MyeloMATCH MSRP: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study
Acute Myeloid Leukemia, Myelodysplastic Syndrome
About this trial
This is an interventional screening trial for Acute Myeloid Leukemia
Eligibility Criteria
Inclusion Criteria:
- Participants must be suspected to have previously untreated acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). For participants assigned an AML basket protocol, there cannot be a history of previous myeloproliferative neoplasm (MPN) or MDS.
- Participants must be >= 18 years of age.
- Participants must agree to have specimens submitted. Note: Email notification of treatment protocol assignment must be received prior to treatment protocol registration.
- Participants must be offered the opportunity to participate in specimen banking. Note: With participant consent, specimens must be collected and submitted via the Clinical/Correlative Sample Management System (CSMS).
Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.
- Note: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
- The Master Screening and Reassessment Protocol (MSRP) is only used in sites where the relevant AML clinical trials are open. For example, if a site does not have a myeloMATCH tier 1 study for older AML open for enrollment, such older AML patients should not be consented for the MSRP
Exclusion Criteria:
Participants must not have received prior anti-cancer therapy for AML or MDS.
- Note: Hydroxyurea to control the white blood cell count (WBC) is allowed.
Participants must not have a prior or concurrent malignancy that requires concurrent anti-cancer therapy
- Note: active hormonal therapy is allowed
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Experimental
Experimental
Active Comparator
Active Comparator
Experimental
Experimental
Experimental
Active Comparator
Experimental
Experimental
Experimental
Experimental
MM1YA-CTG01 Arm I (daunorubicin, cytarabine, venetoclax)
MM1YA-CTG01 Arm II (azacitidine, venetoclax)
MM1YA-CTG01 Arm III (daunorubicin, cytarabine)
MM1YA-S01 Arm I (cytarabine, daunorubicin)
MM1YA-S01 Arm II (cytarabine, daunorubicin, venetoclax)
MM1YA-S01 Arm III (azacitidine, venetoclax)
MM1YA-S01 Arm IV (Vyxeos)
MM2YA-EA01 Arm A (cytarabine)
MM2YA-EA01 Arm B (cytarabine, venetoclax)
MM2YA-EA01 Arm C (Vyxeos, venetoclax)
MM2YA-EA01 Arm D (azacitidine, venetoclax)
Screening (mutation carrier screening)
Patients receive daunorubicin IV, cytarabine IV, and venetoclax PO on study and undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.
Patients receive azacitidine IV or SC and venetoclax PO on study and undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.
Patients receive daunorubicin IV and cytarabine IV on study and undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.
Patients receive cytarabine IV and daunorubicin IV per standard approach on study. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
Patients receive cytarabine IV and daunorubicin IV with venetoclax PO on study. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
Patients receive azacitidine SC or IV and venetoclax PO on study. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
Patients receive Vyxeos IV on study. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
Patients receive cytarabine IV on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
Patients receive cytarabine IV and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
Patients receive Vyxeos IV and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
Patients receive azacitidine IV or SC and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
Patients undergo bone marrow aspiration and collection of blood on study. Patients' bone marrow and blood specimens undergo rapid genetic testing. Patients are then assigned to a specific protocol containing a therapy targeted to the patient's mutational profile. If there is no targetable mutation, the patient is placed on a protocol testing novel combinations that do not contain a target-specific drug.