Study Comparing ABVD vs BEACOPP in Advanced Hodgkin's Lymphoma

Summary

The choice of a preferred first-line treatment requires balancing the desire for optimal disease control with the occurrence of early and late treatment-related effects. To fully assess this balance, the treatment decision process should ideally take into account the outcome following a consistent second-line therapy, in particular when tolerated, widely applicable and highly effective salvage regimens exist, like in Hodgkin lymphoma failing initial chemotherapy.

Conditions

• Hodgkin Lymphoma

Interventions

DRUG

Bleomycin

10 mg/m2 IV day 8 during cycles 1 to 8

DRUG

Etoposide

200 mg/m2 iv on days 1 to 3 during cycles 1 to 4; 100 mg/m2 iv on days 1 to 3 during cycles 5 to 8

DRUG

Doxorubicin

35 mg/2 iv on day 1 during cycles 1 to 4; 25 mg/m2 iv on day 1 during cycles 5 to 8

DRUG

Cyclophosphamide

1250 mg/m2 iv on day 1 during cycles 1 to 4; 650 mg/m2 iv on day 1 during cycles 5 to 8

DRUG

Vincristine

1.4 mg/m2 iv (max 2 mg) on day 8 during cycles 1 to 8

DRUG

Procarbazine

100 mg/m2 po from day 1 to 7 during cycles 1 to 8

DRUG

Prednisone

40 mg/m2 po from day 1 to 14 during cycles 1 to 8

DRUG

Doxorubicin

25 mg/m2 iv on days 1 and 15 in each cycle

DRUG

Bleomycin

10 mg/m2 iv on days 1 and 15 in each cycle

DRUG

Vinblastine

6 mg/m2 iv on days 1 and 15 in each cycle

DRUG

Dacarbazine

375 mg/m2 iv on days 1 and 15 in each cycle

Sponsors & Collaborators

• Fondazione Michelangelo

  lead OTHER

Principal Investigators

• Alessandro M Gianni, MD · Fondazione IRCCS Istituto Nazionale Tumori di Milano

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

17 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2000-03-31

Primary Completion

2009-11-30

Completion

2009-11-30

Countries

• Italy

Study Locations