MyeloMATCH MSRP: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study

Acute Myeloid Leukemia Clinical Trial

Official title:

Master Screening and Reassessment Protocol (MSRP) for the NCI MyeloMATCH Clinical Trials

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05564390
• Other study ID #: NCI-2022-07006
• Secondary ID: NCI-2022-07006MY
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 30, 2024
• Est. completion date: May 15, 2029

Study information

• Verified date: May 2024
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This MyeloMATCH Master Screening and Reassessment Protocol (MSRP) evaluates the use of a screening tool and specific laboratory tests to help improve participants' ability to register to clinical trials throughout the course of their myeloid cancer (acute myeloid leukemia or myelodysplastic syndrome) treatment. This study involves testing patients' bone marrow and blood for certain biomarkers. A biomarker (sometimes called a marker) is any molecule in the body that can be measured. Doctors look at markers to learn what is happening in the body. Knowing about certain markers can give doctors more information about what is driving the cancer and how to treat it. Testing patients' bone marrow and blood will show doctors if patients have markers that specific drugs can target. The marker testing in this study will let doctors know if they can match patients with a treatment study (myeloMATCH clinical trial) that tests treatment for the type of cancer they have.

Description:

PRIMARY OBJECTIVE: I. To evaluate the feasibility of MATCHBox generating all data needed for assignment to a myeloMATCH clinical trial or determination that no assignment is available, within 72 hours of MDNet receipt of specimens for initial therapy and within 10 days for subsequent therapy. SECONDARY OBJECTIVES: I. To describe the time to generation of all treatment assignment data, time to treatment assignment, percent assigned to a myeloMATCH clinical trial, and the percent of screened participants who register to a myeloMATCH clinical trial: Ia. For the first Tier 1 myeloMATCH clinical trial assignment; Ib. For Tiers 2, 3, and 4 myeloMATCH clinical trial assignment; Ic. Within each tier of myeloMATCH clinical trials; Id. Within each clinical basket of myeloMATCH clinical trials; Ie. Over time, across and within the categories above. OUTLINE: REGISTRATION: 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. TREATMENT: Patients are assigned to a specific treatment protocol. MM1YA-CTG01: Younger patients (age 18-59 years) with intermediate risk acute myeloid leukemia (AML) are randomized to 1 of 3 arms. ARM I: Patients receive daunorubicin intravenously (IV), cytarabine IV, and venetoclax orally (PO) on study and undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated. ARM II: Patients receive azacitidine IV or subcutaneously (SC) and venetoclax PO on study and undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated. ARM III: 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. MM1YA-S01: Younger patients (age 18-59 years) with high-risk AML are randomized to 1 of 4 arms. ARM I: 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. ARM II: 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. ARM III: 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. ARM IV: Patients receive daunorubicin and cytarabine liposome (Vyxeos) IV on study. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial. MM2YA-EA01: Younger patients (age 18-59 years) with AML or secondary AML who have completed a tier 1 MyeloMATCH treatment study with complete remission (CR) or CR with partial hematologic recovery (CRh) and have detectable minimal residual disease (MRD) (> 0.1%) are randomized to 1 of 4 arms. ARM A: Patients receive cytarabine IV on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo echocardiogram (ECHO) and/or multigated acquisition scan (MUGA) as clinically indicated. ARM B: 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. ARM C: 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. ARM D: 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. MM1OA-EA02: Patients are randomized to 1 of 3 regimens. REGIMEN 1: INDUCTION: Patients receive azacitidine intravenously (IV) or subcutaneously (SC) on days 1-7 and venetoclax orally (PO) on days 1-28 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. REGIMEN 2: INDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax and gilteritinib PO on days 1-28 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days 1-7 and gilteritinib PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. REGIMEN 3: INDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days 1-28, and gilteritinib PO on days 8-21 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days 1-14 and gilteritinib PO on days 8-21 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. All patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 750
• Est. completion date: May 15, 2029
• Est. primary completion date: May 15, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes

Intervention

Drug:
• Azacitidine
Given IV or SC

Procedure:
• Biospecimen Collection
Undergo collection of blood samples
• Bone Marrow Aspiration
Undergo bone marrow aspiration
• Bone Marrow Aspiration and Biopsy
Undergo bone marrow aspiration and biopsy

Drug:
• Cytarabine
Given
• Daunorubicin Hydrochloride
Given IV

Procedure:
• Echocardiography
Undergo ECHO

Drug:
• Gilteritinib
Given PO
• Liposome-encapsulated Daunorubicin-Cytarabine
Given IV

Procedure:
• Multigated Acquisition Scan
Undergo MUGA
• Mutation Carrier Screening
Undergo rapid genetic testing

Drug:
• Venetoclax
Given PO

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timing of treatment assignment	Will evaluate the feasibility of MATCHBox generating all data needed for assignment to a myeloMATCH clinical trial or determination that no assignment is available, within 72 hours of MDNet receipt of specimens for initial therapy and within 10 days for subsequent therapy. For first treatment assignment and separately for each subsequent treatment assignments: every 50 participants for the first 250 participants and then every 100 participants thereafter, the proportion of participants (cumulative and new participants since prior analysis) with all MDNet data need to determine a treatment assignment within 72 hours for first assignment and 10 days for subsequent assignments after the MDNet receives specimens will be tallied.	Within 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy
Secondary	Time to MDNet generating all data required for treatment assignment	Will be assessed for the first (induction) treatment assignment, for post-induction treatment assignment, within each tier of clinical trials, within each clinical basket of clinical trials, and over time (since last report and in 6 months intervals).	Within 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy
Secondary	Time to treatment assignment	Will be assessed for the first (induction) treatment assignment, for post-induction treatment assignment, within each tier of clinical trials, within each clinical basket of clinical trials, and over time (since last report and in 6 months intervals).	Within 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy
Secondary	Percent assigned to a myeloMATCH clinical trial	Will be assessed for the first (induction) treatment assignment, for post-induction treatment assignment, within each tier of clinical trials, within each clinical basket of clinical trials, and over time (since last report and in 6 months intervals).	Within 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy
Secondary	Percent of screened participants who register to a protocol	Will be assessed for the first (induction) treatment assignment, for post-induction treatment assignment, within each tier of clinical trials, within each clinical basket of clinical trials, and over time (since last report and in 6 months intervals).	Within 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy