TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02485834
Drug: Irinotecan
Normalized name: Irinotecan
DrugBank: Irinotecan (DB00762)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 50 mg/m\^2 IV
Study: NCT03697564
Drug: Gemcitabine
Normalized name: Gemcitabine
DrugBank: Gemcitabine (DB00441)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 1000 mg/m2 IV on days 1, 8, and 15 Q4W
Study: NCT03697564
Drug: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]
DrugBank: Nivolumab (DB09035)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: 480mg IV on Day 1 Q4W
Study: NCT03697564
Drug: Cabiralizumab
Normalized name: Cabiralizumab
DrugBank: Cabiralizumab (DB15082)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 4mg/kg IV on day 1 and 15 Q4W
Study: NCT03969446
Drug: Decitabine
Normalized name: Decitabine
DrugBank: Decitabine (DB01262)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given IV
Study: NCT03969446
Drug: Venetoclax
Normalized name: Venetoclax
DrugBank: Venetoclax (DB11581)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Given PO
Study: NCT00742612
Drug: Placebo (normal saline)
Normalized name: NS-2359
DrugBank: NS-2359 (DB05805)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Study drug treatment will be initiated 1 hour prior to the induction of anesthesia with a loading dose given over 1 hour in 3 successively increasing, 20-minute step infusions. The placebo group will be dosed to a steady-state plasma concentration using a loading dose infusion sequence of 0.0015 mg/kg/min for 20 minutes, 0.003 mg/kg/min for the next 20 minutes, and then 0.006 mg/kg/min for the final 20 minutes; thereafter, their maintenance infusion rate is to be 0.0006 mg/kg/min.
Study: NCT00006394
Drug: growth hormone
Normalized name: Growth hormone
DrugBank: Somatotropin (DB00052)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01668784
Drug: Everolimus
Normalized name: Everolimus
DrugBank: Everolimus (DB01590)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Study: NCT03745326
Drug: Fludarabine
Normalized name: Fludarabine
DrugBank: Fludarabine (DB01073)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Days -7 to -3: Fludarabine 25 mg/m\^2/day IVPB daily over 30 minutes for 5 days.
Study: NCT03745326
Drug: Aldesleukin
Normalized name: Aldesleukin
DrugBank: Aldesleukin (DB00041)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 3 days (maximum 9 doses).
Study: NCT03139305
Drug: Glucagon
Normalized name: Glucagon
DrugBank: Glucagon (DB00040)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Low dose intravenous infusion for 72 hours at 12.5 ng/kg/min
Study: NCT03139305
Drug: Glucagon
Normalized name: Glucagon
DrugBank: Glucagon (DB00040)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: High dose intravenous infusion for 72 hours at 25 ng/kg/min
Study: NCT03533283
Drug: Glofitamab
Normalized name: Glofitamab
DrugBank: Glofitamab (DB16371)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Glofitamab will be administered through IV infusion every 3 weeks (Q3W) beginning Cycle 1, Day 1, for up to 17 cycles (Cycle = 21 days). Step-up dosing, in which an initial lower dose will be followed by a higher dose 1 week later, will be considered for the initial treatment phase and for Cycle 9 of the re-treatment phase.
Study: NCT03533283
Drug: Atezolizumab
Normalized name: Atezolizumab
DrugBank: Atezolizumab (DB11595)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Atezolizumab will be administered in combination with Glofitamab through IV infusion Q3W from Cycle 2, Day 1, for up to 16 cycles (Cycle = 21 days).
Study: NCT03533283
Drug: Obinutuzumab
Normalized name: Obinutuzumab
DrugBank: Obinutuzumab (DB08935)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Obinutuzumab will be administered once, through IV infusion, at a fixed dose 7 days before the first dose of Glofitamab.
Study: NCT03533283
Drug: Tocilizumab
Normalized name: Tocilizumab
DrugBank: Tocilizumab (DB06273)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Tocilizumab will be administered as necessary to treat cytokine release syndrome (CRS).
Study: NCT03533283
Drug: Polatuzumab Vedotin
Normalized name: polatuzumab vedotin
DrugBank: Polatuzumab vedotin (DB12240)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Polatuzumab vedotin will be administered in combination with Glofitamab (on different days) Q3W from Cycle 1, Day 2, for up to 12 cycles (Cycle = 21 days).
Study: NCT03533283
Drug: 89Zr-Df-IAB22M2C
Normalized name: Zirconium zr 89-df-iab22m2c
DrugBank: Zirconium (89Zr) crefmirlimab berdoxam (DB19157)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive 89Zr-Df-IAB22M2C (Cycle 1 only) prior to obinutuzumab pre-treatment and again on Day 10 after dosing with glofitamab, followed by PET/CT.
Study: NCT04046445
Drug: BI 754091
Normalized name: Anti-pd-1 monoclonal antibody bi 754091
DrugBank: Ezabenlimab (DB17483)
Approvals — FDA: no, EMA: no, PMDA: no
Description: ≥ 7 IV infusions
Study: NCT04046445
Drug: VSV-GP128
Normalized name: Recombinant Vesicular Stomatitis Virus (rVSV) strain Indiana with a deletion of the VSV envelope glycoprotein (G) replaced with the Zaire Ebola Virus (ZEBOV) Kikwit 1995 strain surface glycoprotein (GP)
DrugBank: Ebola Zaire vaccine (live, attenuated) (DB15595)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 single IV injection
Study: NCT03263026
Drug: Enzastaurin Hydrochloride
Normalized name: Chlorpromazine Hydrochloride
DrugBank: Enzastaurin (DB06486)
Approvals — FDA: no, EMA: no, PMDA: no
Description: R-CHOP + Enzastaurin (Kinenza®) 125 mg
Study: NCT00448240
Drug: Erlotinib
Normalized name: Erlotinib
DrugBank: Erlotinib (DB00530)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: loading dose of 300 mg on Day 2 followed by 150 mg daily Days 3 - 17 of each cycle of paclitaxel and cisplatin/carboplatin
Study: NCT03522246
Drug: Rucaparib
Normalized name: Rucaparib
DrugBank: Rucaparib (DB12332)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Oral rucaparib will be administered twice daily
Study: NCT03522246
Drug: Nivolumab
Normalized name: Nivolumab
DrugBank: Nivolumab (DB09035)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: IV nivolumab will be administered once every 4 weeks
Study: NCT04032964
Drug: L19TNF
Normalized name: Daromun component l19tnf
DrugBank: Onfekafusp alfa (DB16269)
Approvals — FDA: no, EMA: no, PMDA: no
Description: L19TNF 13 µg/kg i.v. will be administered on day 1, 3 and 5 of each 21-day cycle
Study: NCT01391962
Drug: Cediranib
Normalized name: cediranib
DrugBank: Cediranib (DB04849)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Cediranib, a small molecule inhibitor of vascular endothelial growth factor (VEGF) receptor tyrosine kinases, is showing preliminary evidence of activity in patients with alveolar soft part sarcoma (ASPS).
Study: NCT01391962
Drug: Sunitinib
Normalized name: Sunitinib
DrugBank: Sunitinib (DB01268)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Sunitinib, a small molecule inhibitor of vascular endothelial growth factor (VEGF) receptor tyrosine kinases, is showing preliminary evidence of activity in patients with alveolar soft part sarcoma (ASPS).
Study: NCT01391962
Drug: Warfarin
Normalized name: Warfarin
DrugBank: Warfarin (DB00682)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 2mg daily for prophylaxis of thrombosis.
Study: NCT03879512
Drug: depletion of regulatory T cells
Normalized name: Autologous CD4+CD25hiFoxP3+regulatory T cells
DrugBank: Autologous CD4+CD25hiFoxP3+regulatory T cells (DB18655)
Approvals — FDA: no, EMA: no, PMDA: no
Description: oral metronomic cyclophosphamide
Study: NCT00392327
Drug: Carboplatin
Normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT00392327
Drug: Cisplatin
Normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given IV
Study: NCT00392327
Drug: Isotretinoin
Normalized name: Isotretinoin
DrugBank: Isotretinoin (DB00982)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given PO
Study: NCT00392327
Drug: Vincristine Sulfate
Normalized name: Vincristine Sulfate
DrugBank: Vincristine (DB00541)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given IV
Study: NCT01404819
Drug: Anesthesia with Xenon
Normalized name: xenon
DrugBank: Xenon (DB13453)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients undergo anesthesia with xenon (remifentanil with xenon).
Study: NCT04500587
Drug: ZN-d5
Normalized name: VITAMIN D5
DrugBank: 1alpha-Hydroxyvitamin D5 (DB13097)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral agent; 25 mg or 100 mg formulation
Study: NCT03571438
Drug: Sunitinib
Normalized name: Sunitinib
DrugBank: Sunitinib (DB01268)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Treatment of cell culture with Sunitinib
Study: NCT03571438
Drug: Pazopanib
Normalized name: Pazopanib
DrugBank: Pazopanib (DB06589)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Treatment of cell culture with Pazopanib
Study: NCT03571438
Drug: Temsirolimus
Normalized name: Temsirolimus
DrugBank: Temsirolimus (DB06287)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Treatment of cell culture with Temsirolimus
Study: NCT02338674
Drug: Tenofovir and telbivudine
DrugBank: Telbivudine (DB01265)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: tenofovir and telbivudine administered at least 48 weeks
Study: NCT02338674
Drug: Tenofovir
Normalized name: Tenofovir
DrugBank: Tenofovir (DB14126)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: tenofovir administered at least 48 weeks
Study: NCT02525757
Drug: Carboplatin
Normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: AUC 2 by vein once a week on Day 1 during radiation therapy. During consolidation chemotherapy, Carboplatin given at AUC 6 by vein on Days 1 and 22 for 2 cycles.
Study: NCT02525757
Drug: Paclitaxel
Normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: 50 mg/m2 by vein once a week on Day 1 during radiation therapy. During consolidation chemotherapy, Paclitaxel given at 200 mg/m2 on Days 1 and 22 for 2 cycles.
Study: NCT02546986
Drug: CC-486
Normalized name: CC
DrugBank: Cholecalciferol (DB00169)
Approvals — FDA: no, EMA: no, PMDA: no
Description: CC-486 will be administered orally at a dose of 300 mg daily on days 1-14 of each 21-day cycle.
Study: NCT02546986
Drug: Pembrolizumab
Normalized name: Pembrolizumab
DrugBank: Pembrolizumab (DB09037)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Pembrolizumab will be administered as a 30-minute IV infusion on day 1 of each 21-day cycle.
Study: NCT03944434
Drug: Ribociclib
Normalized name: Ribociclib
DrugBank: Ribociclib (DB11730)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: ribociclib 600 mg/day orally
Study: NCT03775109
Drug: Canakinumab 150mg/ml solution for injection
DrugBank: Canakinumab (DB06168)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Canakinumab 150mg/ml solution for injection
Study: NCT00474812
Drug: dasatinib
Normalized name: Dasatinib
DrugBank: Dasatinib (DB01254)
Approvals — FDA: yes, EMA: yes, PMDA: no
Study: NCT01506596
Drug: pazopanib
Normalized name: Pazopanib
DrugBank: Pazopanib (DB06589)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.
Study: NCT03816696
Drug: DTG
Normalized name: Dolutegravir
DrugBank: Dolutegravir (DB08930)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: DTG will be available as 50 mg tablets. Subjects will be administered DTG 50 mg QD via the oral route.
Study: NCT04030169
Drug: Midomafetamine HCl
Normalized name: Chlorpromazine Hydrochloride
DrugBank: Midomafetamine (DB01454)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Non-directive psychotherapy conducted during MDMA-assisted psychotherapy session
Study: NCT02661893
Drug: JNJ-42847922
Normalized name: JNJ-42847922
DrugBank: Seltorexant (DB14961)
Approvals — FDA: no, EMA: no, PMDA: no
Description: A single oral dose of 40 milligram (mg) (=2\*20 mg) dose of JNJ42847922 on Day 1, Day 5 and Day 12.
Study: NCT02661893
Drug: Rifampin
Normalized name: Rifampin
DrugBank: Rifampin (DB01045)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral dose of rifampin 600 mg (2\*300 mg) on Day 5 and once daily dosing of rifampin with an oral dose of rifampin 600 mg (2\*300 mg) on Days 5 to 12.
Study: NCT03743636
Drug: Nicotinamide riboside
Normalized name: Nicotinamide riboside
DrugBank: Nicotinamide riboside (DB14933)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants randomized to the NR + resveratrol arm or the NR + placebo arm of the study will receive 1,000 mg of NR daily for six months.
Study: NCT03743636
Drug: Resveratrol
Normalized name: Resveratrol
DrugBank: Resveratrol (DB02709)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants randomized to the NR + resveratrol arm of the study will receive 125 mg of resveratrol daily for six months.
Study: NCT04249947
Drug: Rimiducid
Normalized name: Rimiducid
DrugBank: Rimiducid (DB04974)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Rimiducid (safety switch activator) may be administered as indicated
Study: NCT03300557
Drug: Exemestane
Normalized name: Exemestane
DrugBank: Exemestane (DB00990)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given PO
Study: NCT02720445
Drug: Nicotine Transdermal Patch
Normalized name: MENTHOL 0.3 g in 100 TOPICAL PATCH [Aroamas Cot Nicotine Transdermal Patches]
DrugBank: Nicotine (DB00184)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 21mg Nicotine transdermal patches worn during waking hours. Active dose will titrate up from 3.5mg to 21mg in the first 6 weeks of treatment, remain at 21mg for 22.5 months, and then taper down in the final month of treatment.
Study: NCT02183220
Drug: Metamizol
Normalized name: Metamizol
DrugBank: Metamizole (DB04817)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04052516
Drug: Icosabutate
Normalized name: Icosabutate
DrugBank: Icosabutate (DB12990)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Icosabutate oral capsule once daily
Study: NCT03542812
Drug: L-Citrulline
Normalized name: L-citrulline
DrugBank: Citrulline (DB00155)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: The L-citrulline will be procured in powder form and will be solubilized in sterile water to achieve a concentration of 50 mg/ml. Therefore, 3 ml/kg of the solubilized L-citrulline (50 mg/ml) will be administered per dose for the single-dose groups and the dose administered to the steady-state group will be determined from results from the single-dose studies.
Study: NCT01196065
Drug: memantine
Normalized name: Memantine
DrugBank: Memantine (DB01043)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: multiple doses to steady state
Study: NCT04521413
Drug: Pembrolizumab
Normalized name: Pembrolizumab
DrugBank: Pembrolizumab (DB09037)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Pembrolizumab will be given at its labeled dose and schedule, 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks.
Study: NCT00693524
Drug: tacrolimus
Normalized name: Tacrolimus
DrugBank: Tacrolimus (DB00864)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: oral
Study: NCT00693524
Drug: Anti-IL2R AB
Normalized name: AB-8939
DrugBank: AB-8939 (DB17115)
Approvals — FDA: no, EMA: no, PMDA: no
Description: i.v.
Study: NCT00693524
Drug: Mycophenolate mofetil
Normalized name: Mycophenolate Mofetil
DrugBank: Mycophenolate mofetil (DB00688)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: oral
Study: NCT00693524
Drug: prednisone
Normalized name: Prednisone
DrugBank: Prednisone (DB00635)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: oral
Study: NCT03625323
Drug: eftilagimod alpha
Normalized name: alpha tocopherol
DrugBank: Eftilagimod alfa (DB16150)
Approvals — FDA: no, EMA: no, PMDA: no
Description: APC activator, MHC II agonist, LAG-3 fusion protein
Study: NCT03625323
Drug: pembrolizumab (KEYTRUDA®)
Normalized name: pembrolizumab Injection [Keytruda]
DrugBank: Pembrolizumab (DB09037)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: anti-PD-1 antibody
Study: NCT04205812
Drug: Retifanlimab
Normalized name: Retifanlimab
DrugBank: Retifanlimab (DB15766)
Approvals — FDA: no, EMA: no, PMDA: no
Description: INCMGA00012 administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.
Study: NCT04205812
Drug: Pemetrexed
Normalized name: Pemetrexed
DrugBank: Pemetrexed (DB00642)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Pemetrexed administered intravenously every 3 weeks on Day 1 of each cycle.
Study: NCT04205812
Drug: Cisplatin
Normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Cisplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.
Study: NCT04205812
Drug: Carboplatin
Normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Carboplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.
Study: NCT04205812
Drug: Paclitaxel
Normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Paclitaxel administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.
Study: NCT04205812
Drug: nab-Paclitaxel
Normalized name: NAB-PACLITAXEL COMPONENT PACLITAXEL
DrugBank: Paclitaxel (DB01229)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: nab-Paclitaxel administered intravenously every 3 weeks on Days 1, 8, and 15 of each cycle for 4 cycles.
Study: NCT01745965
Drug: T-DM1
Normalized name: T-DM1
DrugBank: Trastuzumab emtansine (DB05773)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Study: NCT01745965
Drug: Trastuzumab
Normalized name: trastuzumab
DrugBank: Trastuzumab (DB00072)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Study: NCT05066516
Drug: FCDP, dapagliflozin 10mg/linagliptin 5 mg or co-administration of a single dose of dapagliflozin and linagliptin
DrugBank: Dapagliflozin (DB06292)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: FCDP, dapagliflozin 10mg/linagliptin 5 mg or ICs, co-administration of a single dose of dapagliflozin and linagliptin
Study: NCT04242446
Drug: Bimekizumab
Normalized name: bimekizumab
DrugBank: Bimekizumab (DB12917)
Approvals — FDA: no, EMA: yes, PMDA: yes
Description: Subjects will receive bimekizumab at pre-specified time-points.
Study: NCT00082186
Drug: bosentan
Normalized name: Bosentan
DrugBank: Bosentan (DB00559)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Oral bosentan tablets 62.5 mg twice daly for 4 weeks, then 125 mg twice daily for 20 weeks.
Study: NCT04082429
Drug: Concizumab
Normalized name: concizumab
DrugBank: Concizumab (DB12820)
Approvals — FDA: no, EMA: no, PMDA: no
Description: When patients are randomised/allocated to concizumab prophylaxis, they will receive a loading dose of 1.0 mg/kg concizumab at visit 2a (week (Wk) 0) (arm 2, 3 and 4) or visit 9a (Wk 24) (arm 1) followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week dose adjustment period on 0.20 mg/kg concizumab, the patients can be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab. A potential dose adjustment will take place at visit 4a.1 (Wk 6) or 9a.3 (Wk 30) and will be based on the concizumab exposure level measured at the previous visit 4a (Wk 6) or 9a.2 (Wk 28). Patients who have concizumab exposure levels of 200-4000 ng/mL will stay at 0.20 mg/kg concizumab. Patients in arm 1 will continue on-demand treatment with their usual replacement therapy until visit 9a (week 24; end of main part). In the extension part, patients in arm 1 will receive daily concizumab subcutaneous injections.
Study: NCT03264131
Drug: Brentuximab Vedotin
Normalized name: Brentuximab Vedotin
DrugBank: Brentuximab vedotin (DB08870)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Brentuximab Vedotin will be given at 1.8 mg/kg IV over approximately 30 minutes on D1 every 21 days for 2-6 cycles. Responders (CR, PR or SD) who are not eligible for bone marrow transplant (BMT) and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV for approximately 30 minutes, every 21 days).
Study: NCT01373021
Drug: Dexmedetomidine
Normalized name: Dexmedetomidine
DrugBank: Dexmedetomidine (DB00633)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Fentanyl 2500mcg+Dexmedetomidine 500mcg + NS 45ml
Study: NCT02458313
Drug: DMXB-A
Normalized name: DMXB-A
DrugBank: GTS-21 (DB05708)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks.
Study: NCT00460876
Drug: Topotecan
Normalized name: Topotecan
DrugBank: Topotecan (DB01030)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00396864
Drug: NPI-0052
Normalized name: NPI 32101
DrugBank: NPI 32101 (DB05264)
Approvals — FDA: no, EMA: no, PMDA: no
Description: NPI-0052 IV injection at doses ranging from 0.0125 to 0.8 mg/m2 over 1 to 10 minutes on Day 1, Day 8, Day 15 of each 28-day Cycle; 11 dose cohorts during dose-escalation
Study: NCT03710772
Drug: Cytarabine
Normalized name: Cytarabine
DrugBank: Cytarabine (DB00987)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT03710772
Drug: Dexamethasone
Normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given PO or IV
Study: NCT03710772
Drug: Ibrutinib
Normalized name: Ibrutinib
DrugBank: Ibrutinib (DB09053)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Given PO
Study: NCT03710772
Drug: Venetoclax
Normalized name: Venetoclax
DrugBank: Venetoclax (DB11581)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Given PO
Study: NCT03710772
Drug: Vincristine Sulfate
Normalized name: Vincristine Sulfate
DrugBank: Vincristine (DB00541)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given IV
Study: NCT03747484
Drug: Avelumab
Normalized name: Avelumab
DrugBank: Avelumab (DB11945)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Given IV
Study: NCT05950165
Drug: CHO-H01
Normalized name: G-CSF (CHO cell derived)
DrugBank: Filgrastim (DB00099)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Phase 1:~Subjects will be administered intravenous (IV) infusion of assigned dose level of CHO-H01, once a week for 4 weeks (Cycle 1-28-Day cycle).~From Cycle 2 onwards, on Day 1 of each subsequent 21-day cycle until disease progression (or a total of 6 cycles \[19 weeks\] of study).
Study: NCT05950165
Drug: CHO-H01 at RP2D
Normalized name: AT-III
DrugBank: Antithrombin III human (DB11598)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects will be administered intravenous (IV) infusion of RP2D level of CHO-H01, once a week for 4 weeks (Cycle 1-28-Day cycle).~From Cycle 2 onwards, on Day 1 of each subsequent 28-day cycle until disease progression (or a total of 6 cycles \[19 weeks\] of study).
Study: NCT05950165
Drug: Lenalidomide
Normalized name: Lenalidomide
DrugBank: Lenalidomide (DB00480)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Subjects will receive oral lenalidomide 20 mg once daily from Day 1 to Day 21 per 28-day cycle.
Study: NCT03074136
Drug: 0.5% Sodium hypochlorite
DrugBank: Sodium citrate (DB09154)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Chemomechanical preparation will be completed by hand instruments, with minimal instrumentation, and usage of sodium hypochlorite with minimal bactericidal concentration (0.5%, pH 12), on room temperature (21 degrees Celsius).
Study: NCT00603408
Drug: Cisplatin
Normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
Approvals — FDA: yes, EMA: no, PMDA: no