Tailoring Treatment for B Cell Non-hodgkin's Lymphoma Based on PET Scan Results Mid Treatment
Recruitment status was Recruiting
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Purpose
The purpose of this study is to assess whether patients who are likely to fail R-CHOP, as predicted by a mid-treatment PET scan, can have an improved outcome if switched to a standard salvage regimen R-ICE (rituximab, ifosfamide, carboplatin, etoposide).
Patients who have a negative PET scan after 4 cycles of R-CHOP have an excellent prognosis (>85% chance of cure) and should complete treatment with 6 cycles of standard R-CHOP. Patients who have a positive PET scan after 4 cycles of R-CHOP have a very poor prognosis (~10% chance of cure) and may have an improved outcome if switched to a non-cross resistant chemotherapy combination R-ICE.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, Non-Hodgkin Advanced Stage Diffuse Large B-Cell Non-Hodgkin's Lymphoma |
Procedure: PET |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial Investigating Tailoring First-Line Therapy For Advanced Stage Diffuse Large B-Cell Non-Hodgkin's Lymphoma Based on Mid-Treatment Positron Emission Tomography (PET) Scan Results |
- efficacy
- progression-free survival (PFS)
- overall survival (OS)
| Estimated Enrollment: | 150 |
| Study Start Date: | August 2006 |
This is a phase II trial investigating tailoring first-line therapy for advanced stage diffuse large B-cell NHL (DLBCL) based on a mid-treatment 18F-FDG- positron-emission tomography (PET) scan result. More than half of all patients with DLBCL can be cured with 6-8 cycles of standard R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone). Patients who are not cured with R-CHOP have a very poor prognosis. This study will assess whether patients who are likely to fail R-CHOP, as predicted by a mid-treatment PET scan, can have an improved outcome if switched to a standard salvage regimen R-ICE (rituximab, ifosfamide, carboplatin, etoposide).
Objectives:
- To assess the efficacy of tailoring first-line therapy based on a mid- treatment PET scan result for patients with advanced stage DLBCL.
- To assess the progression-free survival (PFS) in patients with advanced stage DLBCL who have a negative mid-treatment PET scan and receive standard therapy with six cycles of CHOP-R and patients with a positive mid-treatment PET scan who receive four cycles of CHOP-R followed by four cycles of R-ICE chemotherapy.
- To assess the overall survival (OS) in patients with advanced stage DLBCL who have a negative mid-treatment PET scan and receive standard therapy with six cycles of CHOP-R and patients with a positive mid-treatment PET scan who receive four cycles of CHOP-R followed by four cycles of R-ICE chemotherapy.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 years of age or older
- newly diagnosed histologically proven CD-20 positive diffuse large B- cell lymphoma by tissue biopsy, listed under peripheral B-cell neoplasm according to the WHO/REAL classification (diffuse large B-cell lymphoma, mediastinal large B-cell lymphoma, T-cell rich B-cell lymphoma, intravascular large B-cell lymphoma)
- Advanced stage disease defined as - patients with stage III or stage IV disease; or patients with stage I or stage II disease with one of the following additional criteria: B-symptoms, or disease that is not radio- encompassable within a single involved field, or not a candidate for brief chemotherapy and irradiation, or the presence of bulky disease (any single mass => 10 cm)
- Previously untreated or treated with up to 3 cycles of standard dose 3- weekly R-CHOP chemotherapy prior to enrollment (i.e. patients may be enrolled prior to initiation of the fourth cycle of R-CHOP chemotherapy)
- ECOG Performance Status 0,1 or 2 at time of enrollment
- No evidence of progressive disease while on R-CHOP chemotherapy
- The patient must sign the consent form prior to registration
Exclusion Criteria:
- Patients with a history of any other lymphoproliferative disorder, including prior history of indolent NHL
- Patients with a history of prior or concurrent malignancies within 5 years of the current diagnosis, except adequately treated non- melanoma skin cancer, and curatively treated in-situ cancer of the cervix
- Known HIV infection
- Known hepatitis B virus infection
- Pregnancy or lactation. Men and women of childbearing age must be using adequate contraception.
- Significant renal insufficiency (serum creatinine > 200 mmol/L), unless due to lymphoma
- Significant hepatic insufficiency (serum total bilirubin > 30 mmol/L), unless due to lymphoma
- Cardiac contraindication to doxorubicin therapy (e.g. abnormal contractility on echocardiography). If history of cardiac disease, ejection fraction must be within normal limits for age.
- Neurologic contraindication to vincristine (e.g. peripheral neuropathy)
- Absolute neutrophil count <1.5 x 109/L (unless due to bone marrow involvement with lymphoma or due to initiation of R-CHOP chemotherapy)
- Platelet count < 100 x 109/L (unless due to splenomegaly, bone marrow involvement with lymphoma or due to initiation of R-CHOP chemotherapy)
- Evidence of active systemic infection
- Any medical condition that in the opinion of the investigator would compromise treatment delivery, add toxicity or impair assessment
Contacts and Locations| Contact: Cathy Paul | 604-877-6000 ext 2816 | cpaul@bccancer.bc.ca |
| Canada, British Columbia | |
| BC Cancer Agency | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Contact: Cathy Paul 604-877-6000 ext 2816 cpaul@bccancer.bc.ca | |
| Principal Investigator: Laurie Sehn, MD | |
| Principal Investigator: | Laurie Sehn, MD | BC Cancer Agency - Vancouver Centre |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00324467 History of Changes |
| Other Study ID Numbers: | PET in DLBCL |
| Study First Received: | May 9, 2006 |
| Last Updated: | September 2, 2010 |
| Health Authority: | Canada: Health Canada |
Keywords provided by British Columbia Cancer Agency:
|
NON-HODGKIN'S LYMPHOMA POSITRON EMISSION TOMOGRAPHY |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013