NCT00770224|CompletedPhase 2Results

S0801 Iodine I 131 Tositumomab, Rituximab, and Combination Chemotherapy in Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma

A Phase II Study of Iodine-131-Labeled Tositumomab in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients With Advanced Stage Follicular Non-Hodgkin's Lymphoma

SWOG Cancer Research Network ClinicalTrials.gov

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3 other identifiers

CDR0000615104S0801U10CA032102

Study Type

interventional

Target

Locations

1 country

Sites

114

Timeline

RegisteredOct 2008

StartedApr 2009

CompletionAug 2019

Brief Summary

RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving a radiolabeled monoclonal antibody together with rituximab and combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects of giving iodine I 131 tositumomab together with rituximab and combination chemotherapy and to see how well it works in treating patients with previously untreated stage II, stage III, or stage IV follicular non-Hodgkin lymphoma.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P75+ for phase_2 lymphoma

Timeline

Completed

Started Apr 2009

Longer than P75 for phase_2 lymphoma

Geographic Reach

1 country

114 active sites

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

10.3 years study duration

First Submitted

Initial submission to the registry

October 8, 2008

Completed

1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2008

Completed

6 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed

8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed

1.6 years until next milestone

Results Posted

Study results publicly available

November 15, 2018

Completed

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed

Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

8 years

First QC Date

October 8, 2008

Results QC Date

June 27, 2018

Last Update Submit

August 15, 2019

Conditions

Lymphoma

Keywords

contiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphoma

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With 3-year Progression-free Survival (PFS)
Measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is ≥ 50% increase in the sum of products of greatest diameters (SPD) of target measurable nodal lesions over the smallest sum observed (over baseline if no decrease during therapy), or ≥ 50% increase in the greatest transverse diameter (GTD) of any node \> 1 cm in shortest axis, or ≥ 50% increase in the SPD of other target measurable lesions (e.g., splenic or hepatic nodules) over the smallest sum observed. Appearance of any new bone marrow involvement; appearance of a new lesion/site; lymph nodes with the long axis is \> 1.5 cm, or if the both the long and short axes are \> 1 cm; in patients with no pretreatment PET scan or when the PET scan was positive before therapy, lesions should be PET positive; or death due to disease without prior documentation of progression.
0-3 years

Secondary Outcomes (4)

5-year Progression-free Survival
0-5 years
5-year Overall Survival
0-5 years
Response Rate
up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.

Study Arms (1)

R-CHOP, tositumomab and rituximab

EXPERIMENTAL

Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 IV Day 1 Prednisone 100 mg PO Days 1-5 Rituximab 375 mg/m2 IV Day 1 Q 21 Days x 6 Cycles Patients are restaged by CT scan. Unlabeled tositumomab antibody 450 mg IV within 12 after Cycle 6 of CHOP. Dosimetric dose 35 mg IV after infusion of unlabeled tositumomab antibody. Unlabeled tositumomab antibody 450 mg IV 7-14 days after dosimetric dose. Therapeutic dose 35 mg IV after infusion of unlabeled tositumomab antibody. Rituximab 375 mg/m2 IV q 3 months x 4 years beginning 1 year after registration.

Biological: rituximabBiological: tositumomabDrug: cyclophosphamideDrug: doxorubicinDrug: prednisoneDrug: vincristineRadiation: tositumomab