FDG-PET-Stratified R-DICEP and R-Beam/ASCT For Diffuse Large B-Cell Lymphoma

This study is ongoing, but not recruiting participants.

First Received on September 13, 2007.  
Last Updated on December 6, 2011  
History of Changes
This Clinical Trial Sponsored By: Alberta Health Services
Collaborator: Hoffmann-La Roche
Information provided by (Responsible Party): Rachel Syme, Alberta Health Services
ClinicalTrials.gov Identifier: NCT00530179
 

Purpose for Clinical Trial

The purpose of this study is to evaluate:

  1. whether an imaging test called a PET (Positron emission tomography) scan performed after two cycles of standard chemotherapy is able to identify patients who have a high cure rate after completing standard chemotherapy alone; and
  2. whether high dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT) when used in combination with an antibody called Rituximab results in high cure rates for those patients predicted to do poorly with standard chemotherapy by the PET scan.

Condition Study Intervention
Diffuse Large B Cell Lymphoma Procedure: Autologous Blood Stem Transplantation
Drug: R-CHOP (Rituximab, Cyclphosphamide, Etoposide, Cisplatin, Mesna, G-CSF

Study Type: Study Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Study Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: FDG-PET-Stratified R-DICEP and R-BEAM/ASCT For Diffuse Large B-Cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics:
Lymphoma
Nuclear Scans
Drug Information available for:
Cisplatin
Mesna
Etoposide
Etoposide phosphate
Rituximab

U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Estimated Enrollment: 80
Study Start Date: July 2007
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Active Comparator: Arm A

Standard R-CHOP chemotherapy every 21 days X 2 Cycles followed by PET/CT scan. If scan is determined negative for disease intensity patient receives 4 more cycles R-CHOP (total 6 cycles R-CHOP)
Drug: R-CHOP (Rituximab, Cyclphosphamide, Etoposide, Cisplatin, Mesna, G-CSF

6 – 21 DAY Cycles of R-CHOP
Active Comparator: Arm B

Standard R-CHOP chemotherapy every 21 days X 2 Cycles followed by PET/CT scan. If scan is determined positive for disease intensity the patient receives one cycle or R-DICEP/R-BEAM the autologous blood stem cell transplantation.
Procedure: Autologous Blood Stem Transplantation

2 CYCLES OF R-CHOP + R-DICEP/R-BEAM FOLLOWED BY AUTOLOGOUS BLOOD STEM CELL TRANSPLANTATION

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-65 years
  • Diagnosis of Diffuse Large B-Cell Lymphoma
  • Adverse Prognosis = Stage 3 or 4 and elevated LDH
  • No more than one prior cycle of R-CHOP chemotherapy
  • Adequate cardiac function
  • No central nervous system involvement by lymphoma

Exclusion Criteria:

  • Histological diagnosis other than Diffuse Large B-cell Lymphoma
  • Pregnant or lactating females
  • Use of other anti-cancer therapies
  • Other serious illness that would compromise study participation
  • Prior malignancy
  • Prior stem cell transplant or radiotherapy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530179

Locations
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T4C 2H5
Canada, Ontario
Ottawa General Hospital
Ottawa, Ontario, Canada, K1H 8L6
Canada, Saskatchewan
Saskatchewan Cancer Agency
Regina, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
Alberta Health Services
Hoffmann-La Roche
Investigators
Principal Investigator: Douglas Stewart, M.D. Alberta Health Services
  More Information

No publications provided

Responsible Party: Rachel Syme, Dr. Douglas Stewart – Principal Investigator, Alberta Health Services
ClinicalTrials.gov Identifier: NCT00530179    
History of Changes
Other Study ID Numbers: 0307003
Study First Received: September 13, 2007
Last Updated: December 6, 2011
Health Authority: Canada: Health Canada

Keywords pr

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