Trial record 18 of 128 for:    ACUTE PROMYELOCYTIC LEUKEMIA

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Collaborators:
Shanghai First People's Hospital
Peking University People's Hospital
Information provided by (Responsible Party):
Jiong HU, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01987297
First received: December 6, 2012
Last updated: November 12, 2013
Last verified: November 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • disease free survival [ Time Frame: 3 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • arsenic associated toxicity [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 680
Study Start Date: October 2012
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2015 (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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 First People's Hospital
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

No publications provided

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
Study First Received: December 6, 2012
Last Updated: November 12, 2013
Health Authority: China: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 23, 2014