MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat olyan felnőtteket keres, akiknél újonnan felfedezett akut myeloid leukémia (AML) vagy myelodysplasiás szindróma (MDS) gyanúja áll fenn. Csontvelő- és vérvizsgálatokkal osztják be őket egy kezelési vizsgálatba vagy a hagyományos kezelésre.

Életkor

18 éves vagy idősebb

Nem

Bármely nem csatlakozhat

A betegség stádiuma

Gyanítható, még nem kezelt akut myeloid leukémia (AML) vagy myelodysplasiás szindróma (MDS). AML esetén nem lehet korábbi kezelés myeloproliferatív neoplasia (MPN) vagy MDS miatt.

Korábbi kezelés

Nem kaphatott korábban daganatellenes kezelést AML vagy MDS miatt. Hydroxyurea, all-transz retinsav (ATRA), BCR-ABL-gátló tirozinkináz-gátló, vörösvértest-képzést serkentő szer, thrombopoetin-receptor agonista és lenalidomid megengedett, legfeljebb 1 hónapig. Legfeljebb 1 g/m^2 cytarabin megengedett sürgős sejtszámcsökkentésre.

A részvétel fő kizáró okai

• Korábbi daganatellenes kezelés AML vagy MDS miatt
• Másik daganat, amely egyidejű daganatellenes kezelést igényel (a hormonkezelés megengedett)
• Jelenleg cytarabin kezelés, kivéve a sürgős sejtszámcsökkentésre adott legfeljebb 1 g/m^2-t
• Nem hajlandó csontvelő- és vérmintát adni kutatási célra

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

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 or continue standard of care treatment with their doctor on the Tier Advancement Pathway (TAP).

A vizsgálat 30 csoportja

• MM1MDS-A01 Regimen 1 (ASTX727)Már használt kezelés, összehasonlításként

  Patients receive ASTX727 PO QD on days 1-5 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve a CR, CRL, or CRh at the end of cycle 6 may cross-over to Regimen 2. Patients who experience CR, PR, or SD any time after 4 cycles of treatment may be reassessed in order to go to a higher myeloMATCH tier assignment or to TAP. Patients also undergo bone marrow biopsy and aspiration throughout the study. Patients may also undergo optional buccal swab on study, and/or optional additional bone marrow aspiration and blood sample collection on study and at disease progression.

  Kezelés: Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy és Decitabine and Cedazuridine

• MM1MDS-A01 Regimen 2 (ASTX727, enasidenib)A vizsgált kezelés

  Patients receive ASTX727 PO QD on days 1-5 and enasidenib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience CR, PR, or SD any time after 4 cycles of treatment may be reassessed in order to go to a higher myeloMATCH tier assignment or to TAP. Patients also undergo bone marrow biopsy and aspiration throughout the study. Patients may also undergo optional buccal swab on study, and/or optional additional bone marrow aspiration and blood sample collection on study and at disease progression.

  Kezelés: Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Decitabine and Cedazuridine és Enasidenib

• MM1MDS-CTG02 Arm 1 (Luspatercept)A vizsgált kezelés

  Patients receive luspatercept SC on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and blood sample collection throughout the study.

  Kezelés: Biospecimen Collection, Bone Marrow Aspiration és Luspatercept

• MM1MDS-CTG02 Arm 2 (Luspatercept with epoetin alfa)A vizsgált kezelés

  Patients receive luspatercept SC on day 1 and epoetin alfa SC QW for each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and blood sample collection throughout the study.

  Kezelés: Biospecimen Collection, Bone Marrow Aspiration, Epoetin Alfa és Luspatercept

• MM1MDS-CTG02 Arm 3 (Luspatercept and emavusertib)A vizsgált kezelés

  Patients receive luspatercept SC on day 1 and emavusertib PO BID on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and blood sample collection throughout the study.

  Kezelés: Biospecimen Collection, Bone Marrow Aspiration, Emavusertib és Luspatercept

• MM1OA-EA02 Regimen 1 (azacitidine, venetoclax)A vizsgált kezelés

  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 bone marrow assessment shows at least an MLFS response or better ("better" defined as CR, CRi, CRh), 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.

  Kezelés: Azacitidine, Biopsy Procedure, Biospecimen Collection és Venetoclax

• MM1OA-EA02 Regimen 2 (azacitidine, venetoclax, gilteritinib)A vizsgált kezelés

  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 bone marrow assessment shows at least an MLFS response or better ("better" defined as CR, CRi, CRh), 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.

  Kezelés: Azacitidine, Biopsy Procedure, Biospecimen Collection, Gilteritinib és Venetoclax

• MM1OA-EA02 Regimen 3 (azacitidine, venetoclax, gilteritinib)A vizsgált kezelés

  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 bone marrow assessment shows at least an MLFS response or better ("better" defined as CR, CRi, CRh), 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.

  Kezelés: Azacitidine, Biopsy Procedure, Biospecimen Collection, Gilteritinib és Venetoclax

• MM1OA-MDS-A05 Cohort A, Arm 1 (ASTX727, venetoclax)Már használt kezelés, összehasonlításként

  Patients receive ASTX727 PO QD on days 1-5 of each cycle and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR, CRh, or CRi after cycle 4 continue treatment cycles every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow biopsy/aspiration and collection of blood samples throughout the trial.

  Kezelés: Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Decitabine and Cedazuridine és Venetoclax

• MM1OA-MDS-A05 Cohort A,Arm 2 (ASTX727,venetoclax,olutasidenib)A vizsgált kezelés

  Patients receive ASTX727 PO QD on days 1-5 of each cycle, venetoclax PO QD on days 1-28 of each cycle, and olutasidenib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR, CRh, or CRi after cycle 4 continue treatment cycles every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow biopsy/aspiration and collection of blood samples throughout the trial.

  Kezelés: Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Decitabine and Cedazuridine, Olutasidenib és Venetoclax

• MM1OA-MDS-A05 Cohort B, Arm 3 (ASTX727, olutasidenib)A vizsgált kezelés

  Patients receive ASTX727 PO QD on days 1-5 of each cycle and olutasidenib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR continue treatment cycles every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow biopsy/aspiration and collection of blood samples throughout the trial.

  Kezelés: Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Decitabine and Cedazuridine és Olutasidenib

• MM1OA-MDS-A05 Cohort B, Arm 4 (ASTX727)Már használt kezelés, összehasonlításként

  Patients receive ASTX727 PO QD on days 1-5 of each cycle. Cycles repeat every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients without CR after cycle 6 may then cross-over to Arm 3. Patients with CR, as well as patients without CR but deriving clinical benefit after cycle 6 continue treatment cycles every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow biopsy/aspiration and collection of blood samples throughout the trial.

  Kezelés: Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy és Decitabine and Cedazuridine

• MM1OA-MDS-A05 Cohort C (olutasidenib)A vizsgált kezelés

  Patients receive olutasidenib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients deriving clinical benefit after cycle 6 continue treatment cycles every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow biopsy/aspiration and collection of blood samples throughout the trial.

  Kezelés: Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy és Olutasidenib

• MM1OA-S03 Arm 1 (ASTX727, venetoclax)Már használt kezelés, összehasonlításként

  Patients receive ASTX727 PO QD on days 1-5 and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial.

  Kezelés: Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Decitabine and Cedazuridine és Venetoclax

• MM1OA-S03 Arm 2 (ASTX727, venetoclax, enasidenib)A vizsgált kezelés

  Patients receive ASTX727 PO QD on days 1-5, venetoclax PO QD on days 1-28, and enasidenib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial.

  Kezelés: Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Decitabine and Cedazuridine, Enasidenib és Venetoclax

• MM1OA-S04 Arm 1 (ASTX727 with standard duration venetoclax)Már használt kezelés, összehasonlításként

  Patients receive ASTX727 PO QD on days 1-5 and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and blood sample collection throughout the study.

  Kezelés: Biospecimen Collection, Bone Marrow Aspiration, Decitabine and Cedazuridine és Venetoclax

• MM1OA-S04 Arm 2 (ASTX727 with shorter duration venetoclax)A vizsgált kezelés

  Patients receive ASTX727 PO QD on days 1-5 and venetoclax PO QD on days 1-14 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and blood sample collection throughout the study.

  Kezelés: Biospecimen Collection, Bone Marrow Aspiration, Decitabine and Cedazuridine és Venetoclax

• MM1YA-A04 Regimen 1 (gemtuzumab ozogamicin, chemotherapy)Már használt kezelés, összehasonlításként

  Patients receive gemtuzumab ozogamicin IV on day 1, 2 or 3 and on day 4, 5, or 6 (NOTE: two doses must be at least 3 days apart), as well as cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening, as well as bone marrow aspiration and blood sample collection throughout the study.

  Kezelés: Best Practice, Biospecimen Collection, Bone Marrow Aspiration, Cytarabine, Daunorubicin Hydrochloride, Echocardiography Test, Gemtuzumab Ozogamicin és Multigated Acquisition Scan

• MM1YA-A04 Regimen 2 (venetoclax, chemotherapy)A vizsgált kezelés

  Patients receive venetoclax PO QD on days 1-11, cytarabine IV, continuously, on days 2-8 and daunorubicin IV on days 2-4 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration, as well as blood sample collection throughout the study.

  Kezelés: Best Practice, Biospecimen Collection, Bone Marrow Aspiration, Cytarabine, Daunorubicin Hydrochloride, Echocardiography Test, Multigated Acquisition Scan és Venetoclax

• MM1YA-CTG01 Arm I (daunorubicin, cytarabine, venetoclax)A vizsgált kezelés

  Patients receive daunorubicin IV on days 2-4, cytarabine IV continuously on days 2-8, and venetoclax PO QD on days 1-11. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Based on a bone marrow aspiration assessment (completed at the discretion of the treating investigator), patients may receive reinduction consisting of daunorubicin IV on days 2-3, cytarabine IV continuously on days 2-6, and venetoclax PO QD on days 1-8. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated. Additionally, patients undergo ECHO or MUGA during screening.

  Kezelés: Biospecimen Collection, Bone Marrow Aspiration, Cytarabine, Daunorubicin Hydrochloride, Echocardiography Test, Multigated Acquisition Scan és Venetoclax

• MM1YA-CTG01 Arm II (azacitidine, venetoclax)A vizsgált kezelés

  Patients receive azacitidine IV or SC on days 1-7 or days 1-5 and 8-9 and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for a total of 2 cycles, in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated. Additionally, patients undergo ECHO or MUGA during screening.

  Kezelés: Azacitidine, Biospecimen Collection, Bone Marrow Aspiration, Echocardiography Test, Multigated Acquisition Scan és Venetoclax

• MM1YA-CTG01 Arm III (daunorubicin, cytarabine)Már használt kezelés, összehasonlításként

  Patients receive daunorubicin IV on days 1-3 and cytarabine IV, continuously, on days 1-7. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Based on a bone marrow aspiration assessment (completed at the discretion of the treating investigator), patients may receive reinduction consisting of cytarabine IV, continuously, on days 1-5 and daunorubicin IV on days 1-2. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated. Additionally, patients undergo ECHO or MUGA during screening.

  Kezelés: Biospecimen Collection, Bone Marrow Aspiration, Cytarabine, Daunorubicin Hydrochloride, Echocardiography Test és Multigated Acquisition Scan

• MM1YA-EA05 Arm A (cytarabine, daunorubicin, quizartinib)A vizsgált kezelés

  See Detailed Description.

  Kezelés: Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Cytarabine, Daunorubicin, Echocardiography Test, Multigated Acquisition Scan és Quizartinib

• MM1YA-EA05 Arm B (azacitidine, venetoclax, quizartinib)A vizsgált kezelés

  See Detailed Description.

  Kezelés: Azacitidine, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Echocardiography Test, Multigated Acquisition Scan, Quizartinib és Venetoclax

• MM1YA-S01 Arm I (cytarabine, daunorubicin)Már használt kezelés, összehasonlításként

  Patients receive cytarabine IV continuously on days 1-7 and daunorubicin IV on days 1-3 per standard approach of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 1-5 and daunorubicin IV on days 1-2. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.

  Kezelés: Biospecimen Collection, Bone Marrow Aspiration, Cytarabine, Daunorubicin Hydrochloride, Echocardiography Test és Multigated Acquisition Scan

• MM1YA-S01 Arm II (cytarabine, daunorubicin, venetoclax)A vizsgált kezelés

  Patients receive cytarabine IV continuously on days 2-8 and daunorubicin IV on days 2-4 with venetoclax PO on days 1-11 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 2-6 and daunorubicin IV on days 2-3 with venetoclax PO on days 1-8. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.

  Kezelés: Biospecimen Collection, Bone Marrow Aspiration, Cytarabine, Daunorubicin Hydrochloride, Echocardiography Test, Multigated Acquisition Scan és Venetoclax

• MM1YA-S01 Arm III (azacitidine, venetoclax)A vizsgált kezelés

  Patients receive azacitidine SC or IV on days 1-7 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.

  Kezelés: Azacitidine, Biospecimen Collection, Bone Marrow Aspiration, Echocardiography Test, Multigated Acquisition Scan és Venetoclax

• MM1YA-S01 Arm IV (Vyxeos)A vizsgált kezelés

  Patients receive daunorubicin and cytarabine liposome IV over 90 minutes on days 1, 3, and 5 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of daunorubicin and cytarabine liposome IV over 90 minutes on days 1 and 3. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.

  Kezelés: Biospecimen Collection, Bone Marrow Aspiration, Echocardiography Test, Liposome-encapsulated Daunorubicin-Cytarabine és Multigated Acquisition Scan

• MM1YA-S01 Arm V (Vyxeos, venetoclax)A vizsgált kezelés

  Patients receive daunorubicin and cytarabine liposome IV over 90 minutes on days 1, 3, and 5 and venetoclax PO on days 1-14 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of daunorubicin and cytarabine liposome IV over 90 minutes on days 1 and 3 and venetoclax PO on days 1-7. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.

  Kezelés: Biospecimen Collection, Bone Marrow Aspiration, Echocardiography Test, Liposome-encapsulated Daunorubicin-Cytarabine, Multigated Acquisition Scan és Venetoclax

• MM2YA-EA01 Arm A (cytarabine)Már használt kezelés, összehasonlításként

  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.

  Kezelés: Biopsy Procedure, Cytarabine, Echocardiography Test és Multigated Acquisition Scan