Name | Type | Description | Interventions |
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BAML-16-001-S1 (Closed) | Experimental | This is an open-label Phase 1b/2 clinical study of Samalizumab given in addition to standard induction chemotherapy/consolidation, followed by Samalizumab maintenance, in newly diagnosed acute myeloid leukemia. Patients that are marker negative, as defined based on the Beat AML Master Protocol assignment or with CBF karyotype/interphase cytogenetics/molecular testing defined by presence of t(8;21)(q22;q22) or the molecular equivalent RUNX1/RUNX1T1 fusion transcript or inv(16)(p13q22) or t(16;16)(p13;q22) or the molecular equivalent CBFB/MYH11 fusion transcript based on the Beat AML will receive Samalizumab in combination with induction therapy followed by Samalizumab maintenance. | - Samalizumab (BAML-16-001-S1)
- Daunorubicin (BAML-16-001-S1)
- Cytarabine (BAML-16-001-S1)
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BAML-16-001-S2 | Experimental | This is an open-label Phase 1b/2 clinical study of BI 836858 given in combination with azacitidine, followed by BI 836858 plus azacitidine maintenance, in newly diagnosed acute myeloid leukemia. The target population is assigned by the Beat AML Master Protocol (the "umbrella" study). Eligible patients will have previously untreated acute myeloid leukemia, age greater than or equal to 60, with any 1 of the following: mutated TET2, IDH1, IDH2, or WT1, or "marker negative" as defined by the overall Beat AML umbrella protocol. | - BI 836858 (BAML-16-001-S2)
- Azacitidine (BAML-16-001-S2)
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BAML-16-001-S3 | Experimental | This is a phase 2 clinical trial to assess the feasibility and efficacy of a stepwise approach to the treatment of IDH2-mutant AML. On day 1 of the trial, all enrolled participants will be initiated on therapy with the IDH2 inhibitor AG-221 for IDH2 R140 and R172-mutant patients. The dosing will be based on phase 1 experience of AG-221, which has established 100 mg daily as a safe and tolerated dose, with preliminary suggestion of efficacy. These will be administered continuously in 28 day cycles. Hydroxyurea will be allowed for the purposes of cytoreduction. | - AG-221 (BAML-16-001-S3)
- Azacitidine (BAML-16-001-S3)
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BAML-16-001-S4 (Closed) | Experimental | This is a 2 cohort phase 1b/2 clinical trial to assess the feasibility and efficacy of entospletinib (ENTO) stepwise approach to the treatment of patients with balanced translocations of MLL identified cytogenetically (Cohort 1) and patients with MLL-partial tandem duplications identified molecularly (Cohort 2). All enrolled participants will be initiated on monotherapy with ENTO 400 mg PO BID. This dose will be administered continuously in 28 day cycles. | - Entospletinib (BAML-16-001-S4)
- Azacitidine (BAML-16-001-S4)
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BAML-16-001-S5 | Experimental | This is a phase 2 clinical trial to assess the feasibility and efficacy of a stepwise approach to the treatment of patients with TP53 mutations (identified molecularly) with/without complex karyotype (Cohort A) or complex karyotype (3 or greater metaphase abnormalities without TP53) (Cohort B). All enrolled participants will be initiated on entospletinib 400 mg orally twice daily. This dose will be administered continuously in 28 day cycles. | - Entospletinib (BAML-16-001-S5)
- Decitabine (BAML-16-001-S5)
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BAML-16-001-S6 | Experimental | The study is an open-label phase 2 study of entospletinib in younger and older AML patients with NPM1+/FLT3ITD-AML. It includes patients age ≥18 years who are able and willing to receive 7 + 3 intensive chemotherapy. Entospletinib is administered daily with IV daunorubicin (days 1-3 for Cycle 1) and cytarabine (days 1-7 for Cycle 1). If a second induction is required, it is given with IV daunorubicin (days 1-2 for Cycle 2) and cytarabine (days 1-5 for Cycle 2). | - Entospletinib (BAML-16-001-S6)
- Daunorubicin (BAML-16-001-S6)
- Cytarabine (BAML-16-001-S6)
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BAML-16-001-S9 (Closed) | Experimental | This is an open-label phase 2 clinical trial of a stepwise approach to the treatment of patients with TP53 mutation AML. On day 1, all enrolled participants will be initiated on therapy with pevonedistat (20 mg/m2) day 1, 3 and 5 together with azacitidine (75 mg/m2 days 1-7 or day 1-5 then day 8, 9) every 28 days. During cycle 1, patients with rapidly progressive disease or severe organ dysfunction, not correctable by hydroxyurea cytoreduction will not be eligible to continue. Those patients who achieved a response, defined as complete response or complete response with incomplete blood count recovery, by the end of cycle 4 will continue on pevonedistat and azacitidine until disease progression, unacceptable toxicity, or 12 cycles of therapy. After 12 months of combined therapy, pevonedistat will be continued until progression of disease, unacceptable toxicity, or up to 2 years of total therapy. | - Pevonedistat (BAML-16-001-S9)
- Azacitidine (BAML-16-001-S9)
- AG-120 (BAML-16-001-S16)
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BAML-16-001-S16 | Experimental | This is an open-label phase 2 clinical study to assess the feasibility and efficacy of a combination based approach to the treatment of IDH1 mutant AML. On day 1 of the trial, all enrolled participants will be initiated on therapy with the IDH1 inhibitor AG-120 given daily together with azacitidine (days 1-5 and 8-9 or 7 consecutive days 1-7) in 28 day cycles for IDH1 mutant patients. Those patients who have achieved a response, defined as complete response or complete response with incomplete blood count recovery, by the end of cycle 6, will continue on combination therapy for a total of 12 cycles and then patients will go onto receive monotherapy with AG-120 until disease progression or unacceptable side effects that mandate discontinuation of therapy. Patients who cannot complete 12 cycles of azacitidine may proceed onto monotherapy with AG-120. | - Azacitidine (BAML-16-001-S16)
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BAML-16-001-S8 | Experimental | This is an open-label Phase 2/1b clinical study of gilteritinib as a single agent stratified into 2 cohorts in phase 2 portion based upon dominant versus non-dominant FLT3 mutation status. Cohort 1, Dominant FLT3, will include patients with either FLT3-ITD with allelic ratio of ≥0.5 stratified based upon the prioritization schema of the master trial; FLT3-TKD with highest variant allele frequency among mutations studied for stratification; or FLT3-TKD with second highest variant allele frequency in setting of DNMT3A, TET2, ASXL1, BCORL1, JAK2, and SF3B1 or other spliceosome family member. Cohort 2, non-dominant FLT3, will include the remainder of patients with FLT3-ITD or FLT3-TKD stratified based upon the master umbrella study protocol. For the phase 1b portion, gilteritinib will be given in combination with decitabine for non-responding patients to test the efficacy of gilteritinib in combination with decitabine in elderly AML with FLT3 mutation. | - Gilteritinib (BAML-16-001-S8)
- Decitabine (BAML-16-001-S8)
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