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


Phase 4
N/A
17 Years
Not Enrolling
Both
Acute Lymphoblastic Leukemia

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

disease free survival

Principal Investigator

Martin Schrappe, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

BFM-G, Germany and Switzerland

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

I-BFM-SG IR ALL

NCT ID:

NCT00411541

Start Date:

April 1995

Completion Date:

January 2004

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • acute lymphoblastic leukemia, maintenance, BFM protocol
  • intermediate risk childhood acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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