NCT00107380|CompletedPhase 2Results

S0433 Iodine I 131 Tositumomab, Rituximab, and Combination Chemotherapy in Treating Older Patients With Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma

Iodine-131-Labeled Monoclonal Anti-B1 Antibody (I-131 Tositumomab) in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients ≥ Age 60 With Advanced Stage Diffuse Large B-Cell NHL: A Phase II Study

SWOG Cancer Research Network ClinicalTrials.gov

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3 other identifiers

CDR0000415955S0433U10CA032102

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredApr 2005

StartedNov 2005

CompletionDec 2015

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 how well giving iodine I 131 tositumomab together with rituximab and combination chemotherapy works in treating older patients with stage II, stage III, or stage IV B-cell non-Hodgkin's 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 Nov 2005

Longer than P75 for phase_2 lymphoma

Geographic Reach

1 country

78 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

10.1 years study duration

First Submitted

Initial submission to the registry

April 5, 2005

Completed

1 day until next milestone

First Posted

Study publicly available on registry

April 6, 2005

Completed

7 months until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed

8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed

3 months until next milestone

Results Posted

Study results publicly available

February 11, 2014

Completed

1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed

Last Updated

March 7, 2016

Status Verified

February 1, 2016

Enrollment Period

8 years

First QC Date

April 5, 2005

Results QC Date

December 23, 2013

Last Update Submit

February 4, 2016

Conditions

Lymphoma

Keywords

contiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomastage III adult diffuse large cell lymphomastage IV adult diffuse large cell lymphoma

Outcome Measures

Primary Outcomes (2)

Progression-free Survival (PFS) at 2 Years
Clinical responses were evaluated according to International Workshop NHL criteria (Cheson et al, 1999). Progression disease was defined as if a (CR, CRU) was not achieved at a previous assessment, a 50% increase in the SPD of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Appearance of a new lesion/site. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Death due to disease without prior documentation of progression. PFS is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
0-2 years
Response Rate (Complete, Complete Unconfirmed, and Partial)
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
6 months

Secondary Outcomes (1)

Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)

Study Arms (1)

R-CHOP x 8 with I-131 Tositumomab

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 Unlabeled Anti-B1 Antibody 450 mg IV Day 170 Dosimetric dose 35 mg IV Day 170 Unlabeled Anti-B1 Antibody 450 mg IV Day 177 Therapeutic dose 35 mg IV Day 177

Biological: rituximabDrug: cyclophosphamideDrug: doxorubicin hydrochlorideDrug: prednisoneDrug: vincristine sulfateRadiation: tositumomab and iodine I 131 tositumomab