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NCT Number: NCT00411541

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

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

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Pediatric Hematology-Oncology, Italian Hospital, Buenos Aires, Argentina

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About this study

The study enrols children from 8 participating organizations. All children are treated with similar protocols based on the BFM treatment strategy, which include induction, consolidation, reinduction and continuation-therapy phases. At the beginning of the continuation-therapy phase, those patients in complete remission are randomly assigned to either a treatment or a control group. Control patients are given conventional mercaptopurine and methotrexate chemotherapy only. Patients in the treatment arm are also given pulses of vincristine (1.5 mg/sqm weekly for 2 weeks) and dexamethasone (6 mg/sqm daily for 7 days) every 10 weeks for six cycles.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age <1 or >5 years or
  • white blood cell count at diagnosis >=20000

Exclusion criteria

  • prednisone poor response
  • no complete remission at the end of induction (IA)
  • t(9,22) clonal translocation
  • t(4,11) clonal translocation

Treatment and study plan

Vincristine

Drug

Dexamethasone

Drug

Primary outcomes

  1. disease free survival

Secondary outcomes

  1. survival

Sponsors and collaborators

Lead sponsor

International BFM Study Group

Network

Collaborators

  • Associazione Italiana Ematologia Oncologia Pediatrica
  • BFM-A, Austria
  • BFM-G, Germany and Switzerland
  • CPH, Czech republic
  • European Organisation for Research and Treatment of Cancer - EORTC
  • Group for Acute Leukemia Treatment (GATLA).
  • H-POG (Hungary Pediatric Oncology Group)
  • PINDA, Chile

Registry information

Official study title

Pulses of Vincristine and Dexamethasone During Maintenance in BFM Protocols for Children With Intermediate-Risk Acute Lymphoblastic Leukemia

Important dates

Study start
1995
Study completion
2004
First posted
Dec 14, 2006
Registry last updated
Dec 14, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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