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

Sponsor
The First Affiliated Hospital of Soochow University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04446806
Collaborator
(none)
100
1
24
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Prospective Single Center Study of Prevention and Treatment of Differentiation Syndrome in Patients With Acute Promyelocytic Leukemia
Actual Study Start Date :
Jun 1, 2019
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
May 31, 2021

Outcome Measures

Primary Outcome Measures

  1. complete remission rate [during the induction treatment]

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

  2. incidence and severity of differentiation syndrome [during the induction treatment]

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

Secondary Outcome Measures

  1. overall survival [from the day of first patient treatment up to 36 months after the last patient's enrollment]

    from the date of inclusion to date of death, irrespective of cause

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 First Affiliated Hospital, Soochow University Suzhou Jiangsu China 215000

Sponsors and Collaborators

  • The First Affiliated Hospital of Soochow University

Investigators

  • Study Chair: Qian Wu, First Affiliated Hospital, Soochow University Suzhou, Jiangsu, China, 215000

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier:
NCT04446806
Other Study ID Numbers:
  • APL-01
First Posted:
Jun 25, 2020
Last Update Posted:
Jun 25, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 25, 2020