MyeloMATCH MSRP: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study
Master Screening and Reassessment Protocol (MSRP) for the NCI MyeloMATCH Clinical Trials
Study Overview
Status
Conditions
Intervention / Treatment
- Drug: Azacitidine
- Procedure: Biospecimen Collection
- Drug: Daunorubicin Hydrochloride
- Drug: Venetoclax
- Drug: Liposome-encapsulated Daunorubicin-Cytarabine
- Procedure: Echocardiography
- Procedure: Multigated Acquisition Scan
- Procedure: Bone Marrow Aspiration and Biopsy
- Procedure: Bone Marrow Aspiration
- Drug: Gilteritinib
- Drug: Cytarabine
- Procedure: Mutation Carrier Screening
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MM1YA-CTG01 Arm I (daunorubicin, cytarabine, venetoclax)
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.
|
Undergo collection of blood samples
Other Names:
Given IV
Other Names:
Given PO
Other Names:
Undergo bone marrow aspiration
Given
Other Names:
|
|
Experimental: MM1YA-CTG01 Arm II (azacitidine, venetoclax)
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.
|
Given IV or SC
Other Names:
Undergo collection of blood samples
Other Names:
Given PO
Other Names:
Undergo bone marrow aspiration
|
|
Active Comparator: MM1YA-CTG01 Arm III (daunorubicin, cytarabine)
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.
|
Undergo collection of blood samples
Other Names:
Given IV
Other Names:
Undergo bone marrow aspiration
Given
Other Names:
|
|
Active Comparator: MM1YA-S01 Arm I (cytarabine, daunorubicin)
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.
|
Undergo collection of blood samples
Other Names:
Given IV
Other Names:
Undergo bone marrow aspiration
Given
Other Names:
|
|
Experimental: MM1YA-S01 Arm II (cytarabine, daunorubicin, venetoclax)
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.
|
Undergo collection of blood samples
Other Names:
Given IV
Other Names:
Given PO
Other Names:
Undergo bone marrow aspiration
Given
Other Names:
|
|
Experimental: MM1YA-S01 Arm III (azacitidine, venetoclax)
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.
|
Given IV or SC
Other Names:
Undergo collection of blood samples
Other Names:
Given PO
Other Names:
Undergo bone marrow aspiration
|
|
Experimental: MM1YA-S01 Arm IV (Vyxeos)
Patients receive Vyxeos IV on study.
Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.
|
Undergo collection of blood samples
Other Names:
Given IV
Other Names:
Undergo bone marrow aspiration
|
|
Active Comparator: MM2YA-EA01 Arm A (cytarabine)
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.
|
Undergo ECHO
Other Names:
Undergo MUGA
Other Names:
Undergo bone marrow aspiration and biopsy
Given
Other Names:
|
|
Experimental: MM2YA-EA01 Arm B (cytarabine, venetoclax)
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.
|
Given PO
Other Names:
Undergo ECHO
Other Names:
Undergo MUGA
Other Names:
Undergo bone marrow aspiration and biopsy
Given
Other Names:
|
|
Experimental: MM2YA-EA01 Arm C (Vyxeos, venetoclax)
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.
|
Given PO
Other Names:
Given IV
Other Names:
Undergo ECHO
Other Names:
Undergo MUGA
Other Names:
Undergo bone marrow aspiration and biopsy
|
|
Experimental: MM2YA-EA01 Arm D (azacitidine, venetoclax)
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.
|
Given IV or SC
Other Names:
Given PO
Other Names:
Undergo ECHO
Other Names:
Undergo MUGA
Other Names:
Undergo bone marrow aspiration and biopsy
|
|
Experimental: Screening (mutation carrier screening)
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.
|
Undergo rapid genetic testing
|
|
Experimental: MM1OA-EA02 Regimen 1 (azacitidine, venetoclax)
INDUCTION: Patients receive azacitidine IV or SC on days 1-7 of each cycle and venetoclax 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. Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial. |
Given IV or SC
Other Names:
Undergo collection of blood samples
Other Names:
Given PO
Other Names:
Undergo bone marrow aspiration and biopsy
|
|
Experimental: MM1OA-EA02 Regimen 2 (azacitidine, venetoclax, gilteritinib)
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. Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial. |
Given IV or SC
Other Names:
Undergo collection of blood samples
Other Names:
Given PO
Other Names:
Undergo bone marrow aspiration and biopsy
Given PO
Other Names:
|
|
Experimental: MM1OA-EA02 Regimen 3 (azacitidine, venetoclax, gilteritinib)
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. Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial. |
Given IV or SC
Other Names:
Undergo collection of blood samples
Other Names:
Given PO
Other Names:
Undergo bone marrow aspiration and biopsy
Given PO
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timing of treatment assignment
Time Frame: Within 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to MDNet generating all data required for treatment assignment
Time Frame: Within 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy
|
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
|
|
Time to treatment assignment
Time Frame: Within 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy
|
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
|
|
Percent assigned to a myeloMATCH clinical trial
Time Frame: Within 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy
|
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
|
|
Percent of screened participants who register to a protocol
Time Frame: Within 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jerald P Radich, SWOG Cancer Research Network
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Bone Marrow Diseases
- Hematologic Diseases
- Myelodysplastic Syndromes
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Protein Kinase Inhibitors
- Antibiotics, Antineoplastic
- Tyrosine Kinase Inhibitors
- Venetoclax
- Azacitidine
- Cytarabine
- Daunorubicin
- Gilteritinib
Other Study ID Numbers
- NCI-2022-07006 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA180888 (U.S. NIH Grant/Contract)
- MYELOMATCH (Other Identifier: CTEP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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