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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-10-31

Study Completion Date

2009-02-28

Brief Summary

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

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Detailed Description

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

Conditions

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Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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

Intervention Type DRUG

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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