Know Cancer

or
forgot password

Randomized Phase III Study Comparison Between Conventional Chemotherapy and High-Dose Therapy Followed by Autologous Purged Stem-Cell Transplantation in Patients With Follicular Lymphoma Stage III,IV First-Line Treatment for Patients Younger Than 60 Years Old With a High Tumor Burden


Phase 3
18 Years
60 Years
Not Enrolling
Both
Follicular Lymphoma

Thank you

Trial Information

Randomized Phase III Study Comparison Between Conventional Chemotherapy and High-Dose Therapy Followed by Autologous Purged Stem-Cell Transplantation in Patients With Follicular Lymphoma Stage III,IV First-Line Treatment for Patients Younger Than 60 Years Old With a High Tumor Burden


Age 8-60 years old follicular lymphoma Not previously treated Stage II bulky, III or IV An
Arbor classification high tumor burden


Inclusion Criteria:



- Age 18-60 years old

- Follicular Lymphoma B, C or D (Working Formulation)

- No previous treatment

- Seronegativity HIV

- ECOG performance status less than or 2

- eligible for autologous stem-cell transplantation

- Stage II , III or IV Ann Arbor Classification

- criterias of high tumor burden

- Patient's written informed consent

Exclusion Criteria:

- Age less than 18 years old or more than 60 years old

- Other type of lymphoma

- Stage less than 3 or III-IV (faible masse)

- Seropositivity HIV

- Patients with a history of another malignancy except basal cell skin cancer or
in situ uterus cancer

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

event free survival

Outcome Time Frame:

from diagnosis to first event

Safety Issue:

Yes

Principal Investigator

Philippe COLOMBAT, MD PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Authority:

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

Study ID:

GOELAMS 064

NCT ID:

NCT00696735

Start Date:

June 1994

Completion Date:

May 2006

Related Keywords:

  • Follicular Lymphoma
  • Phase III study patients with follicular lymphoma
  • Lymphoma
  • Lymphoma, Follicular

Name

Location