A Polish Adult Leukemia Group (PALG) prospective, multicenter clinical trial to compare the efficacy of two standard induction and two standard salvage regimens in acute myelogenous leukemia patients = 60 years of age; PALG-AML1/2016

A Polish Adult Leukemia Group (PALG) prospective, multicenter clinical trial to compare the efficacy of two standard induction therapies (DA-90 vs DAC) and two standard salvage regimens (FLAG-IDA vs CLAG-M) in AML patients = 60 years of age - PALG-AML1/2016

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001308-31-PL

Enrollment

582

Registered

2017-04-19

Start date

2017-06-27

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The study will include newly diagnosed AML patients (other than acute promyelocytic leukemia)

Interventions

Pharmaceutical Form: Solution for infusion INN or Proposed INN: cytarabine CAS Number: 147-94-4 Other descriptive name: CYTARABINE Concentration unit: mg/ml milligram(s)/millilitre Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: INDUCTION:1.Acute myelogenous leukemia (=20% of blasts In bone marrow). 2. AML de novo or AML secondary to Myelodysplastic Syndrome or AML secondary to therapies or agents causing leukemia, with primary tumour in remission since at least 2 years. 3. Age =18 - =60 yrs at signing patient’s consent. 4. Clinical status enabling to conduct induction treatment (performance status ECOG = 2, HCT-CI =3 according to Sorror at al. ECOG = 2 HCT-CI =3 according to Sorror at al. REINDUCTION: Resistant or relapsed AML, NR after 1 or 2 cycles of induction, PR after 2 cycles of induction, relapsed at any time of remisssion. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 582 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Promyelocytic leukemia. 2. No patient’s consent. 3. Active neoplastic disease other than AML. 4. Heart diseases, NYHA 3-4. 5. Pregnancy. 6. Uncontrolled infection. 7. Active HIV or HB/CV infection.

Design outcomes

Primary

Measure	Time frame
Main Objective: Assessment of efficacy of two standard induction protocols (DA-90 vs DAC) in newly diagnosed acute myelogenous leukaemia (except of acute promyelocytic leukaemia) by comparison of complete remission rate after 1 and 2 cycles of induction with DA-90 or DAC. 2. Assessment of efficacy of two standard reinduction protocols (CLAG-M vs FLAG-IDA) in resistant and relapsed AML by comparison of complete remission rate after 1 and 2 cycles of reinduction treatment with CLAG-M or FLAG-IDA ;Secondary Objective: 1. Comparison of remission rate without minimal residual disease (MRD) by using immunophenotype method; 2. Overall survival (OS); 3. Progression Free survival (PFS); 4. Relapse rate (RR); 5. Haematologic and non-haematologic toxicity. 6. Extend of supportive treatment (number of erythrocyte units transfusion, number platelets concentrate transfusions and days of hospitalization, economic analysis;Primary end point(s): 1. Complete Remission Rate after 1 and 2 cycles of induction treatment (DA vs DAC). 2. Complete Remission Rate after 1 and 2 cycles of reinduction treatment (CLAG-M vs FLAG-IDA);Timepoint(s) of evaluation of this end point: 1. After 1 and 2 cycle of induction; 2. After 1 and 2 cycle of reinduction.	—

Measure

Time frame

Main Objective: Assessment of efficacy of two standard induction protocols (DA-90 vs DAC) in newly diagnosed acute myelogenous leukaemia (except of acute promyelocytic leukaemia) by comparison of complete remission rate after 1 and 2 cycles of induction with DA-90 or DAC. 2. Assessment of efficacy of two standard reinduction protocols (CLAG-M vs FLAG-IDA) in resistant and relapsed AML by comparison of complete remission rate after 1 and 2 cycles of reinduction treatment with CLAG-M or FLAG-IDA ;Secondary Objective: 1. Comparison of remission rate without minimal residual disease (MRD) by using immunophenotype method; 2. Overall survival (OS); 3. Progression Free survival (PFS); 4. Relapse rate (RR); 5. Haematologic and non-haematologic toxicity. 6. Extend of supportive treatment (number of erythrocyte units transfusion, number platelets concentrate transfusions and days of hospitalization, economic analysis;Primary end point(s): 1. Complete Remission Rate after 1 and 2 cycles of induction treatment (DA vs DAC). 2. Complete Remission Rate after 1 and 2 cycles of reinduction treatment (CLAG-M vs FLAG-IDA);Timepoint(s) of evaluation of this end point: 1. After 1 and 2 cycle of induction; 2. After 1 and 2 cycle of reinduction.

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Remission Rate without minimal residual disease after induction; 2. OS; 3. PFS; 4. Relapse Rate; 5. Hematologic and non-hematologic assessment; 6.Range of supportive treatment;Timepoint(s) of evaluation of this end point: 1. Day 14, day 22-28, after induction, after every cycle of consolidation; 2-6. At the end of the study	—

Countries

Poland

Contacts

Public ContactClinical Trial Information Desk

Haematology Clinic

agawierzbowska@wp.pl48426895167

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026