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Treatment of Aggressive Localized Lymphoma

Primary Purpose

B Cell Lymphoma

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
rituximab
doxorubicin
vincristine
prednisone
radiotherapy
Sponsored by
French Innovative Leukemia Organisation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B Cell Lymphoma focused on measuring Diffuse B larg cell lymphoma, Chemotherapy, Radiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 18 and < 75 years
  • Diffuse B large cell lymphoma , CD 20+
  • Ann Arbor stage I or II withe a bulk <7 cm
  • stage i ou II confirmed by the PET-scan
  • No previously treated
  • HIV negative
  • Signed Informed consent

Exclusion Criteria:

  • Age< 18 and > 75 years
  • other type of lymphoma
  • CD20 negative
  • Ann Arbor stage >II or bulk > 7 cm
  • HIV positive
  • Contraindication to Rituximab use according to Sm PC
  • Containdication to antracyclin
  • cancer or history of cancer , excepted in situ cancer of the cervix or skin epithelioma
  • Refusal of sign the informed consent

Sites / Locations

  • Regional university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Chemotherapy + Radiotherapy - 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone Radiotherapy 40 gray on initial nodes

Chemotherapy - 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone

Outcomes

Primary Outcome Measures

Event Free Survival (EFS) and Progression Free Survival (PFS)

Secondary Outcome Measures

Pet-scan
radiotherapy

Full Information

First Posted
February 11, 2009
Last Updated
February 20, 2017
Sponsor
French Innovative Leukemia Organisation
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1. Study Identification

Unique Protocol Identification Number
NCT00841945
Brief Title
Treatment of Aggressive Localized Lymphoma
Official Title
Phase III Study of the Interest of Radiotherapy After 4 or 6 Cycles of CHOP 14 Rituximab Regimen of Chemotherapy , Patients With Agressive Localized Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
other drugs other studies
Study Start Date
April 2005 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French Innovative Leukemia Organisation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Prospective and multicentric Phase III study, evaluation of the interest of the radiotherapy after 4 or 6 cycles of CHOP 14 R regimen of chemotherapy , patients with agressive and localized B lymphoma , age 18 to 75 years.
Detailed Description
CHOP 14 R regimen of chemotherapy is a good standard in the treatment of agressive and localized B lymphoma. Interest of the radiotheraphy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B Cell Lymphoma
Keywords
Diffuse B larg cell lymphoma, Chemotherapy, Radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
334 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Chemotherapy + Radiotherapy - 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone Radiotherapy 40 gray on initial nodes
Arm Title
2
Arm Type
Experimental
Arm Description
Chemotherapy - 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone
Intervention Type
Drug
Intervention Name(s)
rituximab
Other Intervention Name(s)
MABTHERA
Intervention Description
RITUXIMAB 375 MG/M² IV DAY 1 or each course
Intervention Type
Drug
Intervention Name(s)
doxorubicin
Other Intervention Name(s)
Adriblastine
Intervention Description
doxorubicin 50 mg / m² iv day 1 of each course
Intervention Type
Drug
Intervention Name(s)
vincristine
Other Intervention Name(s)
Oncovin
Intervention Description
VINCRISTINE 1?4 MG/M² IV ON DAY 1
Intervention Type
Drug
Intervention Name(s)
prednisone
Other Intervention Name(s)
solupred
Intervention Description
Prednisone 40 mg/m² DAy 1 to day 5
Intervention Type
Procedure
Intervention Name(s)
radiotherapy
Other Intervention Name(s)
no other name
Intervention Description
radiotherapy : total dose = 40 GY (5 fractions by week)
Primary Outcome Measure Information:
Title
Event Free Survival (EFS) and Progression Free Survival (PFS)
Time Frame
EFS PFS one year after treatment
Secondary Outcome Measure Information:
Title
Pet-scan
Time Frame
pronostic impact of Pet-scan
Title
radiotherapy
Time Frame
Toxicity of the radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 and < 75 years Diffuse B large cell lymphoma , CD 20+ Ann Arbor stage I or II withe a bulk <7 cm stage i ou II confirmed by the PET-scan No previously treated HIV negative Signed Informed consent Exclusion Criteria: Age< 18 and > 75 years other type of lymphoma CD20 negative Ann Arbor stage >II or bulk > 7 cm HIV positive Contraindication to Rituximab use according to Sm PC Containdication to antracyclin cancer or history of cancer , excepted in situ cancer of the cervix or skin epithelioma Refusal of sign the informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry LAMY, MD PhD
Organizational Affiliation
French Innovative Leukemia Organisation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regional university hospital
City
Rennes
ZIP/Postal Code
35033
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29061568
Citation
Lamy T, Damaj G, Soubeyran P, Gyan E, Cartron G, Bouabdallah K, Gressin R, Cornillon J, Banos A, Le Du K, Benchalal M, Moles MP, Le Gouill S, Fleury J, Godmer P, Maisonneuve H, Deconinck E, Houot R, Laribi K, Marolleau JP, Tournilhac O, Branger B, Devillers A, Vuillez JP, Fest T, Colombat P, Costes V, Szablewski V, Bene MC, Delwail V; LYSA Group. R-CHOP 14 with or without radiotherapy in nonbulky limited-stage diffuse large B-cell lymphoma. Blood. 2018 Jan 11;131(2):174-181. doi: 10.1182/blood-2017-07-793984. Epub 2017 Oct 23.
Results Reference
derived
PubMed Identifier
28251914
Citation
Tout M, Casasnovas O, Meignan M, Lamy T, Morschhauser F, Salles G, Gyan E, Haioun C, Mercier M, Feugier P, Boussetta S, Paintaud G, Ternant D, Cartron G. Rituximab exposure is influenced by baseline metabolic tumor volume and predicts outcome of DLBCL patients: a Lymphoma Study Association report. Blood. 2017 May 11;129(19):2616-2623. doi: 10.1182/blood-2016-10-744292. Epub 2017 Mar 1.
Results Reference
derived
Links:
URL
http://www.filo-leucemie.org
Description
FILO website

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Treatment of Aggressive Localized Lymphoma

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