Trial | NCT00869284  Report issue

Title

Long-Term Follow-up of Tandem High-Dose Therapy With Peripheral Blood Stem Cell for Adults With High-Risk Age-Adjusted IPI Aggressive Non-Hodgkin's Lymphomas
Phase II Study Treatment of High Risk Non-Hodgkin's Lymphomas

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    45
Phase II multicenter pilot trial (073) evaluating tandem HDT with PBSC support in aa-IPI=3 untreated aggressive NHL.
High-dose chemotherapy; untreated aggressive non-Hodgkin's lymphoma; high-risk; peripheral blood stem cell support Patients were aged from 15 to 60 years
Study Started
Oct 31
1994
Primary Completion
Jul 31
1999
Study Completion
Feb 28
2009
Last Update
Mar 25
2009
Estimate

Drug CEEP regimen

cyclophosphamide 1200 mg/m² intravenously on day 1 (d1), epirubicin 100 mg/m² intravenously on d1, vindesine 3 mg/m² intravenously on d1 and prednisone 80 mg/m² orally or intravenously on d1-5, with two weeks intervals

Procedure Tandem high-dose therapy (HDT) followed by autologous peripheral blood stem cell (PBSC)

The conditioning regimen of the first HDT was mitoxantrone 45 mg/m² intravenously on d1 + cytarabine 1000 mg/m² by a 3-hour infusion every 12 hours from d1-4. The conditioning regimen of the second HDT started d30 to d45 after the first stem cell infusion, and consisted of 1200 cGy total body irradiation (TBI) in 6 twice daily 200 cGy fractionated doses with a 800 cGy pulmonary shielding, followed by CBV: carmustine 300 mg/m² intravenously on d4, etoposide 200 mg/m² intravenously on d5-8 and cyclophosphamide 1500 mg/m² intravenously on d5-8.

Criteria 

Inclusion Criteria:

patients aged from 15 to 60 years
previously untreated
histologically proven aggressive NHL
high aa-IPI (equal to 3)
proper underlying organ function

Exclusion Criteria:

transformed low-grade, lymphoblastic, mantle-cell, or Burkitt's lymphoma
No Results Posted