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CCCG-APL-2017 protocol based multi-center trial of childhood acute promyelocytic leukemia

CCCG-APL-2017 protocol based multi-center trial of childhood acute promyelocytic leukemia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-OIC-16010014
Enrollment
Unknown
Registered
2016-11-25
Start date
2017-03-09
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute promyelocytic leukemia

Interventions

APL:Realgar-indigo naturalisformular

Sponsors

Tianjin Hematonosis Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 16 Years

Inclusion criteria

Inclusion criteria: Patients should meet the following three requirements at the same time: 1. Diagnosis of acute promyelocytic leukemia by morphology; 2. PML-RARA fusion gene positive and /or carry chromosomal translocation t(15;17); 3. Aged 20 days to 18 years.

Exclusion criteria

Exclusion criteria: 1. Reccurence or secondary neoplasmia; 2. Secondary to immunodeficiency disease,bone marrow failure or other congenital defect; 3. Participants with prior therapy of ATRA or arsenic over 1 week; 4. Participants with prior therapy of cytotoxic agents; 5. Participants with complications not secondary to APL and researchers concluded that need to rule out; 6. Participants without Guardian Informed Consent Agreement.

Design outcomes

Primary

MeasureTime frame
Bone marrow morphology;Bone marrow fusion gene test;event free survival;overall survival;

Secondary

MeasureTime frame
Bone marrow Karyotype;FISH translocations;Peripheral blood blast cell count;Bone marrow immunophenotype;Electrocardiogram;blood Electrolytes;Blood chemistry;Coagulation;Drug monitoring;Hematology;Cerebralspinal Fluid test;Toxicity;Surgical cases due to complications;Urinalysis;Stool test;

Countries

China

Contacts

Public ContactZHU Xiaofan

Tianjin Hematonosis Hospital

xfzhu1981@126.com+86 137 5209 0418

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026