NCT03336138

Brief Summary

The purpose of this study is to evaluate the value of AMA in a comparative multicenter regional study as a reference for aggressive lymphoma. The primary endpoint will be RDI. This study consider that the AMA support should allow a significant improvement of the RDI compared to the control group and thus impact the duration without progression. The study covers 350 patients recruited from 10 regional centers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for not_applicable lymphoma

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable lymphoma

Geographic Reach
1 country

10 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

January 1, 2012

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

December 15, 2025

Status Verified

April 1, 2019

Enrollment Period

7.1 years

First QC Date

October 30, 2017

Last Update Submit

December 5, 2025

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

  • dose-relative intensity (RDI)

    reduction of RDI

    through study completion, an average of 2 years

Study Arms (2)

AMA group

ACTIVE COMPARATOR

Patient with telephone follow-up modality called AMA (Assistance for ambulatory patients)

Other: AMA (Assistance for ambulatory patients)

Control group

NO INTERVENTION

Patient with standard follow-up with no specific assistance for ambulatory patients

Interventions

AMA (Assistance for ambulatory patients)OTHER

telephone follow-up modality

AMA group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with a recent diffuse large B cell lymphoma (LBDGC), histologically proven, with treatment not started
  • a priori likely to be treated by rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone every 21 days (R-CHOP21) for 8 cycles or rituximab, doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (R-ACVBP).
  • Index international prognosis (IPI) measurable (IPI-aa), adjusted for age. Any IPI-aa is eligible.
  • accepting the study

You may not qualify if:

  • Patient with another type of lymphoma (including transformed follicular forms)
  • Patient having already started his treatment.
  • Life expectancy \<3 months.
  • Carcinologic history
  • Serum positive for HIV or hepatitis B virus (HBV).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University Hospital of Toulouse

Toulouse, France, France

Location

Clinique Claude Bernard

Albi, 81000, France

Location

Hospital

Auch, 32000, France

Location

Bayonne Hospital

Bayonne, 64000, France

Location

University Hospital Bordeaux

Bordeaux, 33000, France

Location

Hospital

Montauban, 82000, France

Location

Clinique Marzet

Pau, 64000, France

Location

Rodez Hospital

Rodez, 12000, France

Location

Tarbes Hospital

Tarbes, 65000, France

Location

Clinique Saint Jean

Toulouse, 31000, France

Location

Related Publications (2)

  • Lamy S, Bettiol C, Grosclaude P, Compaci G, Albertus G, Recher C, Nogaro JC, Despas F, Laurent G, Delpierre C. The care center influences the management of lymphoma patients in a universal health care system: an observational cohort study. BMC Health Serv Res. 2016 Aug 2;16(a):336. doi: 10.1186/s12913-016-1553-9.

    PMID: 27485349RESULT

  • Borel C, Lamy S, Compaci G, Recher C, Jeanneau P, Nogaro JC, Bauvin E, Despas F, Delpierre C, Laurent G. A longitudinal study of non-medical determinants of adherence to R-CHOP therapy for diffuse large B-cell lymphoma: implication for survival. BMC Cancer. 2015 Apr 15;15:288. doi: 10.1186/s12885-015-1287-9.

    PMID: 25884669RESULT

MeSH Terms

Conditions

Lymphoma

Interventions

Insemination, Artificial, Heterologous

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Insemination, ArtificialReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative TechniquesInseminationReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • LAURENT Guy, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 8, 2017

Study Start

January 1, 2012

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

December 15, 2025

Record last verified: 2019-04

Locations

FR(10)