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Trial record 29 of 33 for:    "Acute Promyelocytic Leukemia" | "Arsenic trioxide"

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

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.

Condition or disease Intervention/treatment Phase
Childhood Acute Promyelocytic Leukemia Drug: ATO Drug: RIF Drug: ATRA Drug: mitoxantrone Drug: Ara-C Drug: MTX Drug: 6MP Other: intrathecal injection Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter and Randomized Prospective Study for Improving the Outcome of Childhood Acute Promyeloid Leukemia
Study Start Date : September 2011
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
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.

Drug: ATO
Given IV
Other Names:
  • As2O3
  • arsenic trioxide

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

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.

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




Primary Outcome Measures :
  1. event-free survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02200978


Locations
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China, Guangdong
The First Affiliated Hospital of Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Xue-Qun Luo, professor       L-xuequn@126.com   
Principal Investigator: Xue-Qun Luo, professor         
Sponsors and Collaborators
South China Children's Leukemia Group
Investigators
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Principal Investigator: Xue-Qun Luo, professor First Affiliated Hospital, Sun Yat-Sen University

Publications:

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Responsible Party: South China Children's Leukemia Group
ClinicalTrials.gov Identifier: NCT02200978     History of Changes
Other Study ID Numbers: 2010001
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
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Arsenic Trioxide
Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Dexamethasone
Cytarabine
Mitoxantrone
Mercaptopurine
Tretinoin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors