AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT06454955
Drug: [68Ga] B7H3 Affibody-BCH
FDA approved: no
EMA approved: no
PMDA approved: no
Description: An affibody structure specifically targeting B7H3 was developed based on the B7H3 binding domain, and it was structurally optimized to yield a small molecular agent, B7H3 Affibody-BCH, suitable for nuclear medical diagnostic and therapeutic uses targeting B7H3. By labeling with the radioactive isotope \^68Ga, this agent can be used for PET/CT diagnosis of solid tumors.
Trial: NCT05629741
Drug: CMTX-101
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered as specified in the treatment arm
Trial: NCT05629741
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered as specified in the treatment arm
Trial: NCT05909059
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Received IV on Days -5 to -3 before CAR T cell therapy
Trial: NCT05221957
Drug: Iron(III)isomaltoside
RxNorm normalized name: Iron isomaltoside 1000
DrugBank: Iron isomaltoside 1000 (DB12208)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Individual weight and hemoglobin dependent dosage
Trial: NCT05726227
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo will be administered subcutaneously once-weekly.
Trial: NCT05570786
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subdermal implant-bioabsorbable placebo pellet (cholesterol)
Trial: NCT06161441
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered IV Q3W
Trial: NCT05245058
Drug: SPH5030 tablets
FDA approved: no
EMA approved: no
PMDA approved: no
Description: SPH5030 tablets orally once or twice daily.
Trial: NCT06418789
Drug: High-dose chemotherapy (TI- 2 cycles, CE- 3 cycles )
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TI: Paclitaxel 200mg/m² on day 1, Ifosfamide 2000mg/m² daily from days 1 to 3 of 14-day cycle. G-CSF 10 micrograms/Kg SC daily day on days 6-14 day or until CD34 harvest. Leukapheresis will be performed starting on day 11 in case blood level of CD45+CD34+ above 20x10\^6/L is achieved.~CE: Carboplatin AUC=8 IV daily days -4 to -2, Etoposide 400mg/m\^2 IV daily days -4 to -2, autlologous stemm cell transplantation \>=2\*10\^6/Kg at day 0, GCSF support from day 4 until the recovery of neutrophils above 1\*10\^9/L.~Patients will receive two cycles of TI followed by 3 cycles of CE in case at least 6\*10\^6 CD34+ stem cells will be harvested.
Trial: NCT05536596
Drug: Melatonin 10 MG Oral Tablet
RxNorm normalized name: melatonin 10 MG Oral Tablet
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Group B will receive the pharmacology treatment with 10 mg Melatonin. One capsule orally at night for 60 days.
Trial: NCT05536596
Drug: Centrum
RxNorm normalized name: Centrum
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Groups A will receive the pharmacology treatment with 1.5 mg uridine triphosphate, 2.5 mg cytidine monophosphate and 1 mg hydroxycobalamin (Citoneuron). One capsule orally three times a day for 60 days as suggested by the manufacturer for patients with trauma - compressive peripheral neural disorders.
Trial: NCT04490096
Drug: [11C]-PBR28
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A dose of ≤ 20 mCi (approximate range for most studies is anticipated to be 5-20 mCi) of \[11C\]-PBR28 will be administered by IV injection to the patient under the direct supervision of a Nuclear Medicine Authorized User. A lesser activity may be injected if, in the opinion of a nuclear medicine authorized user complete imaging data could be generated.~Subjects will undergo an approximately 90 minute dynamic PET/CT scan over the brain starting at approximately the same time as the \[11C\]-PBR-28 injection. Scans will be acquired using a Philips PET/CT time-of-flight Ingenuity scanner (Philips Healthcare, Cleveland, OH, USA). At the end of the dynamic imaging the participant will be allowed to get off the scanner.
Trial: NCT05364164
Drug: CT-L01 12.5/1,000 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: FDC tablet, 2 tablets at a time, oral administration, dosing after high-fat meal
Trial: NCT05059262
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered orally
Trial: NCT06554301
Drug: placebo in treatment pulmonary aerterial hypertension
FDA approved: no
EMA approved: no
PMDA approved: no
Description: On the basis of background treatment, the control group was given 10 mg of placebo tablets orally once a day for 12 weeks.
Trial: NCT04980144
Drug: 0.1% hyaluronate
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 0.1% hyaluronate eye drops will be used to assess its usefulness in diabetic dry eye symptoms and compared to 3% Diquafosol tetrasodium eye drops.
Trial: NCT04753879
Drug: Capecitabine
RxNorm normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 1. Patients will receive treatment Day 1-7 and Day 15-21 of each cycle (28 days).~2. Capecitabine (500 mg) will be administered orally twice a day on days 1-7 and 15-21 of each cycle (28 days).~3. Other Name: Xeloda
Trial: NCT03123952
Drug: ABT-414
RxNorm normalized name: ABT-925
FDA approved: no
EMA approved: no
PMDA approved: no
Description: ABT-414 will be administered by intravenous infusion
Trial: NCT05737199
Drug: MK-3475 (pembrolizumab)
RxNorm normalized name: vitamin MK 7
FDA approved: no
EMA approved: no
PMDA approved: no
Description: MK-3475 (pembrolizumab) 200mg IV every 3 weeks \[Q3W\] Treated for 2 years (35 cycles), or until PD, unacceptable toxicity, or study withdrawal.
Trial: NCT05097261
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo (NaCl 0.9%) will be provided in the same type syringes and administered at the same infusion rate as the IMP (0.02 ml/kg/h to a maximum rate of 2.4 ml/h).
Trial: NCT00004114
Drug: cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT05866809
Drug: HK-660S
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered orally
Trial: NCT05866809
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered orally
Trial: NCT04670471
Drug: Remifentanil
RxNorm normalized name: Remifentanil
DrugBank: Remifentanil (DB00899)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Remifentanil is a commonly used opioid in anaesthetic practice. It is a potent and fast-acting analgesic.
Trial: NCT05868122
Drug: Acetaminophen/Naproxen Sodium Fixed Combination
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Fixed combination of Acetaminophen/Naproxen Sodium will be administered orally.
Trial: NCT05868122
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo will be administered orally.
Trial: NCT06722911
Drug: AG
RxNorm normalized name: AGP
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will receive nab-paclitaxel 125 mg/m\^2 followed by gemcitabine 1,000 mg/m\^2 as one intravenous infusion over 30-40 minutes on days 1 and 8 of every 21-day cycle. Patients will receive six treatment cycles unless there is radiologic evidence of disease recurrence and unacceptable toxicity.
Trial: NCT06723990
Drug: Neoadjuvant standard treatment for HER2+
FDA approved: no
EMA approved: no
PMDA approved: no
Description: NEOADJUVANT SETTING
Trial: NCT06723990
Drug: Adjuvant standard treatment for HER2+
FDA approved: no
EMA approved: no
PMDA approved: no
Description: ADJUVANT SETTING
Trial: NCT06523101
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Two participants in each dose level will be randomized to receive placebo in a double-blind fashion.
Trial: NCT04990804
Drug: Opioid Analgesic
RxNorm normalized name: OPIOID ANALGESICS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will be provided a prescription for low dose opioids for 5 days postoperatively (Hydrocodone/Acetaminophen 5/325mg or Oxycodone/Acetaminophen 5/325mg) to be taken every 6 hours as needed for pain. Refills may be provided (Hydrocodone/Acetaminophen 5/325mg or Oxycodone/Acetaminophen 5/325mg) if requested by the patient at the providers discretion. In addition, patients will also be prescribed Gabapentin 300mg q8 hours or Pregabalin 75mg twice daily and a muscle relaxer (Methocarbamol 750mg BID or Flexeril 5-10 mg TID) as needed for spasms. Alternative muscle relaxers (Metaxalone 800 mg TID or Tizanidine 2-6 mg TID) may be utilized if contraindications to methocarbamol and cyclobenzaprine exist.
Trial: NCT04990804
Drug: Opioid-Free Postoperative Pain Regimen
RxNorm normalized name: Anacin Aspirin Regimen
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will receive no opioids. Pain will be managed with Acetaminophen 1000mg q8 hours, Ketorolac 10mg every 6 hours (for 5 days), Gabapentin 300mg q8 hours or Pregabalin 75mg twice daily, and a muscle relaxer (Methocarbamol 750mg BID or Cyclobenzaprine 5-10 mg TID) all to be taken as scheduled for the first 2 weeks (except Ketorolac - 5 days) postoperatively as side effects permit. Other NSAIDS (Naprosyn 500 mg BID or Ibuprofen 800 mg TID) may be utilized if contraindications to Ketorolac exist. Famotidine (20mg BID) or Omeprazole (20mg daily) will be prescribed along with NSAIDS for GI prophylaxis. Alternative muscle relaxers (Metaxalone 800 mg TID or Tizanidine 2-6 mg TID) may be utilized if contraindications to methocarbamol and cyclobenzaprine exist.
Trial: NCT05086627
Drug: Capecitabine+Oxaliplatin
RxNorm normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Patients were treated with neoadjuvant chemotherapy with CapeOX (Capecitabine+Oxaliplatin).
Trial: NCT05432466
Drug: Placebo BID
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo for ACER-002
Trial: NCT06361108
Drug: YJ001 for Spray Use
RxNorm normalized name: Antibiotics for systemic use
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Granules for spray use; Preparation of Dosing Solution: Reconstitute with sterile water (50ml)
Trial: NCT06361108
Drug: Placebo of YJ001 for Spray Use
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Inactive Ingredient: Sterile water; Preparation of Dosing Solution: 50ml Sterile water
Trial: NCT05513807
Drug: Nicotinamide treatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 3g Nicotinamide orally (1g immediately pre transplant, then immediately 1g post-transplant after the recovery room and 1g 24 hours later)
Trial: NCT05513807
Drug: Placebo treatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 3g Placebo orally (1g immediately pre transplant, then immediately 1g post-transplant after the recovery room and 1g 24 hours later)
Trial: NCT05274893
Drug: SYHX2011 and Abraxane®
FDA approved: no
EMA approved: no
PMDA approved: no
Description: IV infusion, 260 mg/m\^2
Trial: NCT06204835
Drug: RD-Cy7 fluorophore
RxNorm normalized name: ethanol
DrugBank: Ethanol (DB00898)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Fluorophore targeting ITGA6 that is overexpressed in HCC cells
Trial: NCT05547516
Drug: Standard infusion chemotherapy
FDA approved: no
EMA approved: no
PMDA approved: no
Description: standard infusion chemotherapy (including gemcitabine, mitomycin, epirubicin, etc.), dissolved in 50mL normal saline or glucose, intravesical infusion chemotherapy, retained for 60min. Perfusion can be performed within 24 hours after surgery, and then once a week for a total of 8 times, and then once a month until 12 months after surgery
Trial: NCT04265105
Drug: Standard Preparation
FDA approved: no
EMA approved: no
PMDA approved: no
Description: inhaled SABA or Inhaled corticosteroid
Trial: NCT05213767
Drug: TQB2916 injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TQB2916 injection is a kind of Tumor necrosis factor receptor superfamily member 5 (CD40) agonist, which is a humanized immunoglobulinG2 (IgG2) monoclonal antibody targeting CD40. This product can bind to CD40 on target cells to activate downstream signaling pathways and generate anti-tumor immune responses. At the same time, it can promote the apoptosis of B-cell lymphoma Ramos cells.
Trial: NCT04969991
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral formulation matched to the oral varespladib tablet
Trial: NCT05338671
Drug: Local anesthetic
RxNorm normalized name: Local anesthetic
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will receive inferior alveolar nerve block injection following endodontic treatment.
Trial: NCT05769465
Drug: disease modifying treatments
RxNorm normalized name: Hongo Killer Treatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will be enrolled if exposed to nusinersen, risdiplam, onasemnogene abeparvovec
Trial: NCT06354816
Drug: Xylocaine 10% pump spray
FDA approved: no
EMA approved: no
PMDA approved: no
Description: First volunteers will undergo insertion of PIVC into the vessel of dorsum manus; 2-10 hours later: All volunteers will undergo insertion of PIVC into the forearm/cubita. Lidocaine spray 10 % serves as a local anesthesia is applied with a dispenser dispensing 0.1ml per pulse on the area of the skin, where the insertion of the PIVC is planned.~Exposure time is 2 min, timed with an hour glass; validated prior to the study by a stop watch. 0.5 ml (5 pulses) of 10% lidocaine spray (equals 50mg of lidocaine) are to be applied before insertion of a PIVC 18 Gauge.
Trial: NCT06354816
Drug: Saline solution isotonic 0.9% NaCl
FDA approved: no
EMA approved: no
PMDA approved: no
Description: First volunteers will undergo insertion of PIVC into the vessel at dorsum manus; 2-10 hours later: All volunteers will undergo insertion of PIVC into the forearm/cubita. Physiological saline solution serves as a placebo and is applied with a dispenser dispensing 0.1ml per pulse on the area of the skin, where the insertion of the PIVC is planned.~Exposure time is 2 min, timed with an hour glass; validated prior to the study by a stop watch. 0.5 ml (5 pulses) of 10% lidocaine spray (equals 50mg of lidocaine) are to be applied before insertion of a PIVC 18 Gauge.
Trial: NCT05083117
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: It is anticipated that inhalation of 1 mg Placebo solution up to 14 days will result in a relatively lower systemic exposure in COVID-19 patients on oxygen therapy compared to that in healthy participants as COVID-19 patients tend to have impaired lung function of diffusive, restrictive, obstructive, or mixed origins.
Trial: NCT05966688
Drug: SPR720
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Multiple oral doses of SPR720 capsules.
Trial: NCT05966688
Drug: Azithromycin
RxNorm normalized name: Azithromycin
DrugBank: Azithromycin (DB00207)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Multiple oral doses of azithromycin.
Trial: NCT03127267
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: treatment per os
Trial: NCT05499052
Drug: REKOVELLE®
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects must be treated according to the routine clinical practice and REKOVELLE® must be prescribed in accordance with the terms of the marketing authorisation of each participating country.~According to the label the REKOVELLE® dose should be based on a recent determination of body weight and a recent determination of Anti-Müllerian Hormone (AMH) (i.e. within the last 12 months) measured by the following diagnostic tests: ELECSYS AMH Plus immunoassay from Roche or alternatively the ACCESS AMH Advanced from Beckman Coulter or LUMIPULSE G AMH from Fujirebio.
Trial: NCT05404932
Drug: Aliquoted allogeneic donor plasma in patient's conjunctiva
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1-2 drops of allogenic aliquoted plasma to affected eye every 1-5 hours per day based on disease severity to be weaned down based on clinical response Administration period: Two to Six months. This may be repeated based on recurrence/worsening of conjunctivitis
Trial: NCT06518018
Drug: Immunotherapy
RxNorm normalized name: Dog immunotherapy extract
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Control Group receives the current standard of care for second-line treatment of advanced NSCLC. This regimen consists of a combination of immunotherapy and chemotherapy , both administered intravenously
Trial: NCT05448469
Drug: conventional analgesia
RxNorm normalized name: Analgesic Balm GRX
FDA approved: no
EMA approved: no
PMDA approved: no
Description: patients will receive combined general anesthesia and conventional analgesia
Trial: NCT06122311
Drug: N Acetylcysteine
FDA approved: no
EMA approved: no
PMDA approved: no
Description: N-acetylcysteine sachets 600 mg twice daily
Trial: NCT06565845
Drug: triple anti-tuberculosis drug
RxNorm normalized name: Mycobacterium tuberculosis
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients took oral rifampin (450 mg/day), isoniazid (300 mg/day), and ethambutol (15 mg/kg/day).
Trial: NCT04916236
Drug: RMC-4630
FDA approved: no
EMA approved: no
PMDA approved: no
Description: * SHP2-inhibitor~* Powder in capsule~* Administered on day 1 and day 2 of every week
Trial: NCT04783090
Drug: MT1013
FDA approved: no
EMA approved: no
PMDA approved: no
Description: bispecific peptide as a CaSR agonist and a functional OGP analogue
Trial: NCT04916236
Drug: LY3214996
FDA approved: no
EMA approved: no
PMDA approved: no
Description: * ERK inhibitor~* Powder in capsule~* Administered every day
Trial: NCT05245292
Drug: 3BNC117-LS
RxNorm normalized name: Emcor LS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intravenous infusion of 3BNC117-LS at 30 mg/kg
Trial: NCT05298449
Drug: HU-045
FDA approved: no
EMA approved: no
PMDA approved: no
Description: HU-045 is a medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults for a short period of time (temporary). It should be reconstituted with sterile, preservative-free 0.9% saline before use.~White powder
Trial: NCT05298449
Drug: Xeomin®
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Xeomin® is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults for a short period of time (temporary). It should be reconstituted with sterile, preservative-free 0.9% saline before use.
Trial: NCT05025956
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Fisetin appearance-matched microcrystalline cellulose placebo. 20 mg/kg taken for 8 days total.
Trial: NCT05716516
Drug: Estradiol
RxNorm normalized name: Estradiol
DrugBank: Estradiol acetate (DB13952)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Estradiol is a therapeutic option for the treatment of advanced ER+ breast cancer
Trial: NCT05317741
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects received matching placebo tablet orally on Day 1.
Trial: NCT06516419
Drug: Concentrated secretome Injection 2mL
RxNorm normalized name: gonorrheal urethral secretion human
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The secretome used in this research comes from mesenchymal stem cells from adipose tissue produced by IPT RSCM Stem Cell Medical Technology. The secretome produced by mesenchymal stem cells is collected, centrifuged to separate it from debris, and followed by filtration with a 0.22 μm pore filter to ensure sterility. Next, the concentration process is carried out using tangential flow filtration with the Spin-X UF 500® concentrator, packaged, and stored at -80 degrees Celsius. The product used is a sterile product, which is tested for sterility and total protein content. When it is to be used, the secretome is removed from the freezer, warmed (thawing), and injected into the patient according to a predetermined method.
Trial: NCT06516419
Drug: Triple Combination Cream
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1. Apply sunscreen SPF ≥30 in the morning on 2 knuckles~2. Apply triple combination cream (Refaquin) containing hydroquinone 40 mg, tretinoin 0.5 mg, and fluocinolone acetonide 0.1 mg at night all over the face except the area around the eyes, 1 fingertip unit (FTU) or 1 knuckle.
Trial: NCT04993157
Drug: FIA586
FDA approved: no
EMA approved: no
PMDA approved: no
Description: FIA586 capsule
Trial: NCT00463723
Drug: FK506 0.06% (eye drops)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT06522542
Drug: systematic therapy
RxNorm normalized name: Monistat Simple Therapy
FDA approved: no
EMA approved: no
PMDA approved: no
Description: All patients received systematic therapy including chemotherapy, targeted therapy or immune checkpoint inhibitor. We aims to investigate the impact of bleeding on the survival and treatment-related adverse events (TRAEs) of gastric cancer patients.
Trial: NCT05672836
Drug: Standard-of-Care
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Standard-of-Care medical therapy plus Enavogliflozin matching placebo
Trial: NCT05521984
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Standard of care
Trial: NCT05029141
Drug: CAHAG regimen
RxNorm normalized name: Anacin Aspirin Regimen Pill
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Chidamide 30mg orally twice every week for 2 weeks on days 1, 4, 8, 11, azacytidine 75mg/m2 intravenously daily for 7 days (d3-d9) and HAG regimen (cytarabine, 10 mg/m2 subcutaneously every 12 h on days 3-16; homoharringtonine, 1mg/m2 intravenously every day on days 3-16; and concurrent granulocyte colony-stimulating factor, 200mg/m2/day subcutaneously daily from days 2 to neutral granulocyte recovery. (when WBC \> 20×10E9/L, G-CSF paused).~One treatment cycle for 28 days, a total of 2 cycles. If the bone marrow assessment is MLFS on the 28th day in the first cycle, the second cycle of treatment will be started after NE\<1.0×10E9/L; if the delay exceeds 2 weeks, the patient needs to withdraw from the trial.
Trial: NCT05029141
Drug: Placebo regimen
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Chidamide 0mg orally twice every week for 2 weeks on days 1, 4, 8, 11, azacytidine 75mg/m2 intravenously daily for 7 days (d3-d9) and HAG regimen (cytarabine, 10 mg/m2 subcutaneously every 12 h on days 3-16; homoharringtonine, 1mg/m2 intravenously every day on days 3-16; and concurrent granulocyte colony-stimulating factor, 200mg/m2/day subcutaneously daily from days 2 to neutral granulocyte recovery. (when WBC \> 20×10E9/L, G-CSF paused).~One treatment cycle for 28 days, a total of 2 cycles. If the bone marrow assessment is MLFS on the 28th day in the first cycle, the second cycle of treatment will be started after NE\<1.0×10E9/L; if the delay exceeds 2 weeks, the patient needs to withdraw from the trial.