Skip to content

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00869284
Acronym
073
Enrollment
45
Registered
2009-03-25
Start date
1994-10-31
Completion date
2009-02-28
Last updated
2009-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

High-dose chemotherapy, aggressive NHL, high-risk, PBSC

Brief summary

Phase II multicenter pilot trial (073) evaluating tandem HDT with PBSC support in aa-IPI=3 untreated aggressive NHL.

Detailed description

High-dose chemotherapy; untreated aggressive non-Hodgkin's lymphoma; high-risk; peripheral blood stem cell support Patients were aged from 15 to 60 years

Interventions

DRUGCEEP 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

PROCEDURETandem 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.

Sponsors

Amgen
CollaboratorINDUSTRY
French Innovative Leukemia Organisation
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Complete responseend of treatment

Secondary

MeasureTime frame
overall survival disease free survival10 years after treatment

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026