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
- Conditions
- The study will include newly diagnosed AML patients (other than acute promyelocytic leukemia)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]age 18-60 years, who are eligible for standard induction chemotherapy. The patients will be randomized to one of standard induction regimen (DAC vs. DA-90). Pts with CR will be allocated to consolidation HiDAC with subsequent ASCT or allo SCT acc. to risk of relapse.Pts who do not achieve CR after two induction courses will be randomized to one of standard salvage regimens (FLAG-IDA vs. CLAG-M).
- Registration Number
- EUCTR2017-001308-31-PL
- Lead Sponsor
- Polish Adult Leukaemia Group (PALG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 582
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method