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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, Martín G, Verdeguer A, García P, Parody R, Fuster J, Molines A, Novo A, Debén G, Rodríguez 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

Page last updated: August 20, 2015

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