Safety and Efficacy Clinical Trial
Official title:
A Prospective Single Center Study of Prevention and Treatment of Differentiation Syndrome in Patients With Acute Promyelocytic Leukemia
With the introduction of all-trans-retinoic acid (ATRA) and arsenic,the outcome of patients with acute promyelocytic leukemia (APL)has been improved considerably over the last decades.However，early deaths (EDs), mainly due to APL-specific coagulopathy, differentiation syndrome (DS)emerge as a major threat to APL patients.We observe and evaluate the effectivity of induction therapy in patients with APL. Administrate intravenous dexamethasone to prevent or preemptive treat DS. Assess the efficacy and safety of ruxolitinib as second treatment in patients with severe DS with no respond to dexamethasone.Furthermore，the changes of spectrum of cytokines are monitered to find the relationship between the cytokines and the severity of DS.
Adults ages 18-75 with primary acute promyelocytic leukemia.
Design:
The induction therapy with ATRA 25mg/m2/d and ATO 10mg/kg/d should be started as soon as the
diagnosis of APL confirmed.
Intravenous dexamethasone at a dose of 5-20 mg daily must be started if the WBC count greater
than 5e+9/L (before or during the treatment with ATRA) as prevention or preemptive therapy of
DS.
Idarubicin (4-10 mg/m2 /d*3d) and hydroxyurea（1.0-3.0g/d）can be given as leukocyte lowering
therapy which may lessen the risk of DS.
When the progression of clinical symptoms of DS with no response to dexamethasone,ATRA must
be stopped and ruxolitinib (5-20mg /d) should be administrated to reduce the production of
cytokines.
Participants should stay in the hospital during the treatment for about 4 weeks.
The changes of spectrum of cytokines are monitored to discover the potential relationship
between the cytokines and the severity of DS.
Participants will visit every 1 months after CR for 3 years.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04994210 -
Sintilimab in Combination With Chidamide in Newly Diagnosed ENKTCL
|
Phase 2 | |
| Terminated |
NCT05247957 -
NKG2D CAR-NK Cell Therapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia
|
N/A | |
| Completed |
NCT04621123 -
Plasma for Early Treatment in Non-hospitalised Mild or Moderate COVID-19 Patients
|
Phase 2 | |
| Recruiting |
NCT05140616 -
Study of Chidamide for Steroid-resistant/Steroid-dependent Severe cGVHD
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05349552 -
Safety and Efficacy of SBRT in the Treatment of Thoracic Malignant Tumors at Different Sites
|
||
| Completed |
NCT03820596 -
Sintilimab in Combination With Chidamide in Refractory and Relapsed ENKTCL
|
Phase 1/Phase 2 | |
| Completed |
NCT02018250 -
Study to Evaluate the Safety of a New Oxime, MMB4 DIMETHANESULFONATE (DMS)
|
Phase 1 | |
| Recruiting |
NCT05556889 -
Safety and Analgesic Efficacy of a Modified Auriculotemporal Nerve Block
|
N/A | |
| Not yet recruiting |
NCT06244537 -
Study on the Safety and Efficacy of MR-Linac Technique in Patients With Unresectable Locally Advanced Colon Cancer
|
N/A | |
| Recruiting |
NCT03455972 -
Study of T Cells Targeting CD19/BCMA (CART-19/BCMA) for High Risk Multiple Myeloma Followed With Auto-HSCT
|
Phase 1/Phase 2 | |
| Completed |
NCT04785170 -
Clinical Study to Evaluate Safety and Efficacy of Amino Acid in Healthy Individuals
|
N/A | |
| Recruiting |
NCT04677452 -
Dose Exploration Study OF JWCAR129, BCMA-Targeted CART for RRMM
|
Phase 1 | |
| Completed |
NCT01305044 -
The HEALS Project - Health Education and Active Living for Surviving Seniors
|
Phase 2 | |
| Active, not recruiting |
NCT04646590 -
A Phase III Clinical Trial to Determine the Safety and Efficacy of ZF2001 for Prevention of COVID-19
|
Phase 3 | |
| Recruiting |
NCT05021276 -
Basiliximab Combined With Ruxolitinib as Second-line Treatment of Grade 3-4 Steroid-resistant aGVHD
|
Phase 4 | |
| Not yet recruiting |
NCT05008666 -
Induction Chemotherapy Sequential Sintilimab Combined With Dual Epigenetic Drugs for ENKTL-HLH
|
Phase 2 | |
| Recruiting |
NCT06066840 -
Vedolizumab, Anti-CD25 Antibody, Rapid Reduction of Glucocorticoids for SR-aGVHD With Gastrointestinal Involvement
|
Phase 4 | |
| Active, not recruiting |
NCT04852068 -
A Clinical Trial of Freeze-dried Human Rabies Vaccine (Vero Cells)
|
Phase 3 |