Status:
UNKNOWN
A 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 Old
Lead Sponsor:
Polish Adult Leukemia Group
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
The study will include newly-diagnosed AML patients, not suffering acute promyelocytic leukemia; aged 18-60 years, who are eligible for standard induction chemotherapy. The patients will be randomized...
Detailed Description
The successful treatment of acute myeloid leukemia (AML) depends on the ability to achieve complete remission (CR) and to prevent relapse. Both may be affected by the efficacy of induction chemotherap...
Eligibility Criteria
Inclusion
- Diagnosis of acute myeloid leukemia (≥20% of blasts in the bone marrow)
- Previously untreated AML
- AML de novo
- AML secondary to the myelodysplastic syndromes (MDS)
- AML secondary towards used therapies or agents, which can induce leukemia (e.g., irradiation, alkylating drugs, topoisomerase II inhibitors) with a primary tumor in remission for at least 2 years.
- Age ≥ 18 years and ≤60 years while signing a written consent form
- A clinical condition allowing induction treatment to be performed
- General state according to the ECOG ≤ 2 scale (Annex 1)
- Index of comorbidities, HCT-CI ≤ 3, according to Sorror et al. (43) (Annex 2)
- Normal function of the liver and kidneys defined as:
- Bilirubin of ≤1.5 of the upper limit of the normal range
- ALT ≤2.5 x of the upper limit of the normal range
- AST ≤2.5 x of the upper limit of the normal range
- Creatinine ≤1.5 of the upper limit of the normal range
- A negative pregnancy test result in women of reproductive age, or women after menopause
- The patient has understood and signed an informed consent form (Annex 3)
- The patient has given consent to adhere to scheduled appointments in the study and the remaining protocol requirements.
Exclusion
- Diagnosis or suspicion of acute promyelocytic leukemia (APL)
- Lack of consent for participation in the study
- Active cancerous disease other than AML (with the exception of carcinoma basocellulare cutis)
- Diagnosis of unstable angina pectoris, significant cardiac arrhythmia or class III or IV congestive heart failure according to the New York Heart Association (NYHA) functional classification
- Pregnancy
- Uncontrolled mycotic, bacterial or viral systemic infection
- Active HIV, or hepatitis B or C virus infection
- The use of another form of experimental therapy within 28 days of the commencement of treatment
- The presence of another comorbidity or improper study results which could expose the patient to excessive hazard (HCT-CI\>3)
- Any other serious health disorders, abnormal results of laboratory tests or mental disorders which would interfere with participation in the study
- The presence of other comorbidities which would disturb the interpretation of the data obtained in the study.
Key Trial Info
Start Date :
July 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
582 Patients enrolled
Trial Details
Trial ID
NCT03257241
Start Date
July 3 2017
End Date
December 31 2022
Last Update
October 1 2021
Active Locations (10)
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1
Weill Cornell Medicine
New York, New York, United States, 10021
2
Medical University of Bialystok Clinical Hospital
Bialystok, Poland, 15-276
3
Markiewicz Memorial Oncology Center Brzozow
Brzozów, Poland, 36-200
4
University Clinical Centre in Gdansk
Gdansk, Poland, 80-210