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

Status unconfirmed · Phase 3

Conditions studied: Acute Myeloid Leukemia

In brief

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 to one standard induction regimen (DAC or DA-90). At day seven after completion of induction, a bone marrow aspiration with MRD will be performed for an early evaluation of response to treatment. Patients without bone marrow blast reduction below 10% at day seven after induction will be given a second early induction course. Patients who do not achieve CR after two induction courses will be randomized to one of the standard salvage regimens (FLAG-IDA or CLAG-M). Postremission treatment intensity will be adjusted to risk group based on cytogenetic and molecular risk factors at diagnosis and AML biology (secondary AML, therapy related AML). Patients with a low risk of relapse will be allocated to consolidation, with three courses of high doses of Ara-C (HiDAC), or two courses of HiDAC with subsequent autologous stem cell transplantation. Intermediate- or high-risk patients will be referred for allogeneic stem cell transplantation, if they have a matched donor. Until transplantation, consolidation with HiDAC will be continued.

Key facts

Study ID

NCT03257241

Run by

Polish Adult Leukemia Group

People needed

582

Starts

2017-07-03

Expected to finish

2022-12-31

Last updated by the study team

2021-10-01

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Weill Cornell Medicine — New York, New York, United States (enrolling)
• Medical University of Bialystok Clinical Hospital — Bialystok, Poland (enrolling)
• Markiewicz Memorial Oncology Center Brzozow — Brzozów, Poland (enrolling)
• University Clinical Centre in Gdansk — Gdansk, Poland (enrolling)
• Holycross Cancer Center — Kielce, Poland (enrolling)
• Ludwik Rydygier Memorial Specialized Hospital — Krakow, Poland (enrolling)
• Regional Specialised Hospital in Legnica — Legnica, Poland (enrolling)
• Copernicus Memorial Hospital in Lodz Comprehensive Cancer Center and Traumatology — Lodz, Poland (enrolling)
• Independent Public University Hospital No. 1 in Lublin — Lublin, Poland (enrolling)
• Clinical Hospital at the Karol Marcinkowski Medical University in Poznan — Poznan, Poland (enrolling)

Full record on ClinicalTrials.gov

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