Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

Launched by BEAT AML, LLC · Jan 5, 2017

Keywords

ClinConnect Summary

This clinical trial is looking at new ways to treat a type of blood cancer called Acute Myeloid Leukemia (AML) in patients who have not received treatment before or those whose cancer has come back after treatment. The researchers want to find out if specific genetic markers in the leukemia cells can help them choose the most effective therapies for each patient. Participants will be screened to see which specific study group they fit into, depending on the genetic features of their cancer. There are different treatment options available based on these findings, with the ultimate goal of developing new targeted therapies for approval.

To be eligible for this trial, participants generally need to be adults aged 60 or older who have either never received treatment for their AML or have experienced a relapse or treatment failure. Those under 60 may also qualify under certain conditions. It’s important that participants can understand and agree to be part of the study. If someone joins, they can expect to undergo tests to determine their specific cancer type and receive personalized treatment based on those results. The trial is currently recruiting participants and is open to all genders. This study represents a promising step towards more tailored treatments for AML, potentially improving outcomes for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults, age 60 years or older at the time of diagnosis unless in a specific known cytogenetic and genomic group for which treatment in Group A or B is allowed by the sub-study where age 18 and older is allowed. Patients \< 60 years old who are screened but do not fall within the cytogenetic and genomic open sub-studies would still be followed on the Master Protocol and not considered screen fails.
• • Subjects must be able to understand and provide written informed consent
• • Cohort Inclusion Criteria - Group A: Subjects must have previously untreated acute myeloid leukemia (AML) according to the WHO classification with no prior treatment other than hydroxyurea. Subjects with blasts % in bone marrow of 10% to 19% or blasts in blood of 10% to 19% will be allowed to enroll to this group. For previously untreated subjects with ≥ 20% blasts in bone marrow or blood only: Prior therapy for myelodysplastic syndrome (MDS), myeloproliferative syndromes (MPD), or aplastic anemia is permitted but not with hypomethylating agents.
• • Cohort Inclusion Criteria - Group B: Subjects must have relapsed or refractory AML according to the WHO classification. For study purposes, refractory AML is defined as failure to ever achieve CR or recurrence of AML within 6 months of achieving CR; relapsed AML is defined as all others with disease after prior remission. For select genomic aberrations specified in the studies, patients ≥ 18 years of age may be allowed to enroll in this portion of the study.
• Exclusion Criteria:
• • Isolated myeloid sarcoma (meaning, patients must have blood or marrow involvement with AML or involved with 10% to 19% blasts to enter the study)
• • Acute promyelocytic leukemia
• • Symptomatic central nervous system (CNS) involvement by AML
• • Signs of leukostasis requiring urgent therapy
• • Disseminated intravascular coagulopathy with active bleeding or signs of thrombosis
• • Patients with psychological, familial, social, or geographic factors that otherwise preclude them from giving informed consent, following the protocol, or potentially hamper compliance with study treatment and follow-up
• • Any other significant medical condition, including psychiatric illness or laboratory abnormality, that would preclude the patient participating in the trial or would confound the interpretation of the results of the trial