Cytarabine (Ara-C) in Children With Acute Promyelocytic Leukemia (APL)
Information source: Chinese Academy of Medical Sciences
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia
Intervention: Ara-c (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Chinese Academy of Medical Sciences Official(s) and/or principal investigator(s): Xiaofan Zhu, MD, Principal Investigator, Affiliation: Department of Pediatrics, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Summary
Several groups, especially the PETHEMA group (in their LPA96 and 99 trials), obtained low
relapse rates in newly diagnosed Acute Promyelocytic Leukemia (APL) patients by combining
ll-transretinoic acid (ATRA) and anthracyclines without Ara-C, suggesting that avoiding
Ara-C in the chemotherapy of APL reduced treatment toxicity without increasing relapses.
While the relapse rate for the children with white blood cell(WBC) counts greater than
10×109/L at presentation were higher than those WBC counts less than 10×109/L (31% and
3. 5%,respectively) in the LPA96 and 99 trials. A recent adult randomized trial show that
avoiding Ara-C leads to an increased risk of relapse in the APL patients with WBC counts
less than 10Ă—109/L. The role of the Ara-C remains controversial. And there are very limited
data reported on children with APL so far.
Clinical Details
Official title: Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia in Children: Remission Induction With All-transretinoic Acid (ATRA) and Arsenic Trioxide (As2O3). Consolidation With Daunorubicin(DNR)+Ara-c or DNR Alone.
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To evaluate the impact of the addition of Ara-C to DNR courses of consolidation for patients on the disease-free survival
Secondary outcome: To evaluate the impact of the addition of Ara-C to DNR courses of consolidation for patients on the overall survival.To evaluate the impact of the addition of Ara-C to DNR courses of consolidation for patients on the event-free survival.
Detailed description:
Some studies suggest patients with high-risk disease should be treated with intensified
doses of anthracycline, or intermediate/ high-dose Ara-C or As2O3 as an early consolidation,
so as to decrease the risk of relapse. However, a higher cumulative dose of anthracycline may
lead to cardiac toxicity, especially for children. In addition, containing Ara-C will led to
more therapy-related toxicity. The benefit to add Ara-C to the schedules is questionable and
remains a matter of investigation in children.
Eligibility
Minimum age: 1 Year.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Acute Promyelocytic Leukemia (APL)
Exclusion Criteria:
- > 16
Locations and Contacts
Department of Pediatrics, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, PR China, Tianjin 300020, China; Recruiting Xiaofan Zhu, MD, Phone: +86 22 23909001, Email: zhuxiaof@yahoo.com.cn xiaofan Zhu, MD, Principal Investigator
Additional Information
Related publications: Ortega JJ, Madero L, MartĂn G, Verdeguer A, GarcĂa P, Parody R, Fuster J, Molines A, Novo A, DebĂ©n G, RodrĂguez A, Conde E, de la Serna J, Allegue MJ, Capote FJ, González JD, Bolufer P, González M, Sanz MA; PETHEMA Group. Treatment with all-trans retinoic acid and anthracycline monochemotherapy for children with acute promyelocytic leukemia: a multicenter study by the PETHEMA Group. J Clin Oncol. 2005 Oct 20;23(30):7632-40.
Starting date: May 2010
Last updated: August 30, 2010
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