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Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005)

NCT00408278 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2014-10-28

No results posted yet for this study

Summary

Primary objectives

* To evaluate the efficacy and toxicity of a risk-adapted protocol that use idarubicin for induction and consolidation therapy in patients with APL.
* To evaluate the impact of mitoxantrone reduction on the event-free, disease-free, and overall survival, as well as on the duration of remission and cumulative incidence of relapse in low- and intermediate-risk patients with APL.
* To evaluate the impact of the addition of ara-C to idarubicin courses of consolidation for high-risk patients (administered as in the original GIMEMA protocols) on the event-free, disease-free, and overall survival, as well as on the duration of remission and cumulative incidence of relapse.
* To evaluate the toxicity of the induction, consolidation, and maintenance chemotherapy in the whole series and in each treatment group in patients with APL.

Secondary objectives

• To compare all outcomes with those achieved with the PETHEMA LPA99 protocol.

Conditions

  • Acute Promyelocytic Leukemia

Interventions

DRUG

ATRA

45 mg/m2 day until CR Consolidation: 3 cycles (45 mg/m2 days 1-15) Maintenance:15 days every 3 months

DRUG

Idarubicina

Induction: 12 mg/m2 days 2, 4, 6 and 8 Consolidation: 5 mg/m2 days 1-4 in cycle 1 and 12 mg/m2 day 1 in cycle 3.

DRUG

Mitoxantrone

Consolidation: Mitoxantrone 10 mg/m2 days 1-3 in cycle 2

DRUG

ARA-C

In high risk patients, consolidation with ara-C in cycles 1 and 3.

Sponsors & Collaborators

  • PETHEMA Foundation

    lead OTHER

Principal Investigators

  • San Miguel Miguel Angel, Dr · HOSPITAL LA FE VALENCIA

  • Vellenga Edo, Dr · Stichting Hemato-Oncologie voor Volwassenen Nederland

  • Lowenberg Bob, Dr · Stichting Hemato-Oncologie voor Volwassenen Nederland

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2012-04-30
Completion
2013-12-31

Countries

  • Poland
  • Spain
  • Uruguay

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00408278 on ClinicalTrials.gov