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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00530179
Recruitment Status : Completed
First Posted : September 17, 2007
Last Update Posted : January 22, 2019
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Douglas Stewart, AHS Cancer Control Alberta

Brief Summary:

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 or disease Intervention/treatment Phase
Diffuse Large B Cell Lymphoma Procedure: Autologous Blood Stem Transplantation Drug: R-CHOP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FDG-PET-Stratified R-DICEP and R-BEAM/ASCT For Diffuse Large B-Cell Lymphoma
Study Start Date : July 2007
Actual Primary Completion Date : February 2014
Actual Study Completion Date : May 19, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
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)

Assigned interventions: Drug: R-CHOP (Rituximab, Cyclophosphamide, Etoposide, Cisplatin, Mesna, G-CSF 6 - 21 DAY Cycles of R-CHOP

Drug: R-CHOP
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.

Assigned Interventions: Procedure/Surgery: Autologous Blood Stem Transplantation 2 CYCLES OF R-CHOP + R-DICEP/R-BEAM FOLLOWED BY 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





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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): NCT00530179


Locations
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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
AHS Cancer Control Alberta
Hoffmann-La Roche
Investigators
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Principal Investigator: Douglas Stewart, M.D. AHS Cancer Control Alberta
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Responsible Party: Douglas Stewart, Dr. Douglas Stewart - Principal Investigator, AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00530179    
Other Study ID Numbers: 0307003
First Posted: September 17, 2007    Key Record Dates
Last Update Posted: January 22, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Douglas Stewart, AHS Cancer Control Alberta:
Diffuse Large B-Cell Lymphoma
Positron Emission Tomography
CHOP Chemotherapy protocol
Stem Cell Transplantation
Fluorodeoxyglucose F18
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin