Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-28 @ 2:28 AM
Study NCT ID:
NCT00637832
Status:
TERMINATED
Last Update Posted:
2022-01-06
First Post:
2008-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rituximab, Combination Chemotherapy, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed Follicular Non-Hodgkin Lymphoma
Sponsor:
University of Southampton
Organization:
Study Overview
Official Title:
Short Chemo Radiotherapy in Follicular Lymphoma Trial of 90Y Ibritumomab Tiuxetan (ZevalinTM) as Therapy for First and Second Relapse in Follicular Lymphoma
Status:
TERMINATED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no information
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: