Combined Retinoic Acid,Arsenic Trioxide and Chemo for Newly-diagnosed APL

Brief Title

Combined Retinoic Acid,Arsenic Trioxide and Chemo for Newly-diagnosed APL

Official Title

Combined Retinoic Acid,Arsenic Trioxide and Chemotherapy for Newly-diagnosed Acute Promyelocytic Leukemia: Chinese National Multi-center Randomized Study

Brief Summary

      In this prospective randomized study for patients with newly diagnosed acute promyelocytic
      leukemia, patients will be randomized (1:1) into two groups which receive retinoic acid and
      arsenic trioxide based treatment versus retinoic acid and chemotherapy based regimen.
    

Detailed Description

      The study is carried out based on Sanz risk stratification of newly-diagnosed APL patients
      into low-, intermediate- and high-risk groups, and all of them will receive ATRA and ATO as
      induction therapy (ATRA 25 mg/m2 per day orally + ATO 0.16mg/kg intravenously daily).
      Anthracycline is added to both high-risk groups or intermediate-risk group with
      hyperleukocytosis developed during induction therapy but not in low-risk groups.

      After achieving CR, patients enter into consolidation therapy. Low-risk patients receive
      either 2 courses of ATRA plus ATO (Experimental group) or 2 courses of ATRA plus
      anthracycline chemotherapy (Control group). Intermediate-risk patients receive either 3
      courses of ATRA plus ATO (Experimental group) or 2 courses of ATRA plus anthracycline
      chemotherapy (Control group). Patients of high-risk disease receive 2 courses of ATRA plus
      ATO and anthracycline and 1 course of ATRA plus ATO treatment (Experimental group) or 2
      courses of ATRA plus anthracycline and cytarabine and 1 course of ATRA plus mid-dose
      cytarabine (Control group).

      After consolidation therapy, patients with molecular complete remission (mCR) enter into
      maintenance therapy. Low- and intermediate-risk patients receive 3 cycles of ATRA and ATO
      sequential treatment, while those of high-risk receive 5 cycles of ATRA, ATO and methotrexate
      (MTX) treatment.

      For low- and intermediate-risk patients who fail to achieve mCR after consolidation therapy,
      3 courses of consolidation therapy of high-risk group will be given with cross-over (i.e.
      patients in Experimental group received the therapy of Control group, and patients in Control
      group received the therapy of Experimental group). If patients still fail to achieve mCR,
      together with high-risk group who fail to achieve mCR after consolidation therapy will be
      withdrawn from the study and proceed to salvage treatment.
    

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Disease free survival (DFS)

Secondary Outcome

 Complete remission (CR) rate

Condition

Acute Promyelocytic Leukemia

Intervention

ATRA+Arsenic

Study Arms / Comparison Groups

 ATRA+Arsenic

Description:  All low- and intermediate-risk patients receive retinoic acid and arsenic trioxide based consolidation. High-risk patients receive ATRA+Arsenic+Anthracycline consolidation.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

738

Start Date

June 2012

Completion Date

December 31, 2020

Primary Completion Date

December 31, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Newly-diagnosed patients with acute promyelocytic leukemia via cytogenetics and
             molecular assay

          -  Age: 18-65

          -  Hepatic/renal function: Bil≤35μmol/L，AST/ALT less than 2Xnormal range, Cr 150μmol/L

          -  Normal cardial function

          -  ECOG：0-4

          -  Informed consent

        Exclusion Criteria:

          -  QTC interval >450ms

          -  Pregnant or breast feeding patients

          -  Patients with drug addiction or mental illness

          -  Patients documented of CNS infiltration at diagnosis

          -  Patients with severe heart disease (acute myocardial infarction or heart failure)

          -  Patients with concurrent active malignancy, tuberculosis or HIV infection

          -  Patients with contraindication or allergy to anthracyclines or other agent in the
             protocol

          -  Patients enrolled in other clinical trials

          -  Patients not apply to the study protocol
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Jun-min Li, M.D, , 

Location Countries

China

Location Countries

China

NCT ID

NCT01987297

Organization ID

APL2012

Responsible Party

Principal Investigator

Study Sponsor

Shanghai Jiao Tong University School of Medicine

Collaborators

 Tang-Du Hospital

Study Sponsor

Jun-min Li, M.D, Principal Investigator, Department of Hematology, Rui Jin Hospital, Shanghai JiaoTong University School of Medicine

Verification Date

August 2019