NCT00530179

Brief Summary

The purpose of this study is to evaluate:

  1. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2007

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2015

Completed
Last Updated

January 22, 2019

Status Verified

January 1, 2019

Enrollment Period

6.6 years

First QC Date

September 13, 2007

Last Update Submit

January 17, 2019

Conditions

Diffuse Large B Cell Lymphoma

Keywords

Diffuse Large B-Cell LymphomaPositron Emission TomographyCHOP Chemotherapy protocolStem Cell TransplantationFluorodeoxyglucose F18

Study Arms (2)

Arm A

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

Drug: R-CHOP

Arm B

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. 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

Interventions

Autologous Blood Stem TransplantationPROCEDURE

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

Arm B
R-CHOPDRUG

6 - 21 DAY Cycles of R-CHOP

Arm A

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Tom Baker Cancer Centre

Calgary, Alberta, T4C 2H5, Canada

Location

Ottawa General Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Saskatchewan Cancer Agency

Regina, Saskatchewan, S7N 4H4, Canada

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

R-CHOP protocol

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Douglas Stewart, M.D.

    AHS Cancer Control Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Douglas Stewart - Principal Investigator

Study Record Dates

First Submitted

September 13, 2007

First Posted

September 17, 2007

Study Start

July 1, 2007

Primary Completion

February 1, 2014

Study Completion

May 19, 2015

Last Updated

January 22, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)