Rituximab, Combination Chemotherapy, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed Follicular Non-Hodgkin Lymphoma

Phase 2

Terminated

• Conditions: Lymphoma
• Interventions: Biological: rituximab; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: prednisolone; Drug: vincristine sulfate; Radiation: yttrium Y 90 ibritumomab tiuxetan

• Registration Number: NCT00637832
• Lead Sponsor: University of Southampton

Brief Summary

RATIONALE: 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 work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving rituximab together with combination chemotherapy and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy and yttrium Y 90 ibritumomab tiuxetan works in treating patients with relapsed follicular non-Hodgkin lymphoma.

Detailed Description

OBJECTIVES:

Primary

* To evaluate the response rates in patients with relapsed follicular non-Hodgkin lymphoma treated with short-duration rituximab and combination chemotherapy (R-chemo) followed by rituximab and yttrium Y 90 ibritumomab tiuxetan.

Secondary

* To evaluate the duration of response in patients treated with this regimen.

* To evaluate the quality of response in order to determine the conversion rate from partial response to complete response in patients treated with this regimen.

* To evaluate the toxicity of yttrium Y 90 ibritumomab tiuxetan when administered after 3 courses of R-chemo.

OUTLINE: This is a multicenter study.

* Chemoimmunotherapy (R-CHOP or R-CVP): Patients receive R-CHOP comprising rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisolone on days 1-5. Alternatively, patients who have already been exposed to prior tolerance doses of anthracyclines receive R-CVP comprising rituximab IV, cyclophosphamide IV, and vincristine IV on day 1 and oral prednisolone on days 1-5. Treatment repeats every 3 weeks for up to 3 courses.

Patients with objective evidence of response on CT scan or those with \< 25% bone marrow involvement and no signs of bone marrow hypocellularity (\< 15%) on bone marrow biopsy proceed to radioimmunotherapy.

* Radioimmunotherapy: Four to 6 weeks after completion of R-CHOP or R-CVP, patients receive rituximab IV followed no more than 4 hours later by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes.

After completion of study therapy, patients are followed periodically for up to 5 years.

Study Timeline

• Study First Submitted: 2008-03-14
• Study First Submitted QC: 2008-03-14
• Study First Posted: 2008-03-18
• Study Start: 2008-04-01
• Primary Completion: 2015-01-06
• Study Completion: 2015-01-06
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-16
• Last Update Posted: 2022-01-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single group	rituximab	-
single group	vincristine sulfate	-
single group	doxorubicin hydrochloride	-
single group	yttrium Y 90 ibritumomab tiuxetan	-
single group	prednisolone	-
single group	cyclophosphamide	-

Primary Outcome Measures

Name	Time	Method
Overall response rate, including combined complete response and partial response

Secondary Outcome Measures

Name	Time	Method
Time to disease progression
Time to next treatment
Response duration in patients with responding disease
Safety

Trial Locations

Locations (5)

Mount Vernon Cancer Centre at Mount Vernon Hospital; 🇬🇧 Northwood, England, United Kingdom

Dorset Cancer Centre; 🇬🇧 Poole Dorset, England, United Kingdom

Southampton General Hospital; 🇬🇧 Southampton, England, United Kingdom

Christie Hospital; 🇬🇧 Manchester, England, United Kingdom

Saint Bartholomew's Hospital; 🇬🇧 London, United Kingdom