Treatment of Aggressive Localized Lymphoma

French Innovative Leukemia Organisation

Status and phase: Terminated; Phase 3

Conditions: B Cell Lymphoma

Treatments: Drug: rituximab; Procedure: radiotherapy; Drug: vincristine; Drug: prednisone; Drug: doxorubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT00841945

GOELAMS 02 03

Details and patient eligibility

About

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.

Full description

CHOP 14 R regimen of chemotherapy is a good standard in the treatment of agressive and localized B lymphoma.

Interest of the radiotheraphy

Enrollment: 334 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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334 participants in 2 patient groups

1

Active Comparator group

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

Treatment:

Drug: doxorubicin

Drug: prednisone

Procedure: radiotherapy

Drug: vincristine

Drug: rituximab

2

Experimental group

Description:

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

Treatment:

Drug: doxorubicin

Drug: prednisone

Drug: vincristine

Drug: rituximab