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Trial record 33 of 144 for:    "Acute promyelocytic leukemia"

A Study for Improving the Outcome of Childhood Acute Promyeloid Leukemia

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ClinicalTrials.gov Identifier: NCT02200978
Recruitment Status : Recruiting
First Posted : July 25, 2014
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
South China Children's Leukemia Group

Tracking Information
First Submitted Date  ICMJE February 8, 2014
First Posted Date  ICMJE July 25, 2014
Last Update Posted Date May 16, 2018
Study Start Date  ICMJE September 2011
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2014)
event-free survival [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02200978 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2014)
hospitalization cost [ Time Frame: 2 years ]
The cost mainly includes the fees of hospital bed, drugs, therapies and blood products. Time frame: from the beginning of induction therapy to the end of maintenance treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study for Improving the Outcome of Childhood Acute Promyeloid Leukemia
Official Title  ICMJE A Multicenter and Randomized Prospective Study for Improving the Outcome of Childhood Acute Promyeloid Leukemia
Brief Summary Outcome of acute promyelocytic leukemia (APL) has greatly improved since the introduction of all-trans-retinoic acid (ATRA). Treatment with ATRA and anthracycline-based chemotherapy (ATRA + chemotherapy) decreases relapses of the disease as well as early hemorrhagic deaths. Nowadays patients with APL have an event-free survival (EFS) of up to 80%. However, there remains a subset of the patients in whom the disease relapses. Recently, a randomized prospective study showed that the addition of ATO to "ATRA + chemotherapy" treatment protocol had a significantly higher EFS in patients with APL than those treated with "ATRA + chemotherapy" protocol. The patients treated with "ATO + ATRA + chemotherapy" had a five years EFS of 89.2%. Moreover, a recent study showed that Indigo naturalis formula (RIF), a traditional Chinese medicine with tetraarsenic tetrasulfide (As4S4), indirubin, and tanshinone IIA as major active ingredients, yielded synergy in the treatment of a murine APL model in vivo and in the induction of APL cell differentiation in vitro . It is about 20 years since RIF was used to treat ALP in China. Clinical studies showed that this agent was effective against APL. Compared to ATO, RIF is relatively inexpensive and can be taken orally, resulting in reducing the number of hospital days and the treatment cost. However, there is no report comparing treatment outcomes of "ATO + ATRA + chemotherapy" and "RIF + ATRA + chemotherapy" protocols in children with APL so far. For this purpose, therefore, investigators are going to conduct a multicenter and randomized prospective study in children with APL.
Detailed Description

OBJECTIVES:

  • Determine the safety and efficacy of "ATO/RIF + ATRA + less intensive chemotherapy" protocol in children with acute promyelocytic leukemia (APL).
  • Compare the safety,efficacy and treatment cost of "RIF + ATRA + less intensive chemotherapy" with "ATO + ATRA + less intensive chemotherapy" protocol in children with APL. Determine if ATO can be substituted by RIF.

OUTLINE: This is a multicenter and randomized prospective study.

PROJECTED ACCRUAL: A total of 162 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Childhood Acute Promyelocytic Leukemia
Intervention  ICMJE
  • Drug: ATO
    Given IV
    Other Names:
    • As2O3
    • arsenic trioxide
  • Drug: RIF
    Given orally
    Other Name: Realgar-Indigo naturalis formula
  • Drug: ATRA
    Given orally
    Other Name: all-trans retinoic acid
  • Drug: mitoxantrone
    Given IV
    Other Name: novantrone
  • Drug: Ara-C
    Given IV
    Other Names:
    • cytarabine
    • cytosine arabinoside
  • Drug: MTX
    Given orally
    Other Name: methotrexate
  • Drug: 6MP
    Given orally
    Other Name: mercaptopurine
  • Other: intrathecal injection
    Ara-C and dexamethasone
    Other Name: IT
Study Arms  ICMJE
  • Active Comparator: ATO and chemotherapy

    Induction:

    ATRA 25mg/m2 d1-CR ≯42 days; ATO 0.16mg/kg d5-CR ≯42 days; mitoxantrone (MA) 10mg/m2 d3, or 7mg/m2 d2-4 (high risk).

    Consolidation 1:

    ATRA 25mg/m2 d1-15; MA 10mg/m2 d1-2; Intrathecal injection (IT):Ara-C 15mg (age < 1 year), or 20 mg (1-3 years), or 30 mg ( > 3 years), dexamethasone 2mg.

    Consolidation 2:

    ATRA 25mg/m2 d1-15; ATO 0.16mg/kg d1-15; Ara-C 1g/m2 q12h d1-2 (high risk); IT.

    Consolidation 3:

    ATRA 25mg/m2 d1-15; ATO 0.16mg/kg d1-15; MA 10mg/m2 d1; Ara-C 1g/m2 q12h d1-2 (high risk); IT.

    Maintenance:

    ① ATO 0.16mg/kg.d w1-2; ATRA 25mg/m2.d w1-2; MTX 20mg/m2 qw w3-12; 6MP 50mg/m2 qn w3-12. ② ATRA 25mg/m2.d w1-2; MTX 20mg/m2 qw w3-12; 6MP 50mg/m2 qn w3-12. Rotation between ① and ② until the end of maintenance.

    Interventions:
    • Drug: ATO
    • Drug: ATRA
    • Drug: mitoxantrone
    • Drug: Ara-C
    • Drug: MTX
    • Drug: 6MP
    • Other: intrathecal injection
  • Experimental: RIF and chemotherapy

    Induction:

    ATRA 25mg/m2 d1-CR ≯42 days; RIF 0.135/kg d5-CR ≯42 days; mitoxantrone (MA) 10mg/m2 d3, or 7mg/m2 d2-4 (high risk).

    Consolidation 1:

    ATRA 25mg/m2 d1-15; MA 10mg/m2 d1-2; Intrathecal injection (IT):Ara-C 15mg (age < 1 year), or 20mg (age 1-3 years), or 30mg (age > 3 years), dexamethasone 2mg.

    Consolidation 2:

    ATRA 25mg/m2 d1-15; RIF 0.135/kg d1-15; Ara-C 1g/m2 q12h d1-2 (high risk); IT.

    Consolidation 3:

    ATRA 25mg/m2 d1-15; RIF 0.135/kg d1-15; MA 10mg/m2 d1; Ara-C 1g/m2 q12h d1-2 (high risk); IT.

    Maintenance:

    ① RIF 0.135/kg.d w1-2; ATRA 25mg/m2.d w1-2; MTX 20mg/m2 qw w3-12; 6MP 50mg/m2 qn w3-12. ② ATRA 25mg/m2.d w1-2; MTX 20mg/m2 qw w3-12; 6MP 50mg/m2 qn w3-12. Rotation between ① and ② until the end of maintenance treatment.

    Interventions:
    • Drug: RIF
    • Drug: ATRA
    • Drug: mitoxantrone
    • Drug: Ara-C
    • Drug: MTX
    • Drug: 6MP
    • Other: intrathecal injection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 30, 2018)
162
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2014)
250
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients less than 16 years old with newly diagnosed PML-RARa positive acute promyelocytic leukemia.

Exclusion Criteria:

  • Patients who have coma, convulsion or paralysis due to intracranial hemorrhage or central nervous system leukemia at diagnosis.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02200978
Other Study ID Numbers  ICMJE 2010001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party South China Children's Leukemia Group
Study Sponsor  ICMJE South China Children's Leukemia Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xue-Qun Luo, professor First Affiliated Hospital, Sun Yat-Sen University
PRS Account South China Children's Leukemia Group
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP