Treatment of Aggressive Localized Lymphoma

NCT00841945 | Terminated Phase 3 DMC

• 1 other identifier: GOELAMS 02 03
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

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.

Conditions

B Cell Lymphoma

Keywords

Diffuse B larg cell lymphoma; Chemotherapy; Radiotherapy

Outcome Measures

Primary Outcomes (1)

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

  EFS PFS one year after treatment

Secondary Outcomes (2)

• Pet-scan

  pronostic impact of Pet-scan

• radiotherapy

  Toxicity of the radiotherapy

Study Arms (2)

1

ACTIVE COMPARATOR

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

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

2

EXPERIMENTAL

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

Drug: rituximab; Drug: doxorubicin; Drug: vincristine; Drug: prednisone

Interventions

rituximab DRUG

RITUXIMAB 375 MG/M² IV DAY 1 or each course

Also known as: MABTHERA

1; 2

doxorubicin DRUG

doxorubicin 50 mg / m² iv day 1 of each course

Also known as: Adriblastine

1; 2

vincristine DRUG

VINCRISTINE 1?4 MG/M² IV ON DAY 1

Also known as: Oncovin

1; 2

prednisone DRUG

Prednisone 40 mg/m² DAy 1 to day 5

Also known as: solupred

1; 2

radiotherapy PROCEDURE

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

Also known as: no other name

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• French Innovative Leukemia Organisation: lead

Study Sites (1)

Regional university hospital

Rennes, 35033, France

Location

Related Publications (2)

• 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.

  PMID: 29061568 DERIVED

• 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.

  PMID: 28251914 DERIVED

Related Links

• FILO website

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

Rituximab; Doxorubicin; Vincristine; Prednisone; Radiotherapy

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Therapeutics

Study Officials

• Thierry LAMY, MD PhD

  French Innovative Leukemia Organisation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2009
• First Posted: February 12, 2009
• Study Start: April 1, 2005
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)