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Role of the Therapy Tailored to Risk Factors in Treating Adult Patients (≤60) With Acute Myeloid Leukemia

NCT02072811 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2014-02-27

No results posted yet for this study

Summary

In view of the diversity of the biology of acute myeloid leukemia (AML) therapy in individual patients must be individualized. One of the tools for this is molecular-cytogenetic stratification. It divides patients into five categories (prognostic groups): Favorable, Intermediate-1, Intermediate-2, Adverse and Very adverse risk. After remission proceedings are tailored depending on prognostic determined groups.

Research of PALG group in the application in the second line regimen CLAG and CLAG-M proved high effectiveness of this treatment with low toxicity. Considering experience of PALG groups, it seems that the use of the schema CLAG early as the second induction therapy is a viable treatment option.

Conditions

Interventions

DRUG

CLAG

* G-CSF 30MU sc, on 0-5 days * Mitoxantrone 10mg/m2 30 min infusion iv, on 1-3 days * Cladribine 5mg/m2 in 2h infusion iv, on 1-5 days * Ara-C 2000mg/m2 4h infusion iv, infusion start after 2h of Cladribine infusion end, on 1-5 day

DRUG

Consolidation, I HAM cycle

* Ara-C 3g/m2; 3h infusion iv every 12h on 1,2,3 days * Mitoxantrone 10mg/m2; 0,5h infusion iv on 3,4,5 days

DRUG

II Consolidation HiDAraC

• Ara-C 3g/m2 every 12h; 3h infusion iv on 1,3,5 days (+ mobilization of CD34+)

DRUG

Consolidation, III HiDAraC cycle

* Ara-C 3g/m2 every 12h; 3h infusion iv on 1,3,5 days * 2-CdA 5 mg/m2 2h infusion iv on 1,3,5 days, 2h before Ara-C

DRUG

DAC

* DNR 60 mg/m2 0,5h infusion iv on 1-3 days * 2-CdA 5 mg/m2 2h. infusion iv on 1-5 days * Ara-C 200 mg/m2 12h infusion iv 2h after end of infusion with 2CdA on 1-7 days

Sponsors & Collaborators

  • Polish Adult Leukemia Group

    collaborator OTHER

  • Copernicus Memorial Hospital

    collaborator OTHER

  • dr hab. n. med. Agnieszka Wierzbowska

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

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 NCT02072811 on ClinicalTrials.gov