Pulses of Vincristine and Dexamethasone in BFM Protocols for Children With Acute Lymphoblastic Leukemia

Summary

Studies in the 1970s and 1980s suggested that the outcome of childhood acute lymphoblastic leukemia could be improved by intensification of conventional continuation chemotherapy with pulses of vincristine sulfate and steroids. We aimed to investigate the efficacy and toxic effects of vincristine-dexamethasone pulses as an addition to the continuation-therapy phase in a large cohort of children with intermediate-risk disease who were treated with the BFM treatment strategy

Conditions

• Acute Lymphoblastic Leukemia

Interventions

DRUG

vincristine

DRUG

dexamethasone

Sponsors & Collaborators

• Associazione Italiana Ematologia Oncologia Pediatrica

  collaborator OTHER

• BFM-A, Austria

  collaborator UNKNOWN

• BFM-G, Germany and Switzerland

  collaborator UNKNOWN

• CPH, Czech republic

  collaborator UNKNOWN

• European Organisation for Research and Treatment of Cancer - EORTC

  collaborator NETWORK

• Group for Acute Leukemia Treatment (GATLA).

  collaborator OTHER

• H-POG (Hungary Pediatric Oncology Group)

  collaborator OTHER

• PINDA, Chile

  collaborator UNKNOWN

• International BFM Study Group

  lead NETWORK

Principal Investigators

• Martin Schrappe, MD · BFM-G, Germany and Switzerland

• Helmut Gadner, MD · BFM-A, Austria

• Giuseppe Masera, MD · AIEOP, Itlay

• Jan Stary, MD · CPH, Czech republic

• Ives Benoit, MD · EORTC-CLG, France, Belgium, Portugal

• Edina Magyarosy, MD · H-POG (Hungary Pediatric Oncology Group)

• Myriam Campbell, MD · PINDA, Chile

• Eduardo Dibar, MD · Group for Acute Leukemia Treatment (GATLA).

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1995-04-30

Completion

2004-01-31

Countries

• Argentina
• Austria
• Belgium
• Chile
• Czechia
• Germany
• Hungary
• Italy

Study Locations