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

This study is currently recruiting participants.
Verified May 2016 by Jiong HU, Shanghai Jiao Tong University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT01987297
First Posted: November 19, 2013
Last Update Posted: May 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Peking University People's Hospital
Information provided by (Responsible Party):
Jiong HU, Shanghai Jiao Tong University School of Medicine
  Purpose
In this prospective randomized study for patients with newly diagnosed acute promyelocytic leukemia, patients will be randomized into two groups which received retinoic acid and arsenic trioxide based treatment versus retinoic acid and chemotherapy based regimen.

Condition Intervention Phase
Acute Promyelocytic Leukemia Drug: ATRA+arsenic Drug: ATRA+chemo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Retinoic Acid,Arsenic Trioxide and Chemotherapy for Newly-diagnosed Acute Promyelocytic Leukemia: Chinese National Multi-center Randomized Study

Resource links provided by NLM:


Further study details as provided by Jiong HU, Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • disease free survival [ Time Frame: 3 year ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 3 year ]

Other Outcome Measures:
  • arsenic associated toxicity [ Time Frame: 5 year ]

Estimated Enrollment: 680
Study Start Date: October 2012
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ATRA+Arsenic
Patients received treatment with retinoic acid and arsenic trioxide
Drug: ATRA+arsenic
experimental
Other Name: retinoic acid + arsenic trioxide
Active Comparator: ATRA+chemo
patients recieved retinoic acid and chemotherapy with idarubicin or daunorubicin
Drug: ATRA+chemo
control
Other Name: retinoic acid + idarubicin or daunorubicin

Detailed Description:
In this prospective randomized study for patients with newly diagnosed acute promyelocytic leukemia. For induction, all patients will be randomized into two groups which received treatment composed of retinoic acid combined with arsenic trioxide versus retinoic acid combined with chemotherapy. For consolidation, the experimental group recieved 2 cycles of ATRA+arsenic and control group recieved two cycles of ATRA+idarubicin or daunorubicin. After consolidation, all patients achieved molecular remission will recieved 5 cycles of maintenance treatment with ATRA and arsenic. In case of intermediate or high-risk disease, cytarabine will be add for consolidation.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Informed consent

Exclusion Criteria:

  • Relapsed patients
  • Known history of arsenic allergy
  • QT interval >450ms
  • Other malignanct disease
  • Pregnant patients
  • Patients with mental illness
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987297


Contacts
Contact: Jiong HU hujiong@medmail.com.cn

Locations
China
Department of Hematology Recruiting
Shanghai, China, 200025
Contact: Jiong HU       hujiong@medmail.com.cn   
Principal Investigator: Jun-min Li, M.D         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Peking University People's Hospital
Investigators
Principal Investigator: Jun-min Li, M.D Department of Hematology, Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
  More Information

Responsible Party: Jiong HU, Deaprtment of Hematology, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01987297     History of Changes
Other Study ID Numbers: APL2012
First Submitted: December 6, 2012
First Posted: November 19, 2013
Last Update Posted: May 10, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jiong HU, Shanghai Jiao Tong University School of Medicine:
arsenic
acute promyelocytic leukemia
outcome

Additional relevant MeSH terms:
Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Daunorubicin
Idarubicin
Arsenic trioxide
Tretinoin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Keratolytic Agents
Dermatologic Agents