Cytarabine (Ara-C) in Children With Acute Promyelocytic Leukemia (APL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2010 by Chinese Academy of Medical Sciences
Sponsor:
Information provided by:
Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01191541
First received: August 18, 2010
Last updated: August 30, 2010
Last verified: August 2010
  Purpose

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 10×109/L. The role of the Ara-C remains controversial. And there are very limited data reported on children with APL so far.


Condition Intervention
Leukemia
Drug: Ara-c

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • To evaluate the impact of the addition of Ara-C to DNR courses of consolidation for patients on the disease-free survival [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the impact of the addition of Ara-C to DNR courses of consolidation for patients on the overall survival. [ Time Frame: two years ] [ Designated as safety issue: No ]
  • To evaluate the impact of the addition of Ara-C to DNR courses of consolidation for patients on the event-free survival. [ Time Frame: two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
DNR+Ara-c,DNR
one group treated with DNR+Ara-C one group treated with DNR
Drug: Ara-c

Drug: ATRA 25mg/m2 day until complete remission (CR)

Drug: As2O3 Induction:0.15-0.2mg/kg d1-28 iv Consolidation: 0.15-0.2mg/kg d1-28 iv in cycle 2 Drug: Idarubicin 10 mg/m2 days1-3 in Consolidation1 Drug: Ara-C some patients consolidation with Ara-C in cycles 3 and 4. Ara-c 1g/m2 d1-3 iv Drug: DNR 45 mg/m2 days1-3 in Consolidation 3 and 4

Other Name: Cytarabine: Pfizer Pharmaceuticals Limited

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

Ages Eligible for Study:   1 Year to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute Promyelocytic Leukemia (APL)

Exclusion Criteria:

  • > 16
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191541

Locations
China
Department of Pediatrics, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, PR China Recruiting
Tianjin, China, 300020
Contact: Xiaofan Zhu, MD    +86 22 23909001    zhuxiaof@yahoo.com.cn   
Principal Investigator: xiaofan Zhu, MD         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
Principal Investigator: Xiaofan Zhu, MD Department of Pediatrics, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  More Information

Publications:
Responsible Party: Department of pedistric, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 288 Nanjing Road, Tianjin 300020 (PR China), Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
ClinicalTrials.gov Identifier: NCT01191541     History of Changes
Other Study ID Numbers: CCAPL2010
Study First Received: August 18, 2010
Last Updated: August 30, 2010
Health Authority: China: Ministry of Health

Keywords provided by Chinese Academy of Medical Sciences:
ara-c
As2O3
pediatric
acute

Additional relevant MeSH terms:
Leukemia, Promyelocytic, Acute
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014