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Front-line High-dose Chemotherapy (HDT) Combined With Rituximab for Adults With Aggressive Large B-cell Lymphoma (DLBCL) : Goelams 074 Trial.


Phase 2
18 Years
60 Years
Not Enrolling
Both
B-Cell Lymphoma

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Trial Information

Front-line High-dose Chemotherapy (HDT) Combined With Rituximab for Adults With Aggressive Large B-cell Lymphoma (DLBCL) : Goelams 074 Trial.


Superiority of HDT with autologous stem cell transplantation (ASCT) in the upfront treatment
of poor-risk DLBCL remains an option for intermediate-high (IH) or high IPI young adults. We
updated results of the prospective trial Goelams 074 to evaluate long-term efficacy and
toxicity in 42 patients who underwent HDT with ASCT.


Inclusion Criteria:



- Age 18 to 60 y.o

- Aggressive Large B-Cell Lymphoma (CD20+)

- Ann Arbor stage III, IV

- IH or high adjusted IPI

- signed inform consent

Exclusion Criteria:

- Age < 18 ou > 60 y.o

- other type of lymphoma

- serology VIH +

- other neoplasms apart from basal cell carcinoma or situ carcinoma

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

CR rate after 3 high dose chemotherapy courses

Outcome Time Frame:

safety/efficacy of chemotherapy treatment

Safety Issue:

Yes

Principal Investigator

Noel MILPIED, PD MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU NANTES/GOELAMS

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

GOELAMS 074

NCT ID:

NCT00965289

Start Date:

April 2002

Completion Date:

June 2009

Related Keywords:

  • B-Cell Lymphoma
  • Aggressive large B-cell lymphoma (DLBCL)
  • Intensive chemotherapy
  • Rituximab
  • ASCT
  • Aggression
  • Lymphoma
  • Lymphoma, B-Cell

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