Prevention and Treatment of Differentiation Syndrome in Patients With Acute Promyelocytic Leukemia

NCT04446806 | Unknown Phase 4

• 1 other identifier: APL-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Safety and Efficacy

Outcome Measures

Primary Outcomes (2)

• complete remission rate

  complete remission rate after treated by the induction regimen with ATRA and Arsenite

  during the induction treatment

• incidence and severity of differentiation syndrome

  All symptoms and signs associated to DS should be paid closely attention to.

  during the induction treatment

Secondary Outcomes (1)

• overall survival

  from the day of first patient treatment up to 36 months after the last patient's enrollment

Interventions

Ruxolitinib DRUG

Ruxolitinib as second treatment in patients with severe DS failed in responding to hormone.Furthermore

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

First Affiliated Hospital, Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Interventions

ruxolitinib

Study Officials

• Qian Wu

  First Affiliated Hospital, Soochow University Suzhou, Jiangsu, China, 215000

  STUDY CHAIR

Central Study Contacts

Suning Chen

CONTACT

8613814881746; chensuning@sina.com

Qian Wu

CONTACT

8613656205608; 42732890@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2020
• First Posted: June 25, 2020
• Study Start: June 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: May 31, 2021
• Last Updated: June 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)