Tailoring Treatment for B Cell Non-hodgkin’s Lymphoma Based on PET Scan Results Mid Treatment

This study is currently recruiting participants.
Verified September 2010 by British Columbia Cancer Agency

First Received on May 9, 2006.  
Last Updated on September 2, 2010  
History of Changes
This Clinical Trial Sponsored By: British Columbia Cancer Agency
Collaborator: Hoffmann-La Roche
Information provided by: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT00324467
 

Purpose for Clinical Trial

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 Study Intervention Clinical Trial Phase
Lymphoma, Non-Hodgkin
Advanced Stage Diffuse Large B-Cell Non-Hodgkin’s Lymphoma
Procedure: PET Phase 2

Study Type: Study Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics:
Cancer
Lymphoma
Nuclear Scans

U.S. FDA Resources

Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures For Clinical Trial:

  • efficacy

Secondary Outcome Measures For Clinical Trial:

  • progression-free survival (PFS)
  • overall survival (OS)

Estimated Enrollment: 150
Study Start Date: August 2006

Detailed Description:

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
Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324467

Contacts
Contact: Cathy Paul 604-877-6000 ext 2816 cpaul@bccancer.bc.ca

Locations
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            
Sponsors and Collaborators
British Columbia Cancer Agency
Hoffmann-La Roche
Investigators
Principal Investigator: Laurie Sehn, MD BC Cancer Agency – Vancouver Centre

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