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

• Status: Unknown status
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: dr hab. n. med. Agnieszka Wierzbowska
• Collaborators: Copernicus Memorial Hospital; Polish Adult Leukemia Group, Gliwice, Poland
• Treatments: Cladribine; Cytarabine; Daunorubicin; Lenograstim; Mitoxantrone; Sargramostim

Criteria

Inclusion Criteria:

• Adult acute myeloid leukemia

• Age: ≥18 and ≤ 60

• Clinical condition of the patient allows to carry out induction therapy: ECOG performance status: ≤ 2 and the Hematopoietic Cell Transplant-Co-morbidity Index (HCT-I): ≤3

• Informed consent to participate in the study (ICF signed)

• The second early induction start criteria is in addition to the listed above, the percentage of the blasts on the level >10% on 7th day.

Exclusion Criteria:

• No informed consent for participation in the study, mental illness, which don't allow to obtain informed consent and conduct the treatment according to the protocol

• Pregnancy

• HIV infection

• Active cancer

• Active hepatitis virus infection