A Randomized Phase Ii Study of Venetoclax and Hma-Based Therapies for the Treatment of Older and Unfit Adults with Newly Diagnosed Flt3-Mutated Acute Myeloid Leukemia (Aml): A Myelomatch Treatment Trial
Study of Investigational Medication for Older Adults with Specific Type of Blood Cancer
Rita Assi
Primary Investigator
Brief description of study
To compare the achievement rate of MRDneg CR of either triplet regimen to azacitidine and venetoclax alone within 4 cycles of therapy
Detailed description of study
In this study, appropriateness for venetoclax and azanucleoside-based therapy
will be determined by the treating physician. Currently, there are no accepted,
validated measures to distinguish patients who are appropriate for intensive vs
non-intensive induction chemotherapy and decisions are largely based on patient
age and physician’s perception of patient fitness. As part of the myeloMATCH
Older Adult AML basket, a comprehensive geriatric assessment will be
implemented across intensive and non-intensive treatment studies to validate
measures of fitness and frailty that predict for treatment-related morbidity and
mortality. The overall goal of the geriatric assessment will be to validate
measures to be incorporated in future older adult AML myeloMATCH studies to
prospectively define “fitness” for intensive chemotherapy.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Acute Myeloid Leukemia (AML), Cancer
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Age: 18 years - 100 years
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Gender: All
Eligibility Criteria
3.1.1 Patient must be ≥ 60 years of age or adults ˂ 60 who in the opinion of
the treating physician are better served by azanucleoside-based
therapy rather than intensive, cytarabine-based induction based on
clinical status (i.e., performance status, age >75 years), organ
dysfunction, or disease biology.
3.1.2 Patient must have a morphologically confirmed diagnosis of AML
according to the WHO 2016 classification excluding APL with PML-
RARA, AML with RUNX1-RUNX1T1, or AML with CBFB-MYH11.
3.1.3 Patient must have no prior therapy for AML with the exception of
hydroxyurea and all-trans retinoic acid (ATRA), or leukapheresis.
Patients with cytarabine-based emergency therapy prior to the start of
therapy on this trial are eligible.
3.1.4 Patient must have no prior therapy with hypomethylating agents or
FLT3 inhibitors.
3.1.5 Patient must have the FLT3-ITD or D835 mutation based on
MyeloMATCH Master Screening and Reassessment Protocol
3.1.6 Patient must be assigned to this protocol by the myeloMATCH MSRP.
3.1.7 Patient must not be pregnant or breast-feeding due to the potential
harm to an unborn fetus and possible risk for adverse events in
nursing infants with the treatment regimens being used.
^^Additional criteria apply and final eligibility will be determined by the study PI.
This study investigates treatments for older adults with a type of blood cancer called acute myeloid leukemia (AML) that has a specific mutation known as FLT3. The purpose is to compare different treatments to see which is more effective. AML is a cancer of the blood and bone marrow, where the body makes abnormal blood cells.
Participants will receive either a combination of investigational medication and other therapies or a standard treatment. The study will observe the response to these treatments over four cycles. A comprehensive assessment will be used to evaluate the fitness of participants for the treatments.
- Who can participate: Adults 60 years or older, or those under 60 deemed suitable by their doctor for azanucleoside-based therapy, can participate. Participants must have a confirmed diagnosis of AML with specific mutations and no prior therapy for AML, except for some exceptions.
- Study details: Participants will receive either investigational medication with other therapies or standard treatment. A comprehensive geriatric assessment will evaluate fitness for treatment.
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