This trial is active, not recruiting.

Condition diffuse large b cell lymphoma
Treatments autologous blood stem transplantation, r-chop (rituximab, cyclphosphamide, etoposide, cisplatin, mesna, g-csf
Sponsor AHS Cancer Control Alberta
Collaborator Hoffmann-La Roche
Start date July 2007
End date August 2011
Trial size 80 participants
Trial identifier NCT00530179, 0307003


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
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)
r-chop (rituximab, cyclphosphamide, etoposide, cisplatin, mesna, g-csf
6 - 21 DAY Cycles of R-CHOP
(Active Comparator)
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.
autologous blood stem transplantation

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title FDG-PET-Stratified R-DICEP and R-BEAM/ASCT For Diffuse Large B-Cell Lymphoma
Principal investigator Douglas Stewart, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in December 2011.
Information provided to ClinicalTrials.gov by AHS Cancer Control Alberta.