Treatment of Aggressive Localized Lymphoma

Conditions

B Cell Lymphoma

Keywords

Diffuse B larg cell lymphoma, Chemotherapy, Radiotherapy

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

T. Lamy, Gandhi Damaj, Pierre Soubeyran, Emmanuel Gyan, Guillaume Cartron et al. (30 authors)

Blood2017-10-23172 citations

10.1182/blood-2017-07-793984

R‐CHOP +/‐RADIOTHERAPY IN NON‐BULKY LIMITED‐STAGE DIFFUSE LARGE B‐CELL LYMPHOMA (DLBCL): FINAL RESULTS OF THE PROSPECTIVE RANDOMIZED PHASE III 02‐03 TRIAL FROM THE LYSA/GOELAMS

T. Lamy, Gandhi Damaj, Pierre Soubeyran, Emmanuel Gyan, Steven Le Gouill et al. (26 authors)

Hematological Oncology2017-06-016 citations

10.1002/hon.2437_118

Rituximab exposure is influenced by baseline metabolic tumor volume and predicts outcome of DLBCL patients: a Lymphoma Study Association report

Mira Tout, Olivier Casasnovas, Michel Meignan, T. Lamy, Franck Morschhauser et al. (14 authors)

Blood2017-03-0289 citations

10.1182/blood-2016-10-744292

Interventions

DRUGrituximab

RITUXIMAB 375 MG/M² IV DAY 1 or each course

DRUGdoxorubicin

doxorubicin 50 mg / m² iv day 1 of each course

DRUGvincristine

VINCRISTINE 1?4 MG/M² IV ON DAY 1

DRUGprednisone

Prednisone 40 mg/m² DAy 1 to day 5

PROCEDUREradiotherapy

radiotherapy : total dose = 40 GY (5 fractions by week)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Event Free Survival (EFS) and Progression Free Survival (PFS)	EFS PFS one year after treatment

Secondary

Measure	Time frame
Pet-scan	pronostic impact of Pet-scan
radiotherapy	Toxicity of the radiotherapy

Countries

France

Outcome results

None listed