A Phase 2 interventional study of Cytarabine and Venetoclax in Leukemia, Myeloid, Acute, sponsored by Eastern Cooperative Oncology Group. Not yet recruiting. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Eastern Cooperative Oncology Group · Phase 2, Interventional, and Treatment
ERASE is part of the MyeloMATCH initiative, Young Adult Basket and is a Tier 2 study. The study is comparing the use of Cytarabine to Cytarabine and Venetoclax, Daunorubicin/Cytarabine Liposome and Venetoclax, and Azacitidine and Venetoclax.
MM2YA-EA01 is a randomized Phase 2 study. Patients will be randomized to 1 of 4 treatment arms in a 1:1:1:1 ratio. The 4 treatment arms will compare: Cytarabine 3000 mg/m2 for CBD patients/1500 mg/m2 for non-CBD patients to cytarabine 3000 mg/m2 for CBD patients/1500 mg/m2 for non-CBD patients plus venetoclax 100 mg, daunorubicin 29 mg/m2/Cytarabine 65 mg/m2 liposome plus venetoclax 400 mg, and Azacitidine 75 mg/m2 plus venetoclax 400 mg.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 184 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Eastern Cooperative Oncology Group is the lead sponsor of 173 studies on the registry; 7 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Absolute neutrophil count (ANC) ≥ 500/mcL ANC:__________ Date of Test:__________ Platelets ≥ 50,000/mcL Platelets:__________ Date of Test:__________ Total bilirubin ≤ 2 x institutional upper limit of normal (ULN) Total Bilirubin:__________ Institutional ULN:_________ Date of Test:__________ AST(SGOT)/ALT(SGPT) ≤ 3.0 × institutional ULN AST:_______ Institutional ULN:_________ Date of Test:_______ ALT: _______Institutional ULN:_________ Creatinine ≤ 1.5 x institutional ULN Creatinine ______________Date of Test:________ OR
≥ 50 mL/min/1.73 m2
Exclusion Criteria:
All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy.
A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
Patient of child bearing potential? ______ (Yes or No) Date of blood test or urine study: ___________
Patients will participate for 2 cycles. Each cycle is 28 days. For Core Binding Factor (CBF) leukemia patients: Cytarabine 3000 mg/m2 IV twice daily (BID), 12 hours apart x 6 doses either on Days 1, 3, and 5 OR Days 1, 2, and 3 (per institutional preference) For non-Core Binding Factor (CBF) leukemia patients: Cytarabine 1500 mg/m2 IV twice daily (BID), 12 hours apart x 6 either on Days 1, 3, and 5 OR Days 1, 2, and 3 (per institutional preference)
Drug: Cytarabine
Patients will participate for 2 cycles. Each cycle is 28 days. For Core Binding Factor (CBF) leukemia patients: Cytarabine 3000 mg/m2 IV twice daily (BID), 12 hours apart x 6 doses either on Days 1, 3, and 5 OR Days 1, 2, and 3 (per institutional preference) followed by Venetoclax 100 mg daily Day 1 through Day 8 For non-Core Binding Factor (CBF) leukemia patients: Cytarabine 1500 mg/m2 IV twice daily (BID), 12 hours apart x 6 either on Days 1, 3, and 5 OR Days 1, 2, and 3 (per institutional preference) followed by Venetoclax 100 mg daily Day 1 through Day 8
Drug: Cytarabine · Drug: Venetoclax
Patients will participate for 2 cycles. Each cycle is 28 days. Daunorubicin 29 mg/m2/Cytarabine 65 mg/m2 liposome IV on Days 1 and 3 with Venetoclax 400 mg orally once daily on Days 1-14
Drug: Venetoclax · Drug: CPX-351
Patients will participate for 2 cycles. Each cycle is 28 days. Azacitidine 75 mg/m2 IV/SC on Days 1-7 OR Days 1-5 and Days 8-9 (per institutional preference) with Venetoclax 400 mg orally once daily on Days 1-28
Drug: Venetoclax · Drug: Azacitidine
Arm A: CBF-Cytarabine 3000 mg/m2 or 1500 mg/m2 IV twice daily (BID), 12 hours apart x 6 doses either on Days 1, 3, and 5 OR Days 1, 2, and 3
Also known as: 63878
Venetoclax 100 mg daily Day 1 through Day 8 Venetoclax 400 mg orally once daily on Days 1-14 Venetoclax 400 mg orally once daily on Days 1-28
Also known as: Venclexta, 766270
Daunorubicin 29 mg/m2/Cytarabine 65 mg/m2 liposome IV on Days 1 and 3
Also known as: Daunorubicin + Cytarabine Liposome, Vyxeos, 775341
Azacitidine 75 mg/m2 IV/SC on Days 1-7 OR Days 1-5 and Days 8-9 (per institutional preference)
Also known as: Onureg, Vidaza, 102816
Rate of Achieving Minimal residual disease (MRD)
Rate of Achieving MRD Negative CR
Time frame: Day 56
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Eastern Cooperative Oncology Group