NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000000645

Registered date:19/03/2007

Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-P05: A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Promyelocytic Leukemia (APL)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedAcute promyelocytic leukemia
Date of first enrollment2006/04/01
Target sample size44
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Five courses of multi-agent combination chemotherapy (2 courses for remission induction and 3 for intensification) consisted of ATRA, anthracyclines, and cytarabine, followed by single-agent maintenance chemotherapy of ATRA for all the eligible patients.

Outcome(s)

Primary OutcomeThree-year event-free survival rate
Secondary OutcomeRemission induction rate Three-year overall survival rate Rate of adverse events Rate of DIC or retinoic acid syndrome in the first remission induction therapy Rate of mortality in the first remission induction therapy Three-year CNS relapse rate

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximum18years-old
GenderMale and Female
Include criteriaPatient with a diagnosis of APL Genetically or cytogenetically diagnosed by either one of three examination; chromosome, FISH, or southern blot Age less than 18 years old ECOG performance status score of 0-2, or of 3 when caused by leukemia No previous treatment Sufficient hepatic, renal, and cardiac function Possible clinical observation for more than 3 years Written informed consent obtained from guardians
Exclude criteriaCNS hemorrhage which is likely to interfere protocol therapy Secondary APL due to previous chemotherapy or radiation therapy Unmanageable infectious disease including tuberculosis Pregnancy Septic shock History of organ transplantation History of congenital or acquired immunodeficiency Any inappropriate status judged by physician

Related Information

Contact

public contact
Name Tetsuya Takimoto
Address National Nagoya Hospital, 4-1-1, San-nomaru, Naka-ku, Nagoya Japan
Telephone 052(951)1111
E-mail jplsgdata@nnh.hosp.go.jp
Affiliation JPLSG Deta Center
scientific contact
Name Hiroyuki Takahashi
Address 6-11-1 Omorinishi, Ota-ku, Tokyo 143-8451 Japan
Telephone 03(3762)4151
E-mail taccn@fb3.so-net.ne.jp
Affiliation Toho University Department of Pediatrics