Know Cancer

or
forgot password

Multicentric Study About Treatment of High Grade Peripheral T Cell Lymphoma in Adults. LTP Study Comparison Between VIP ABVD Versus CHOP


Phase 3
18 Years
70 Years
Not Enrolling
Both
Peripheral T Cell Lymphoma

Thank you

Trial Information

Multicentric Study About Treatment of High Grade Peripheral T Cell Lymphoma in Adults. LTP Study Comparison Between VIP ABVD Versus CHOP


Induction therapy:

ARM 1: 6 Chemotherapy courses = 3 VIP alternated with 3 ABVD ARM 2: 8 Chemotherapy courses =
CHOP every 21 days

Consolidation therapy:

For all patients if CR = radiotherapy 40GY / 5X1,8 GY per week


Inclusion Criteria:



- newly diagnosed untreated PTCL

- age 18 and 70 years

- performance status ≤ 2

- Ann Arbor stage I to IV

- normal cardiac ventricular ejection fraction over 50%

- normal hepatic function (asat, ALAT, PAL < 2.5 ULN)

Exclusion Criteria:

- cutaneous form of PTCL

- previous treatment

- age < 18 and > 70

- performance status > 2

- abnormal cardiac or hepatic functions

- HIV-, HCV- or HBV- positivity

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:

Comparison between EFS rate of CHOP/21 versus VIP-rABVD in newly diagnosed PTCL.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Remy GRESSIN, MD MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU Grenoble GOELAMS

Authority:

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

Study ID:

LTP 95

NCT ID:

NCT00970385

Start Date:

January 1995

Completion Date:

September 2008

Related Keywords:

  • Peripheral T Cell Lymphoma
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral

Name

Location