TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02481674
Drug: VX15/2503
Normalized name: VX15/2503
DrugBank: Pepinemab (DB15155)
Approvals — FDA: no, EMA: no, PMDA: no
Description: VX15/2503 (pepinemab) is a humanized IgG4 monoclonal antibody and will be administered intravenously at a dose of 20 mg/kg. The antibody is formulated at 20 mg/mL in 20 mM Sodium Acetate buffer, pH 5.4, containing 130 mM Sodium Chloride and 0.02% Polysorbate 80.
Study: NCT02000440
Drug: Losmapimod
Normalized name: Losmapimod
DrugBank: Losmapimod (DB12270)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Losmapimod (micronized GW856553X) will be supplied as a film coated white, 7 mm round, biconvex, plain faced, tablet. Oral doses of losmapimod, 7.5 mg (1 tablet) or 15 mg (2 tablets), will be taken twice daily (BID) with food and swallowed whole (not chewed or crushed)
Study: NCT01649778
Drug: Pazopanib
Normalized name: Pazopanib
DrugBank: Pazopanib (DB06589)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Prospective Observational study collecting real world data on Pazopanib in patients with advanced or metastatic Renal Cell Carcinoma. Study is considered non-interventional, no drug will be provided. No study visits or procedures are mandated per protocol.
Study: NCT01134185
Drug: prucalopride
Normalized name: PRUCALOPRIDE
DrugBank: Prucalopride (DB06480)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: single oral dose of 2 mg prucalopride
Study: NCT01134185
Drug: prucalopride
Normalized name: PRUCALOPRIDE
DrugBank: Prucalopride (DB06480)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: single dose of 2 mg prucalopride
Study: NCT03469557
Drug: Tislelizumab
Normalized name: Tislelizumab
DrugBank: Tislelizumab (DB14922)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects will be treated with BGB A317 200 mg IV on Day 1 during each 21-day cycle. BGB A317 will be administered until disease progression, intolerable toxicity, or treatment discontinuation for any other reason.
Study: NCT03469557
Drug: Cisplatin
Normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Subjects will be treated with cisplatin 80 mg/m² IV on Day 1 during each 21-day cycle. Cisplatinwill be given for up to 6 cycles.
Study: NCT03469557
Drug: 5-FU
Normalized name: 5-FU
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Subjects will be treated with 5-FU 800 mg/m²/day IV using continuous pumping system on Days 1 through 5 during each 21-day cycle. 5-FU will be given for up to 6 cycles.
Study: NCT03469557
Drug: Oxaliplatin
Normalized name: Oxaliplatin
DrugBank: Oxaliplatin (DB00526)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Subjects will be treated with oxaliplatin 130 mg/m² IV on Day 1 during each 21-day cycle. Oxaliplatin will be administered for up to 6 cycles.
Study: NCT03691376
Drug: Melphalan
Normalized name: Melphalan
DrugBank: Melphalan (DB01042)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given IV
Study: NCT04438265
Drug: levobupivacaine
Normalized name: Levobupivacaine
DrugBank: Levobupivacaine (DB01002)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: local anesthetic
Study: NCT00002715
Drug: Etoposide
Normalized name: Etoposide
DrugBank: Etoposide (DB00773)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: A component of the Stanford V regimen.
Study: NCT00002715
Drug: Mechlorethamine hydrochloride
Normalized name: Mechlorethamine hydrochloride
DrugBank: Mechlorethamine (DB00888)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: A component of the Stanford V regimen.
Study: NCT00002715
Drug: Prednisone
Normalized name: Prednisone
DrugBank: Prednisone (DB00635)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: A component of the Stanford V regimen.
Study: NCT00002715
Drug: Vinblastine
Normalized name: Vinblastine
DrugBank: Vinblastine (DB00570)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: A component of the Stanford V regimen.
Study: NCT00002715
Drug: Vincristine sulfate
Normalized name: Vincristine Sulfate
DrugBank: Vincristine (DB00541)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: A component of the Stanford V regimen.
Study: NCT03593109
Drug: Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy
Normalized name: Anti-BCMA CAR T cell
DrugBank: Idecabtagene vicleucel (DB16665)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of CAR-T cells. After a pre-treatment lymphodepletion therapy, patients will receive the Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy by intravenous injection.
Study: NCT03645824
Drug: Pacritinib
Normalized name: Pacritinib
DrugBank: Pacritinib (DB11697)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Patients receive up to 4 cycles of pacritinib before allo-SCT
Study: NCT00541658
Drug: risedronate
Normalized name: Risedronate
DrugBank: Risedronic acid (DB00884)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 5 mg Immediate-release Risedronate Administered At Least 30 Minutes Before Breakfast Daily
Study: NCT00541658
Drug: risedronate
Normalized name: Risedronate
DrugBank: Risedronic acid (DB00884)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 35 mg Delayed-release Risedronate Administered Immediately Following Breakfast Weekly
Study: NCT00541658
Drug: risedronate
Normalized name: Risedronate
DrugBank: Risedronic acid (DB00884)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 35 mg Delayed-release Risedronate Administered At Least 30 Minutes Before Breakfast Weekly
Study: NCT04638543
Drug: ABP-671
Normalized name: ABPC
DrugBank: Ampicillin (DB00415)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: ABP-671 Tablet
Study: NCT04176172
Drug: Varenicline
Normalized name: Varenicline
DrugBank: Varenicline (DB01273)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Participants will receive open-label varenicline for 12 weeks.
Study: NCT04176172
Drug: Nicotine patch
Normalized name: Nicotine Patch
DrugBank: Nicotine (DB00184)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Participants will receive open-label nicotine patch for 12 weeks. (Participants in the NMR-tailored treatment arms will receive either varenicline OR patch; they will not receive both)
Study: NCT00569400
Drug: human insulin
Normalized name: Human insulin
DrugBank: Insulin human (DB00030)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00614302
Drug: TPV
Normalized name: Tipranavir
DrugBank: Tipranavir (DB00932)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT03061916
Drug: Chlorhexidine Gluconate
Normalized name: Chlorhexidine Gluconate
DrugBank: Chlorhexidine (DB00878)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Chlorhexidine Gluconate will be given to participants after baseline collection of saliva
Study: NCT00399542
Drug: Lubiprostone
Normalized name: Lubiprostone
DrugBank: Lubiprostone (DB01046)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00174187
Drug: Somatropin
Normalized name: Somatropin
DrugBank: Somatotropin (DB00052)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: liquid, daily, until final height Dosage: 0,46 mg/kg/week . The maximum dose should not exceed 50 µg/Kg/day
Study: NCT02000206
Drug: Propofol
Normalized name: Propofol
DrugBank: Propofol (DB00818)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT02000206
Drug: Ketamine
Normalized name: Ketamine
DrugBank: Ketamine (DB01221)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00635193
Drug: M200 (Volociximab)
Normalized name: Volociximab
DrugBank: Volociximab (DB06647)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 7.5 mg/kg, IV infusion every week until disease progression
Study: NCT00635193
Drug: M200 (Volociximab)
Normalized name: Volociximab
DrugBank: Volociximab (DB06647)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 15 mg/kg, IV infusions every week until disease progression
Study: NCT02000206
Drug: Alfentanil
Normalized name: Alfentanil
DrugBank: Alfentanil (DB00802)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT02211846
Drug: Mirabegron
Normalized name: Mirabegron
DrugBank: Mirabegron (DB08893)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: oral
Study: NCT00635193
Drug: M200 (Volociximab)
Normalized name: Volociximab
DrugBank: Volociximab (DB06647)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 15 mg/kg, IV infustions every other week until disease progression
Study: NCT02764229
Drug: LYC-30937-EC
Normalized name: EC-0652
DrugBank: EC-0652 (DB15340)
Approvals — FDA: no, EMA: no, PMDA: no
Description: LYC-30937-EC 25 mg by mouth once daily
Study: NCT04035707
Drug: Rocuronium
Normalized name: Rocuronium
DrugBank: Rocuronium (DB00728)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: using rocuronium as a relaxants during general anaesthesia
Study: NCT04035707
Drug: general volatile anaesthesia
Normalized name: coal tar pitch volatiles
DrugBank: Coal tar (DB11082)
Approvals — FDA: no, EMA: no, PMDA: no
Description: method of anaesthesia
Study: NCT02225626
Drug: BI 1060469
Normalized name: BI 2536
DrugBank: BI 2536 (DB16107)
Approvals — FDA: no, EMA: no, PMDA: no
Description: tablet, oral administration with 240 mL of water after an overnight fast of at least 10 h
Study: NCT02225626
Drug: BI 1060469
Normalized name: BI 2536
DrugBank: BI 2536 (DB16107)
Approvals — FDA: no, EMA: no, PMDA: no
Description: tablet, oral administration with 240 mL water 30 minutes after subject is served a standardised high-caloric high-fat administration
Study: NCT02276274
Drug: SYR-322-MET
Normalized name: Met
DrugBank: Methionine (DB00134)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Oral administration of SYR-322-MET
Study: NCT00126321
Drug: cladribine
Normalized name: Cladribine
DrugBank: Cladribine (DB00242)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 2-chlorodeoxyadenosine, 2-CdA
Study: NCT00015912
Drug: thalidomide
Normalized name: Thalidomide
DrugBank: Thalidomide (DB01041)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given orally
Study: NCT01326312
Drug: GTx-758 1000mg
Normalized name: toremifene
DrugBank: GTX-758 (DB14969)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
Study: NCT01326312
Drug: Lupron Depot
Normalized name: Lupron Depot
DrugBank: Leuprolide (DB00007)
Approvals — FDA: no, EMA: no, PMDA: no
Description: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
Study: NCT01326312
Drug: GTx-758 2000mg
Normalized name: toremifene
DrugBank: GTX-758 (DB14969)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
Study: NCT00672490
Drug: Quetiapine Fumarate
Normalized name: Quetiapine Fumarate
DrugBank: Quetiapine (DB01224)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Oral treatment, twice daily. 100 mg/day at Day 1, 200 mg/day at Day 2, 300 mg/day at Day 3, 400 mg/day at Day 4, from 400 mg/day to 600 mg/day before Day 8, from 600 mg/day to 800 thereafter, judged by the investigator.~Tablets
Study: NCT00672490
Drug: Lithium
Normalized name: Lithium
DrugBank: Lithium citrate (DB14507)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Oral treatment, twice daily. 250 mg/day to 2000mg/day from Day1 to Day 7, 500mg/day to 2000mg/day thereafter, judged by the investigator.
Study: NCT02688881
Drug: sirolimus
Normalized name: Sirolimus
DrugBank: Sirolimus (DB00877)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Rapamune
Study: NCT03736863
Drug: Apatinib+ SHR-1210（Camrelizumab）
DrugBank: Camrelizumab (DB14776)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Apatinib 250mg, q.d.po+SHR-1210（Camrelizumab）200 mg，Intravenous injection，q2W
Study: NCT03736863
Drug: Apatinib+ SHR-1316（Adebrelimab）
DrugBank: Adebrelimab (DB16412)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Apatinib 250mg, q.d.po+SHR-1316（Adebrelimab） 1200 mg，Intravenous injection，q2W
Study: NCT03736863
Drug: SHR-1316（Adebrelimab）+SHR-A2009
DrugBank: Adebrelimab (DB16412)
Approvals — FDA: no, EMA: no, PMDA: no
Description: SHR-1316 was administered intravenously, 1200mg, Q3W; SHR-A2009 8mg/kg, iv, Q3W,
Study: NCT02223520
Drug: Mupirocin and Chlorhexidine
Normalized name: Mupirocin
DrugBank: Mupirocin (DB00410)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT04080505
Drug: SSKI- Potassium Iodide
Normalized name: SSKI brand of Potassium Iodide
DrugBank: Potassium Iodide (DB06715)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 1g/mL, 2 drops orally 3 times a day for 7 days before surgery
Study: NCT04235608
Drug: Inhaled sedation with sevoflurane
Normalized name: sevoflurane Inhalation Solution
DrugBank: Sevoflurane (DB01236)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Inhaled sedation with sevoflurane using the Anesthesia Conserving Device (AnaConDa-S, Sedana Medical, Danderyd, Sweden).
Study: NCT04235608
Drug: intravenous sedation with propofol
Normalized name: Propofol
DrugBank: Propofol (DB00818)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: intravenous sedation with propofol, as already routinely used in participating ICUs.
Study: NCT03667820
Drug: Osimertinib
Normalized name: Osimertinib
DrugBank: Osimertinib (DB09330)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Osimertinib 80mg tablet to be taken once daily.
Study: NCT04184921
Drug: Aspirin 100mg
Normalized name: Aspirin
DrugBank: Acetylsalicylic acid (DB00945)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Aspirin, also known as acetylsalicylic acid (ASA), is a very safe medication used to treat pain, fever, or inflammation.
Study: NCT04322890
Drug: Osimertinib
Normalized name: Osimertinib
DrugBank: Osimertinib (DB09330)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Osimertinib 80mg, po, qd;
Study: NCT04322890
Drug: Alectinib 150 MG
Normalized name: alectinib 150 MG
DrugBank: Alectinib (DB11363)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Alectinib 600mg, po, qd; Lorlatinib, 100mg, po, qd;
Study: NCT04322890
Drug: Crizotinib 250 MG
Normalized name: crizotinib 250 MG
DrugBank: Crizotinib (DB08865)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Crizotinib 250 MG po bid.
Study: NCT04322890
Drug: Savolitinib, Crizotinib.
DrugBank: Crizotinib (DB08865)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Savolitinib, 300mg po qd.
Study: NCT02283853
Drug: dimethyl fumarate
Normalized name: Dimethyl Fumarate
DrugBank: Dimethyl fumarate (DB08908)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: administered orally
Study: NCT02283853
Drug: Interferon β-1a
Normalized name: Interferon beta 1a
DrugBank: Interferon beta-1a (DB00060)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: administered by intramuscular injection
Study: NCT00723736
Drug: Desloratadine
Normalized name: Desloratadine
DrugBank: Desloratadine (DB00967)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 2.5 ml (1.25 mg) once daily
Study: NCT00938704
Drug: carboxymethylcellulose 0.5% +glycerin 0.9%
DrugBank: Glycerin (DB09462)
Approvals — FDA: no, EMA: no, PMDA: no
Description: To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container.
Study: NCT00938704
Drug: sodium hyaluronate 0.18%
DrugBank: Sodium citrate (DB09154)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container.
Study: NCT05063058
Drug: Molecular guided therapy
Normalized name: Molecular AF
DrugBank: Tolnaftate (DB00525)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Biomarker-driven therapy according to recommandations of the precision oncology tumor board including MEK Inhibitors (Trametinib 2 mg/d, Selumetinib 75 mg 2/d), MET Inhibitors (Crizotinib 250 mg 2/d, or Cabozantinib 60mg/d), RAS Inhibitor (Sorafenib 400 mg 2/d), Cell cycle Inhibitor (Palbociclib 125 mg/d) and Checkpoint Inhibitor (Nivolumab 240 mg every 2 weeks).
Study: NCT02142699
Drug: Heme arginate
Normalized name: Heme arginate
DrugBank: Heme arginate (DB17310)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02582775
Drug: Thymoglobulin
Normalized name: Thymoglobulin
DrugBank: Antithymocyte immunoglobulin (rabbit) (DB00098)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 0.5 mg/kg IV over 6 hours on day -9 and 2 mg/kg IV over 4 hours on day -8 and day -7 with premeds and solumedrol through day -2
Study: NCT02582775
Drug: Fludarabine
Normalized name: Fludarabine
DrugBank: Fludarabine (DB01073)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 30 mg/m2 IV over 60 minutes days -6 through day -2
Study: NCT02582775
Drug: Tacrolimus
Normalized name: Tacrolimus
DrugBank: Tacrolimus (DB00864)
Approvals — FDA: yes, EMA: no, PMDA: 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.
Study: NCT02582775
Drug: Mycophenolate Mofetil
Normalized name: Mycophenolate Mofetil
DrugBank: Mycophenolate mofetil (DB00688)
Approvals — FDA: yes, EMA: no, PMDA: 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
Study: NCT00394498
Drug: Granulocyte Colony Stimulating Factor
Normalized name: Granulocyte colony stimulating factor
DrugBank: Filgrastim (DB00099)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Study: NCT02582775
Drug: Busulfan
Normalized name: Busulfan
DrugBank: Busulfan (DB01008)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: busulfan IV over 3 hours on days -3 and -2 for HLA-mismatched BM recipients only (Arms F and G)
Study: NCT02352896
Drug: EPI-743
Normalized name: 8-epi-cyanocobalamin
DrugBank: 8-epi-Cyanocobalamin (DB14092)
Approvals — FDA: no, EMA: no, PMDA: no
Description: EPI-743 100 milligrams/milliliter (mg/mL) oral solution will be administered per dose and schedule specified in the arm.
Study: NCT03969004
Drug: Cemiplimab
Normalized name: CEMIPLIMAB
DrugBank: Cemiplimab (DB14707)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Intravenous (IV) infusion over 30 minutes
Study: NCT03008278
Drug: Olaparib
Normalized name: Olaparib
DrugBank: Olaparib (DB09074)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Give PO
Study: NCT02023463
Drug: Enzalutamide
Normalized name: Enzalutamide
DrugBank: Enzalutamide (DB08899)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given PO
Study: NCT02023463
Drug: Goserelin acetate
Normalized name: Goserelin Acetate
DrugBank: Goserelin (DB00014)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given SC
Study: NCT02023463
Drug: Leuprolide acetate
Normalized name: Leuprolide Acetate
DrugBank: Leuprolide (DB00007)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Given IM or SC
Study: NCT03013998
Drug: Daunorubicin (BAML-16-001-S1)
Normalized name: daunorubicin
DrugBank: Daunorubicin (DB00694)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 60 mg/m2, IV, on days 4, 5, and 6 of the induction cycle
Study: NCT03013998
Drug: Cytarabine (BAML-16-001-S1)
Normalized name: Cytarabine
DrugBank: Cytarabine (DB00987)
Approvals — FDA: yes, EMA: no, PMDA: 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
Study: NCT03013998
Drug: Azacitidine (BAML-16-001-S2)
Normalized name: Azacitidine
DrugBank: Azacitidine (DB00928)
Approvals — FDA: yes, EMA: yes, PMDA: 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
Study: NCT03013998
Drug: AG-221 (BAML-16-001-S3)
Normalized name: Bamlanivimab
DrugBank: Bamlanivimab (DB15718)
Approvals — FDA: yes, EMA: no, PMDA: 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.
Study: NCT03013998
Drug: Azacitidine (BAML-16-001-S3)
Normalized name: Azacitidine
DrugBank: Azacitidine (DB00928)
Approvals — FDA: yes, EMA: yes, PMDA: 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
Study: NCT03013998
Drug: Entospletinib (BAML-16-001-S4)
Normalized name: Bamlanivimab
DrugBank: Entospletinib (DB12121)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 200 mg, oral, twice daily for 5 years until time of intolerance or disease progression. Dose may be escalated to 400 mg.
Study: NCT03013998
Drug: Azacitidine (BAML-16-001-S4)
Normalized name: Azacitidine
DrugBank: Azacitidine (DB00928)
Approvals — FDA: yes, EMA: yes, PMDA: 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.
Study: NCT03013998
Drug: Entospletinib (BAML-16-001-S5)
Normalized name: Bamlanivimab
DrugBank: Entospletinib (DB12121)
Approvals — FDA: yes, EMA: no, PMDA: 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.
Study: NCT03013998
Drug: Decitabine (BAML-16-001-S5)
Normalized name: Decitabine
DrugBank: Decitabine (DB01262)
Approvals — FDA: yes, EMA: no, PMDA: 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.
Study: NCT00914940
Drug: Fludarabine Phosphate
Normalized name: Fludarabine Phosphate
DrugBank: Fludarabine (DB01073)
Approvals — FDA: yes, EMA: no, PMDA: 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.
Study: NCT00914940
Drug: Tacrolimus
Normalized name: Tacrolimus
DrugBank: Tacrolimus (DB00864)
Approvals — FDA: yes, EMA: no, PMDA: 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.
Study: NCT03013998
Drug: Entospletinib (BAML-16-001-S6)
Normalized name: Bamlanivimab
DrugBank: Entospletinib (DB12121)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 400 mg, oral, twice daily for 2 years until time of intolerance or disease progression.
Study: NCT03013998
Drug: Daunorubicin (BAML-16-001-S6)
Normalized name: daunorubicin
DrugBank: Daunorubicin (DB00694)
Approvals — FDA: yes, EMA: no, PMDA: 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