Cytarabine (Ara-C) in Children With Acute Promyelocytic Leukemia (APL)
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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. |
- 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 ]
- 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 |
Inclusion Criteria:
- Acute Promyelocytic Leukemia (APL)
Exclusion Criteria:
- > 16
Contacts and 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 | |
| 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 Leukemia, Promyelocytic, Acute Neoplasms by Histologic Type Neoplasms Leukemia, Myeloid, Acute Leukemia, Myeloid Cytarabine Tretinoin 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 Keratolytic Agents Dermatologic Agents |
ClinicalTrials.gov processed this record on May 22, 2013