- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02200978
A Study for Improving the Outcome of Childhood Acute Promyeloid Leukemia
A Multicenter and Randomized Prospective Study for Improving the Outcome of Childhood Acute Promyeloid Leukemia
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510080
- The First Affiliated Hospital of Sun Yat-sen University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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. |
Given IV
Other Names:
Given orally
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given orally
Other Names:
Given orally
Other Names:
Ara-C and dexamethasone
Other Names:
|
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. |
Given orally
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given orally
Other Names:
Given orally
Other Names:
Ara-C and dexamethasone
Other Names:
Given orally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
event-free survival
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Xue-Qun Luo, professor, First Affiliated Hospital, Sun Yat-Sen University
Publications and helpful links
General Publications
- Shen ZX, Shi ZZ, Fang J, Gu BW, Li JM, Zhu YM, Shi JY, Zheng PZ, Yan H, Liu YF, Chen Y, Shen Y, Wu W, Tang W, Waxman S, De The H, Wang ZY, Chen SJ, Chen Z. All-trans retinoic acid/As2O3 combination yields a high quality remission and survival in newly diagnosed acute promyelocytic leukemia. Proc Natl Acad Sci U S A. 2004 Apr 13;101(15):5328-35. doi: 10.1073/pnas.0400053101. Epub 2004 Mar 24.
- Hu J, Liu YF, Wu CF, Xu F, Shen ZX, Zhu YM, Li JM, Tang W, Zhao WL, Wu W, Sun HP, Chen QS, Chen B, Zhou GB, Zelent A, Waxman S, Wang ZY, Chen SJ, Chen Z. Long-term efficacy and safety of all-trans retinoic acid/arsenic trioxide-based therapy in newly diagnosed acute promyelocytic leukemia. Proc Natl Acad Sci U S A. 2009 Mar 3;106(9):3342-7. doi: 10.1073/pnas.0813280106. Epub 2009 Feb 18.
- Wang L, Zhou GB, Liu P, Song JH, Liang Y, Yan XJ, Xu F, Wang BS, Mao JH, Shen ZX, Chen SJ, Chen Z. Dissection of mechanisms of Chinese medicinal formula Realgar-Indigo naturalis as an effective treatment for promyelocytic leukemia. Proc Natl Acad Sci U S A. 2008 Mar 25;105(12):4826-31. doi: 10.1073/pnas.0712365105. Epub 2008 Mar 14.
- Xiang Y, Wang XB, Sun SJ, Guo AX, Wei AH, Cheng YB, Huang SL. [Compound huangdai tablet as induction therapy for 193 patients with acute promyelocytic leukemia]. Zhonghua Xue Ye Xue Za Zhi. 2009 Jul;30(7):440-2. Chinese.
- Luo XQ, Ke ZY, Huang LB, Guan XQ, Zhang YC, Zhang XL. Improved outcome for Chinese children with acute promyelocytic leukemia: a comparison of two protocols. Pediatr Blood Cancer. 2009 Sep;53(3):325-8. doi: 10.1002/pbc.22042.
- Liao LH, Chen YQ, Huang DP, Wang LN, Ye ZL, Yang LH, Mai HR, Li Y, Liang C, Luo JS, Wang LN, Luo XQ, Tang YL, Zhang XL, Huang LB. The comparison of plasma arsenic concentration and urinary arsenic excretion during treatment with Realgar-Indigo naturalis formula and arsenic trioxide in children with acute promyelocytic leukemia. Cancer Chemother Pharmacol. 2022 Jul;90(1):45-52. doi: 10.1007/s00280-022-04449-9. Epub 2022 Jun 27.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Leukemia
- Leukemia, Promyelocytic, Acute
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Dermatologic Agents
- Keratolytic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Arsenic Trioxide
- Cytarabine
- Methotrexate
- Mitoxantrone
- Mercaptopurine
- Tretinoin
Other Study ID Numbers
- 2010001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Childhood Acute Promyelocytic Leukemia
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedMyeloid Neoplasm | Childhood Acute Promyelocytic Leukemia With PML-RARAUnited States, Canada, Puerto Rico
-
National Cancer Institute (NCI)CompletedUntreated Adult Acute Myeloid Leukemia | Adult Acute Promyelocytic Leukemia (M3) | Childhood Acute Promyelocytic Leukemia (M3) | Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) | Untreated Childhood Acute Myeloid Leukemia and Other Myeloid MalignanciesUnited States
-
National Cancer Institute (NCI)TerminatedSecondary Acute Myeloid Leukemia | Childhood Acute Myeloblastic Leukemia With Maturation (M2) | Childhood Acute Promyelocytic Leukemia (M3) | Recurrent Childhood Acute Lymphoblastic Leukemia | Recurrent Childhood Acute Myeloid LeukemiaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedSecondary Acute Myeloid Leukemia | Childhood Acute Myeloid Leukemia in Remission | Childhood Acute Lymphoblastic Leukemia in Remission | Recurrent Childhood Acute Lymphoblastic Leukemia | Recurrent Childhood Acute Myeloid Leukemia | Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 and other conditionsUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedAdult Acute Promyelocytic Leukemia (M3) | Childhood Acute Promyelocytic Leukemia (M3) | Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) | Adult Acute Myeloid LeukemiaUnited States
-
National Cancer Institute (NCI)CompletedJuvenile Myelomonocytic Leukemia | Recurrent Disease | Recurrent Childhood Acute Lymphoblastic Leukemia | Recurrent Childhood Acute Myeloid Leukemia | Childhood Chronic Myelogenous Leukemia, BCR-ABL1 Positive | Childhood Solid Neoplasm | Chronic Myelogenous Leukemia, BCR-ABL1 Positive | Philadelphia... and other conditionsUnited States, Canada
-
German AML Cooperative GroupUnknownRelapsed Acute Promyelocytic Leukemia | Refractory Acute Promyelocytic LeukemiaGermany
-
National Cancer Institute (NCI)CompletedChildhood Acute Promyelocytic Leukemia (M3) | Recurrent Childhood Acute Lymphoblastic Leukemia | Recurrent Childhood Acute Myeloid Leukemia | Blastic Phase Chronic Myelogenous LeukemiaUnited States
-
Christian Medical College, Vellore, IndiaUnknownRelapsed Acute Promyelocytic LeukemiaIndia
-
Instituto Nacional de Cancerologia de MexicoCompletedPromyelocytic Leukemia, AcuteMexico
Clinical Trials on ATO
-
Syros PharmaceuticalsSuspendedAcute Promyelocytic LeukemiaUnited States
-
Emory UniversityNational Cancer Institute (NCI); Teva Pharmaceuticals USA; CephalonCompletedLung Cancer | Carcinoma, Small Cell | Pulmonary Neoplasms | Pulmonary Cancer | Cancer of LungUnited States
-
Gruppo Italiano Malattie EMatologiche dell'AdultoRecruitingAcute Promyelocytic LeukemiaItaly
-
Yang LiRecruiting
-
Yang LiRuijin HospitalRecruitingPediatric Cancer | Li-Fraumeni Syndrome | p53 MutationsChina
-
Tehran University of Medical SciencesCompletedLeukemia, Myeloid, AcuteIran, Islamic Republic of
-
Grupo Argentino de Tratamiento de la Leucemia AgudaRecruiting
-
Ruijin HospitalRecruitingP53 Mutation | Myeloid Malignancy | MDS | AmlChina
-
Jonsson Comprehensive Cancer CenterCelgene Corporation; CTI BioPharmaTerminatedMyelodysplastic Syndromes | LeukemiaUnited States
-
First Affiliated Hospital Xi'an Jiaotong UniversityRecruitingAcute Myeloid LeukemiaChina