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

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00411541
• Other study ID #: I-BFM-SG IR ALL
• Status: Completed
• Phase: Phase 4
• First received: December 13, 2006
• Last updated: December 13, 2006
• Start date: April 1995
• Est. completion date: January 2004

Study information

• Verified date: December 2006
• Source: International BFM Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2600
• Est. completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• vincristine

• dexamethasone

Locations

Country	Name	City	State
Argentina	Department of Pediatric Hematology-Oncology, Italian Hospital	Buenos Aires
Austria	Children's Cancer Research Institute, St Anna Kinderspital	Vienna
Belgium	Department of Pediatric Hemato-Oncology, Gent University Hospital	Gent
Chile	Department of Pediatrics Hematology and Oncology, Hospital Roberto del Rio	Santiago
Czech Republic	Department of Pediatric Hematology and Oncology, University Hospital Motol	Prague
Germany	Medizinische Hochschule Hannover	Hannover
Hungary	Department of Pediatrics, Semmelweis University	Budapest
Italy	Pediatric Clinic - University of Milano-Bicocca	Monza

Sponsors (9)

Lead Sponsor	Collaborator
International BFM Study Group	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, GATLA, Argentina, H-POG, Hungary, PINDA, Chile

Countries where clinical trial is conducted

Argentina,  Austria,  Belgium,  Chile,  Czech Republic,  Germany,  Hungary,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease free survival
Secondary	survival