MyeloMATCH MSRP: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study
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| ClinicalTrials.gov Identifier: NCT05564390 |
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Recruitment Status :
Not yet recruiting
First Posted : October 3, 2022
Last Update Posted : January 17, 2023
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Sponsor:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
National Cancer Institute (NCI)
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Myeloid Leukemia Myelodysplastic Syndrome | Drug: Azacitidine Procedure: Biospecimen Collection Procedure: Bone Marrow Aspiration Procedure: Bone Marrow Aspiration and Biopsy Drug: Cytarabine Drug: Daunorubicin Hydrochloride Procedure: Echocardiography Drug: Liposome-encapsulated Daunorubicin-Cytarabine Procedure: Multigated Acquisition Scan Procedure: Mutation Carrier Screening Drug: Venetoclax | Phase 2 |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 750 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Screening |
| Official Title: | Master Screening and Reassessment Protocol (MSRP) for the NCI MyeloMATCH Clinical Trials |
| Estimated Study Start Date : | February 28, 2023 |
| Estimated Primary Completion Date : | May 12, 2032 |
| Estimated Study Completion Date : | May 12, 2032 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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.
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Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
Procedure: Bone Marrow Aspiration Undergo bone marrow aspiration Drug: Cytarabine Given
Other Names:
Drug: Daunorubicin Hydrochloride Given IV
Other Names:
Drug: Venetoclax Given PO
Other Names:
|
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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.
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Drug: Azacitidine
Given IV or SC
Other Names:
Procedure: Biospecimen Collection Undergo collection of blood samples
Other Names:
Procedure: Bone Marrow Aspiration Undergo bone marrow aspiration Drug: Venetoclax Given PO
Other Names:
|
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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.
|
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
Procedure: Bone Marrow Aspiration Undergo bone marrow aspiration Drug: Cytarabine Given
Other Names:
Drug: Daunorubicin Hydrochloride Given IV
Other Names:
|
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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.
|
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
Procedure: Bone Marrow Aspiration Undergo bone marrow aspiration Drug: Cytarabine Given
Other Names:
Drug: Daunorubicin Hydrochloride Given IV
Other Names:
|
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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.
|
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
Procedure: Bone Marrow Aspiration Undergo bone marrow aspiration Drug: Cytarabine Given
Other Names:
Drug: Daunorubicin Hydrochloride Given IV
Other Names:
Drug: Venetoclax Given PO
Other Names:
|
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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.
|
Drug: Azacitidine
Given IV or SC
Other Names:
Procedure: Biospecimen Collection Undergo collection of blood samples
Other Names:
Procedure: Bone Marrow Aspiration Undergo bone marrow aspiration Drug: Venetoclax Given PO
Other Names:
|
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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.
|
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
Procedure: Bone Marrow Aspiration Undergo bone marrow aspiration Drug: Liposome-encapsulated Daunorubicin-Cytarabine Given IV
Other Names:
|
|
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.
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Procedure: Bone Marrow Aspiration and Biopsy
Undergo bone marrow aspiration and biopsy Drug: Cytarabine Given
Other Names:
Procedure: Echocardiography Undergo ECHO
Other Name: EC Procedure: Multigated Acquisition Scan Undergo MUGA
Other Names:
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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.
|
Procedure: Bone Marrow Aspiration and Biopsy
Undergo bone marrow aspiration and biopsy Drug: Cytarabine Given
Other Names:
Procedure: Echocardiography Undergo ECHO
Other Name: EC Procedure: Multigated Acquisition Scan Undergo MUGA
Other Names:
Drug: Venetoclax Given PO
Other Names:
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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.
|
Procedure: Bone Marrow Aspiration and Biopsy
Undergo bone marrow aspiration and biopsy Procedure: Echocardiography Undergo ECHO
Other Name: EC Drug: Liposome-encapsulated Daunorubicin-Cytarabine Given IV
Other Names:
Procedure: Multigated Acquisition Scan Undergo MUGA
Other Names:
Drug: Venetoclax Given PO
Other Names:
|
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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.
|
Drug: Azacitidine
Given IV or SC
Other Names:
Procedure: Bone Marrow Aspiration and Biopsy Undergo bone marrow aspiration and biopsy Procedure: Echocardiography Undergo ECHO
Other Name: EC Procedure: Multigated Acquisition Scan Undergo MUGA
Other Names:
Drug: Venetoclax Given PO
Other Names:
|
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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.
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Procedure: Mutation Carrier Screening
Undergo rapid genetic testing |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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).
- 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).
- 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).
- 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).
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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).
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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:
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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.
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Participants must not have a prior or concurrent malignancy that requires concurrent anti-cancer therapy
- Note: active hormonal therapy is allowed
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05564390
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Jerald P Radich | SWOG Cancer Research Network |
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT05564390 |
| Other Study ID Numbers: |
NCI-2022-07006 NCI-2022-07006 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) MYELOMATCH ( Other Identifier: SWOG ) MYELOMATCH ( Other Identifier: CTEP ) U10CA180888 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 3, 2022 Key Record Dates |
| Last Update Posted: | January 17, 2023 |
| Last Verified: | September 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page |
| URL: | https://grants.nih.gov/policy/sharing.htm |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Additional relevant MeSH terms:
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Myelodysplastic Syndromes Bone Marrow Diseases Hematologic Diseases Cytarabine Azacitidine Daunorubicin Venetoclax Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Enzyme Inhibitors Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors |