Rituximab, Combination Chemotherapy, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed Follicular Non-Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT00637832|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : March 18, 2008
Last Update Posted : October 7, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisolone Drug: vincristine sulfate Radiation: yttrium Y 90 ibritumomab tiuxetan||Phase 2|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Masking:||None (Open Label)|
|Official Title:||Short Chemo Radiotherapy in Follicular Lymphoma Trial of 90Y Ibritumomab Tiuxetan (ZevalinTM) as Therapy for First and Second Relapse in Follicular Lymphoma|
|Study Start Date :||April 2008|
|Estimated Primary Completion Date :||March 2010|
- Overall response rate, including combined complete response and partial response
- Time to disease progression
- Time to next treatment
- Response duration in patients with responding disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00637832
|Manchester, England, United Kingdom, M20 4BX|
|Contact: Contact Person 44-845-226-3000|
|Mount Vernon Cancer Centre at Mount Vernon Hospital||Recruiting|
|Northwood, England, United Kingdom, HA6 2RN|
|Contact: Contact Person 44-182-382-6111|
|Dorset Cancer Centre||Recruiting|
|Poole Dorset, England, United Kingdom, BH15 2JB|
|Contact: Contact Person 44-120-266-5511|
|Southampton General Hospital||Recruiting|
|Southampton, England, United Kingdom, SO16 6YD|
|Contact: Contact Person 44-238-079-8934 firstname.lastname@example.org|
|Saint Bartholomew's Hospital||Recruiting|
|London, United Kingdom, EC1A 7BE|
|Contact: Contact Person 44-207-377-7000|
|Principal Investigator:||Tim Illidge||The Christie NHS Foundation Trust|