other malignancy
Adjuvant hormonal therapy must have been discontinued \> 3 months before entering this study

Contact the study team to confirm eligibility.

Rituximab, Combination Chemotherapy, and 90-Yttrium Ibritumomab Tiuxetan for Patients With Stage I or II Non-Hodgkin's Lymphoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (1)

Treatment

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (1)

Treatment

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Locations