AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT02582775
Drug: Tacrolimus
RxNorm normalized name: Tacrolimus
DrugBank: Tacrolimus (DB00864)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Day +5 through day +100 with goals of 5-10 ug/L (not used for HLA-identical related donors). When used in non-MSD recipients, tapered over 6-8 weeks starting at day +100.
Trial: NCT02582775
Drug: Mycophenolate Mofetil
RxNorm normalized name: Mycophenolate Mofetil
DrugBank: Mycophenolate mofetil (DB00688)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 15 mg/kg IV q8h (based upon actual body weight) with the maximum total daily dose not to exceed 3 grams. Day +5 through day 35
Trial: NCT00394498
Drug: Granulocyte Colony Stimulating Factor
RxNorm normalized name: Granulocyte colony stimulating factor
DrugBank: Filgrastim (DB00099)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Trial: NCT02582775
Drug: Busulfan
RxNorm normalized name: Busulfan
DrugBank: Busulfan (DB01008)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: busulfan IV over 3 hours on days -3 and -2 for HLA-mismatched BM recipients only (Arms F and G)
Trial: NCT02352896
Drug: EPI-743
RxNorm normalized name: 8-epi-cyanocobalamin
DrugBank: 8-epi-Cyanocobalamin (DB14092)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: EPI-743 100 milligrams/milliliter (mg/mL) oral solution will be administered per dose and schedule specified in the arm.
Trial: NCT03969004
Drug: Cemiplimab
RxNorm normalized name: CEMIPLIMAB
DrugBank: Cemiplimab (DB14707)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Intravenous (IV) infusion over 30 minutes
Trial: NCT02023463
Drug: Enzalutamide
RxNorm normalized name: Enzalutamide
DrugBank: Enzalutamide (DB08899)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given PO
Trial: NCT02023463
Drug: Goserelin acetate
RxNorm normalized name: Goserelin Acetate
DrugBank: Goserelin (DB00014)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given SC
Trial: NCT02023463
Drug: Leuprolide acetate
RxNorm normalized name: Leuprolide Acetate
DrugBank: Leuprolide (DB00007)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given IM or SC
Trial: NCT03013998
Drug: Daunorubicin (BAML-16-001-S1)
RxNorm normalized name: daunorubicin
DrugBank: Daunorubicin (DB00694)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 60 mg/m2, IV, on days 4, 5, and 6 of the induction cycle
Trial: NCT03013998
Drug: Cytarabine (BAML-16-001-S1)
RxNorm normalized name: Cytarabine
DrugBank: Cytarabine (DB00987)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 100 mg/m2, IV, on days 4 through 10 of the 24-day induction cycle; 1000 mg/m2, IV, on days 2, 4, and 6 of the consolidation cycle 1 and days 1, 3, and 5 of consolidation cycles 2 through 4
Trial: NCT03013998
Drug: Azacitidine (BAML-16-001-S2)
RxNorm normalized name: Azacitidine
DrugBank: Azacitidine (DB00928)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 75 mg/m2, IV, on days 1 through 7 of each 28-day cycle for 2 years in the absence of toxicity or disease progression
Trial: NCT03013998
Drug: AG-221 (BAML-16-001-S3)
RxNorm normalized name: Bamlanivimab
DrugBank: Bamlanivimab (DB15718)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 100 mg, oral, daily until time of intolerance or disease progression. Dose may be de-escalated to 50 mg based on occurrence of dose-limiting toxicity.
Trial: NCT03013998
Drug: Azacitidine (BAML-16-001-S3)
RxNorm normalized name: Azacitidine
DrugBank: Azacitidine (DB00928)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 75 mg/m2, IV or SC, on days 1 through 7 of each 28-day cycle starting with cycle 6 and ending after 12 cycles for patients not attaining complete remission or complete remission with incomplete blood count recovery after 5 cycles of monotherapy with AG-221
Trial: NCT03013998
Drug: Entospletinib (BAML-16-001-S4)
RxNorm normalized name: Bamlanivimab
DrugBank: Entospletinib (DB12121)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 200 mg, oral, twice daily for 5 years until time of intolerance or disease progression. Dose may be escalated to 400 mg.
Trial: NCT03013998
Drug: Azacitidine (BAML-16-001-S4)
RxNorm normalized name: Azacitidine
DrugBank: Azacitidine (DB00928)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 75 mg/m2, IV or SC, on days 1 through 7 of each 28-day cycle and continuing for 12 cycles. Treatment starts after 1 cycle of monotherapy with entospletinib for patients not attaining complete remission or complete remission with incomplete blood count recovery or after later cycles of monotherapy with entospletinib for patients with disease progression.
Trial: NCT03013998
Drug: Entospletinib (BAML-16-001-S5)
RxNorm normalized name: Bamlanivimab
DrugBank: Entospletinib (DB12121)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 400 mg, oral, twice daily for 2 years on study until time of intolerance or disease progression. Dose may be de-escalated to 200 mg twice daily or 200 mg once daily based on occurrence of dose-limiting toxicity.
Trial: NCT03013998
Drug: Decitabine (BAML-16-001-S5)
RxNorm normalized name: Decitabine
DrugBank: Decitabine (DB01262)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 20 mg/m2, IV, on days 1 through 5 or 10 of each 28-day cycle and continuing for up to 11 cycles. During the first induction cycle, and the 2nd and 3rd induction cycles if they are needed, administration occurs on days 1 through 10 of each 28-day cycle. During subsequent consolidation, decitabine is administered on days 1 through 5 of each 28-day cycle and continuing for up to 11 cycles. Duration may be reduced by 1 day based on occurrence of dose-limiting toxicity, and patients may switch to entospletinib monotherapy maintenance at any time if they develop toxicity or are unwilling to continue decitabine during consolidation therapy.
Trial: NCT00914940
Drug: Fludarabine Phosphate
RxNorm normalized name: Fludarabine Phosphate
DrugBank: Fludarabine (DB01073)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Fludarabine will be administered in a dose of 25 mg/m2/day IV over approximately 30 minutes for 5 consecutive days (day -6 to -2). The total dose of fludarabine will be 125 mg/m2.
Trial: NCT00914940
Drug: Tacrolimus
RxNorm normalized name: Tacrolimus
DrugBank: Tacrolimus (DB00864)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Tacrolimus will be administered beginning on day -1 at a dose of 0.03 mg/kg/day by continuous IV infusion.~For the first cohort of 35 patients, if there is no evidence of grade II-IV acute GVHD on or prior to day 50, tacrolimus should then be tapered at the rate of approximately 5% of the day 50 dose each week for liquid, and 20% of the day 50 dose per month for capsules.~In the second cohort of 25 patients if there is no evidence of grade II GVHD on or prior to day 30, tacrolimus should then be tapered at the rate of approximately 8% of the day 30 dose each week for liquid, and 33% of the day 30 dose per month for capsules.
Trial: NCT03013998
Drug: Entospletinib (BAML-16-001-S6)
RxNorm normalized name: Bamlanivimab
DrugBank: Entospletinib (DB12121)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 400 mg, oral, twice daily for 2 years until time of intolerance or disease progression.
Trial: NCT03013998
Drug: Daunorubicin (BAML-16-001-S6)
RxNorm normalized name: daunorubicin
DrugBank: Daunorubicin (DB00694)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 60 mg/m2, IV, on days 1-3 or 1-2 of each 28-day cycle for the first and second induction cycle, respectively
Trial: NCT03013998
Drug: Cytarabine (BAML-16-001-S6)
RxNorm normalized name: Cytarabine
DrugBank: Cytarabine (DB00987)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 100 mg/m2, IV, on days 1 through 7 or 1 through 5 of each 28-day cycle for the first and second induction cycle, respectively; then 1000 mg/m2 (patients ≥60 years) or 3000 mg/m2 (younger patients with creatinine clearance \>30 mL/min and \<50 mL/min), IV, every 12 hours on days 1, 3, and 5 of each 28-day cycle for up to 4 consolidation cycles
Trial: NCT03013998
Drug: Pevonedistat (BAML-16-001-S9)
RxNorm normalized name: Bamlanivimab
DrugBank: Pevonedistat (DB11759)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 20 mg/m2, IV, on days 1, 3, and 5 of each 28-day cycle and continuing for 24 cycles in the absence of toxicity or disease progression
Trial: NCT03013998
Drug: Azacitidine (BAML-16-001-S9)
RxNorm normalized name: Azacitidine
DrugBank: Azacitidine (DB00928)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 75 mg/m2, IV or SC, on days 1 through 7 or days 1 through 5 and then 8 through 9 (based on institutional guidelines) of each 28-day cycle and continuing for 12 cycles in the absence of toxicity or disease progression
Trial: NCT00914940
Drug: Thiotepa
RxNorm normalized name: Thiotepa
DrugBank: Thiotepa (DB04572)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Thiotepa will be administered in a dose of 5 mg/kg/day (adjusted body weight) IV over approximately 4 hours for 2 consecutive days (day -6 and day -5).
Trial: NCT04155567
Drug: TAK-123
RxNorm normalized name: TAK-243
DrugBank: TAK-243 (DB15013)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TAK-123 infusion
Trial: NCT03013998
Drug: AG-120 (BAML-16-001-S16)
RxNorm normalized name: Bamlanivimab
DrugBank: Bamlanivimab (DB15718)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 500 mg, oral, daily until time of intolerance or disease progression. Dose may be de-escalated to 250 mg based on occurrence of dose-limiting toxicity.
Trial: NCT03013998
Drug: Azacitidine (BAML-16-001-S16)
RxNorm normalized name: Azacitidine
DrugBank: Azacitidine (DB00928)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 75 mg/m2, IV or SC, on days 1 through 7 or days 1 through 5 and then 8 through 9 (based on institutional guidelines) of each 28-day cycle and continuing for 12 cycles in the absence of toxicity or disease progression
Trial: NCT00796367
Drug: VI-0521
RxNorm normalized name: VIS-410
DrugBank: VIS-410 (DB19067)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 7.5 mg phentermine and 46 mg topiramate
Trial: NCT00796367
Drug: VI-0521
RxNorm normalized name: VIS-410
DrugBank: VIS-410 (DB19067)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 15 mg phentermine and 92 mg topiramate
Trial: NCT00617942
Drug: Cohort 1 neo-adjuvant
RxNorm normalized name: phenylephrine
DrugBank: Phenylephrine (DB00388)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Cohort 1 : Trastuzumab 6 mg/kg IV over 60 minutes day -14~Trastuzumab 2 mg/kg IV over 60 minutes weekly then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16
Trial: NCT03013998
Drug: Gilteritinib (BAML-16-001-S8 Group 1)
DrugBank: Gilteritinib (DB12141)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 120 mg, oral, daily, with treatment continuing based on bone marrow results at 28 and 56 days. Patients with partial response at 28 days continue treatment for an additional 28 days. Patients with complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) at 28 or 56 days continue treatment for 5 years until time of intolerance or disease progression. Patients with less than partial response at 28 days or partial response at 28 days followed by less than CR or CRi at 56 days proceed to combination treatment with decitabine or non-study alternative.~The combination dose is 80 mg, oral, daily, for 5 years until time of intolerance or disease progression (patients who do not achieve CR or CRi after 3 cycles will discontinue study treatment). The combination dose may be escalated to 120 mg daily or de-escalated to 80 mg daily given after decitabine rather than in combination with decitabine based on absence or occurrence of dose-limiting toxicity.
Trial: NCT03013998
Drug: Decitabine (BAML-16-001-S8 Group 1)
RxNorm normalized name: Decitabine
DrugBank: Decitabine (DB01262)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 20 mg/m2, IV, on days 1 through 10 of each 28-day cycle and continuing for up to 3 cycles. Treatment starts after 1-2 cycles of monotherapy with gilteritinib if patients do not attain complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) with monotherapy. Patients who do not achieve CR/CRi after 3 cycles of combination therapy will discontinue study treatment. If CR or CRi is obtained with combination therapy after 3 cycles, decitabine will be administered on days 1-5 of each subsequent 28-day cycle until progression, intolerance, or patient desire to discontinue therapy.
Trial: NCT03013998
Drug: AZD5153 (BAML-16-001-S10)
RxNorm normalized name: Bamlanivimab
DrugBank: Bamlanivimab (DB15718)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 20 mg, oral, once daily during 7-day lead-in and then on days 1 through 21 of each 28-day cycle for up to 2 years or until allogeneic stem cell transplantation, time of intolerance, or disease progression \[if the continuous administration AZD5153 on Days 1-21 of a 28-day cycle is not tolerated, an alternative schedule of 2 weeks on and 2 weeks off (i.e. AZD5153 will be administered on Days 1-14 of a 28-day cycle) will be explored\]. Dose may be de-escalated to 10 mg or escalated to 30 mg based on occurrence of dose-limiting toxicity during phase 1 dose escalation. Starting with Cycle 2, patients may receive concomitant fluconazole, isavuconazole, or posaconazole and doses adjusted to 2, 5, or 8 mg daily. The Phase 1b expansion pharmacokinetics cohort will allow for posaconazole starting at Cycle 1 with AZD5153 dose adjusted from 10, 20, or 30 mg daily to 2, 5, or 8 mg daily. Phase 2 dose will be based on Phase 1 results.
Trial: NCT03013998
Drug: Venetoclax (BAML-16-001-S10)
DrugBank: Venetoclax (DB11581)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 400 mg, oral, on days 1 through 21 of each 28-day cycle and continuing for up to 12 cycles (for Cycle 1, day 1 dose will be 100 mg, day 2 dose 200 mg, and days 3 onward 400 mg). Starting with Cycle 2, patients may receive concomitant fluconazole or isavuconazole and daily doses adjusted to 200 mg, or posaconazole and daily doses adjusted to 70 mg. The Phase 1b expansion pharmacokinetics cohort will allow for posaconazole starting at Cycle 1 with Venetoclax dose adjusted to 10 mg on day 1, 20 mg on day 2, 50 mg on day 3, and 70 mg on day 4 onward).
Trial: NCT03013998
Drug: TP-0903 (BAML-16-001-S14)
RxNorm normalized name: OTX-TP
DrugBank: Travoprost (DB00287)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: 37 mg, oral, once daily on days 1 through 21 of each 28-day cycle for up to 2 years to time of intolerance or disease progression. Dose may be de-escalated to as low as 12 mg or escalated to 50 mg based on occurrence of dose-limiting toxicity during Phase 1 dose escalation. Phase 2 dose will be based on Phase 1 results.
Trial: NCT04184921
Drug: Osimertinib 80 MG
RxNorm normalized name: osimertinib 80 MG
DrugBank: Osimertinib (DB09330)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Osimertinib, also known as azd9291, is a 3rd-generation EGFR-TKI used to treat NSCLC patients with resistance to 1st generation EGFR-TKI due to T790M mutation. It has been approved in clinical applications by the FDA in 2015.
Trial: NCT01263652
Drug: orphenadrine
RxNorm normalized name: Orphenadrine
DrugBank: Orphenadrine (DB01173)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: IM/PO orphenadrine
Trial: NCT01263652
Drug: Tramadol
RxNorm normalized name: Tramadol
DrugBank: Tramadol (DB00193)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: IM/PO tramadol
Trial: NCT01263652
Drug: Dipyrone
RxNorm normalized name: Dipyrone
DrugBank: Metamizole (DB04817)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: PO/IM Dipyrone
Trial: NCT02223208
Drug: Ro-CHOEP-21 (PHASE I)
RxNorm normalized name: RO-5045337
DrugBank: RO-5045337 (DB14793)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Romidepsin (dose escalation) Starting dose: 12mg/ms iv day +1 and +8~Dose modification according to toxicity:~* 14mg/ms day +1 and +8~* 10mg/ms day +1 and +8~* 8mg/ms day +1 and +8~CHOEP-21~* Doxorubicin 50 mg/ms iv day +1 or +2,~* Vincristin 1.4 mg/ms (maximum 2.0 mg total dose) iv day+1 or +2~* Cyclophosphamide 750 mg/ms iv day +1 or +2~* Etoposide 100mg/ms iv from day +1 to +3 or from day +2 to +4~* Prednisone100 mg orally from days +1 to +5 or from days +2 to +6~PR or CR:Ro-CHOEP-21 for 3 additional cycles followed by stem cell mobilization and transplantation phase (CR --\> AUTO-SCT, PR --\> ALLO-SCT)
Trial: NCT02223208
Drug: Ro-CHOEP-21 (PHASE II)
RxNorm normalized name: RO-5045337
DrugBank: RO-5045337 (DB14793)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Ro-CHOEP-21 x 3 cycles~* Romidepsin dose according to phase I iv day +1 and +8~* Doxorubicin 50 mg/ms iv day +1 or +2,~* Vincristin 1.4 mg/ms (maximum 2.0 mg total dose) iv day+1 or +2,~* Cyclophosphamide 750 mg/ms iv day +1 or +2~* Etoposide 100mg/ms iv from day +1 to +3 or from day +2 to +4~* Prednisone100 mg orally from days +1 to +5 or from days +2 to +6~PR or CR: Ro-CHOEP-21 for 3 additional cycles followed by stem cell mobilization and transplantation phase (CR --\> AUTO-SCT, PR --\> ALLO-SCT)
Trial: NCT03013998
Drug: Decitabine (BAML-16-001-S14)
RxNorm normalized name: Decitabine
DrugBank: Decitabine (DB01262)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 20 mg/m2, IV, on days 1 through 5 or 10 of each 28-day cycle and continuing for up to 2 years to time of intolerance or disease progression. During the first induction cycle, and the 2nd and 3rd induction cycles if they are needed, administration occurs on days 1 through 10 of each 28-day cycle. During maintenance, decitabine is administered on days 1 through 5 of each 28-day cycle. Patients may switch to TP-0903 monotherapy maintenance if they develop toxicity or are unwilling to continue decitabine during maintenance therapy.
Trial: NCT03013998
Drug: Decitabine (BAML-16-001-S8 Group 2)
RxNorm normalized name: Decitabine
DrugBank: Decitabine (DB01262)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 20 mg/m2, IV, on days 8 through 12 of the first 35-day induction cycle, then on days 1 through 5 of subsequent 28-day cycles and continuing for up to 60 cycles, disease progression, intolerance, or patient desire to discontinue therapy.
Trial: NCT03013998
Drug: Venetoclax (BAML-16-001-S8 Group 2)
DrugBank: Venetoclax (DB11581)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Oral dosing based on concurrent antifungal use. Dose without use of concomitant antifungal is 400mg, dose if on posaconazole is 70mg, dose if on voriconazole is 100mg, and dose if on moderate CYP3A inhibitors (ie fluconazole, isavuconazole) is 200mg continuing for up to 12 total cycles. For the 35-day induction cycle 1, dosing is days 2 through 28. For the 28-day induction cycle 2, if needed, dosing is days 1 through 21. For the 28-day consolidation cycles, dosing is days 1-15.
Trial: NCT03013998
Drug: AZD5991 (BAML-16-001-S18)
RxNorm normalized name: Bamlanivimab
DrugBank: Bamlanivimab (DB15718)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 150 mg, IV, on days 1, 4, 8, 11, 15, and 18 of three 28-day cycles; followed by 150 mg/m2, IV, on days 1, 4, 8, and 11 of twenty-one 28-day cycles; followed by 150 mg/m2 on days 1 and 4 of each 28-day cycle until time of progression, unacceptable toxicity, death, or 57 total cycles of treatment. Dose may be escalated to a maximum dose of 400 mg or de-escalated to 100 mg based on occurrence of dose-limiting toxicity.
Trial: NCT03013998
Drug: Azacitidine (BAML-16-001-S18)
RxNorm normalized name: Azacitidine
DrugBank: Azacitidine (DB00928)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 75 mg/m2, IV or SC, on days 1-7 or days 1-5 and 8 and 9 or days 1-2 and 5-9 (based on institutional guidelines) of each 28-day cycle until time of progression, unacceptable toxicity, death, or 57 total cycles of treatment
Trial: NCT03013998
Drug: SNDX-5613 (BAML-16-001-S17)
RxNorm normalized name: Bamlanivimab
DrugBank: Bamlanivimab (DB15718)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 113 mg, oral, every 12 hours on Day 1-28 of each 28-day cycle, until time of progression, unacceptable toxicity, or death. Dose may be escalated to a maximum dose of 163 mg on days 1-28 or de-escalated to 113 mg on days 1-21 based on occurrence of dose-limiting toxicity. Other possible dose escalation and de-escalation would be 163 mg on days 1-21, 75 mg on days 1-21 and 75 mg on days 1-28. Following completion of induction, patients who do not require strong CYP3A4 inhibitor antifungals will have daily doses increased for doses in range of 113-226 mg (days 1-21 or days 1-28).
Trial: NCT03013998
Drug: Azacitidine (BAML-16-001-S17)
RxNorm normalized name: Azacitidine
DrugBank: Azacitidine (DB00928)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 75 mg/m2, IV or SC, on days 1-7 (during induction cycle/cycles) or can use alternative scheduled on days 1-5 and 8 and 9 or days 1-2 and 5-9 (based on institutional guidelines) during continued therapy cycles of each 28-day cycle until time of progression, unacceptable toxicity, or death.
Trial: NCT02801487
Drug: Cisplatin
RxNorm normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Cisplatin (40mg/m\^2) monotherapy will be given weekly along with radiotherapy.
Trial: NCT03013998
Drug: Venetoclax (BAML-16-001-S17)
DrugBank: Venetoclax (DB11581)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: For Cycle 1 induction, day 1 dose is 10 mg, day 2 dose 20 mg, day 3 dose is 50 mg, and day 4 onward dose is 100 mg or 70 mg depending on concomitant antifungal treatment. For Cycles 2 and 3 inductions, daily doses are 100 or 70 mg depending on concomitant antifungal treatment. During continued therapy cycles, if not on concomitant strong CYP3A4 inhibitor antifungals, 400 mg, oral, on days 1 through 28 or days 1 through 14 of each 28-day cycle until time of progression, unacceptable toxicity, or death (patients on moderate CYP3A4 inhibitor antifungals should receive 200 mg/day).
Trial: NCT03013998
Drug: Gilteritinib (BAML-16-001-S8 Group 2)
DrugBank: Gilteritinib (DB12141)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Phase 1b induction: 80-120 mg, oral, daily for day 1 up to day 28 of the 35-day induction cycle 1; then 80-120 mg, oral, daily for day 1 up to day 28 of the 28-day induction cycle 2 (induction cycle 2 administered if needed after cycle 1 based on results bone marrow evaluation). Phase 1b consolidation: 80-120 mg, oral, daily for day 1 up to day 21 of the 28-day cycles, for a total of 12 total induction and consolidation cycles. Phase 1b induction and consolidation dose and duration may be escalated or de-escalated based on occurrence of dose-limiting toxicity. Phase 2 induction and consolidation dosage to be based on results of Phase 1b. Phase 1b and 2 maintenance: 120 mg, oral, daily for 28 days of the 28-day cycles until patient is minimal residual disease negative for FLT3 based on scheduled bone marrow biopsy, progression of disease, unacceptable toxicities, or desire to discontinue therapy.
Trial: NCT03013998
Drug: Venetoclax (BAML-16-001-S12 Arm A)
DrugBank: Venetoclax (DB11581)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 400 mg, oral, on days 1 through 28 of each 28-day cycle for up to 2 cycles or until unacceptable toxicity or death. For Cycle 1, day 1 dose is 100 mg, day 2 dose 200 mg, and day 3 onward dose is 400 mg. (Dose adjusted by anti-fungal agent use per the package insert.)