Clinical trial · Interventional
Prevention and Treatment of Differentiation Syndrome in Patients With Acute Promyelocytic Leukemia
A Prospective Single Center Study of Prevention and Treatment of Differentiation Syndrome in Patients With Acute Promyelocytic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Safety and Efficacy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ruxolitinib | Drug | Ruxolitinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- complete remission rate
- timeFrame
- during the induction treatment
- description
- complete remission rate after treated by the induction regimen with ATRA and Arsenite
- measure
- incidence and severity of differentiation syndrome
- timeFrame
- during the induction treatment
- description
- All symptoms and signs associated to DS should be paid closely attention to.
Secondary outcomes (1)
- measure
- overall survival
- timeFrame
- from the day of first patient treatment up to 36 months after the last patient's enrollment
- description
- from the date of inclusion to date of death, irrespective of cause
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical diagnosis of primary acute promyelocytic leukemia. * ECOG score≤3. * Must be able to understand and willing to participate in the study and sign the informed consent. Exclusion Criteria: * Refractory/secondary acute promyelocytic leukemia. * Severe complications such as myocardial infarction, chronic cardiac insufficiency, hepatic failure, renal insufficiency, etc. * Clinically uncontrolled active infections. * Malignant tumors with other progresses. * Ecg: QT interval \> 450 ms. * Allergic to arsenic agent. * Pregnant or lactating women.
References
Publications (0)
Data not yet available