Trial record 15 of 136 for:    "acute promyelocytic leukemia"

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Children's Oncology Group Identifier:
First received: March 20, 2009
Last updated: March 3, 2015
Last verified: March 2015

This phase III trial is studying combination chemotherapy to see how well it works in treating young patients with newly diagnosed acute promyelocytic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

Condition Intervention Phase
Childhood Acute Promyelocytic Leukemia (M3)
Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
Drug: arsenic trioxide
Drug: mitoxantrone hydrochloride
Other: diagnostic laboratory biomarker analysis
Drug: idarubicin
Drug: tretinoin
Drug: cytarabine
Drug: mercaptopurine tablet
Drug: methotrexate
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Risk Adapted Treatment of Newly Diagnosed Childhood Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide (Trisenox® IND# 103, 331) During Consolidation

Resource links provided by NLM:

Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Event-free survival [ Time Frame: Time from on study to failure to achieve hematological CR after Consolidation 1, relapse, or death, assessed up to 10 years ] [ Designated as safety issue: No ]
    The Kaplan-Meier method will be used to estimate the EFS of children enrolled on AAML0631 and the EFS of children enrolled on C9710 who were between the ages of 2 and 21 at the time of diagnosis and did not receive arsenic. A test of the difference in EFS will be performed using the log-rank test. Log-rank tests will be used to compare overall survival (OS) and EFS for those with and without FLT3 mutations.

Secondary Outcome Measures:
  • Hematologic, molecular, and cytogenetic remission rates after each phase of therapy [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Kaplan-Meier curves will be used to estimate OS for those with and without FLT3 mutations separately for each risk group. Log-rank tests will be used to compare OS and EFS for those with and without FLT3 mutations.

  • Percentage of patients experiencing grade 3 or 4 toxicity, or cardiac toxicity of any grade [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
    Will utilize the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) for toxicity and performance reporting.

  • Time to blood count recovery [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Duration of hospitalization [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Enrollment: 108
Study Start Date: March 2009
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (combination chemotherapy)
See Detailed Description
Drug: arsenic trioxide
Given IV
Other Names:
  • Arsenic (III) Oxide
  • Arsenic Sesquioxide
  • Arsenous Acid Anhydride
  • AS2O3
  • Trisenox
Drug: mitoxantrone hydrochloride
Given IV
Other Names:
  • CL 232315
  • DHAD
  • DHAQ
  • Novantrone
Other: diagnostic laboratory biomarker analysis
Correlative studies
Drug: idarubicin
Given IV
Other Names:
  • 4-demethoxydaunorubicin
  • 4-DMDR
  • DMDR
  • IDA
Drug: tretinoin
Given orally
Other Names:
  • ATRA
  • Retin-A
  • TRA
Drug: cytarabine
Given IT or IV
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: mercaptopurine tablet
Given orally
Other Names:
  • 6-mercaptopurine
  • 6-MP
  • Leukerin
  • MP
Drug: methotrexate
Given orally
Other Names:
  • amethopterin
  • Folex
  • methylaminopterin
  • Mexate
  • MTX

  Show Detailed Description


Ages Eligible for Study:   2 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must be newly diagnosed with a clinical diagnosis of acute promyelocytic leukemia initially by morphology (bone marrow or peripheral blood); bone marrow is highly preferred but in cases where marrow cannot be obtained at diagnosis, peripheral blood will be accepted; APL is considered a hematological emergency and treatment should be initiated as quickly as possible without waiting for molecular or cytogenetic/fluorescence in situ hybridization (FISH) confirmation; for patients who are unable to begin receiving ATRA in a timely manner following a presumed diagnosis of APL, consideration should be given to initiating ATRA and proceeding with treatment outside of the AAML0631 protocol; if the RQ-PCR results are known at the time of study enrollment, the patient must demonstrate PML-RARA and/or RARA-PML transcripts by RQ-PCR to be eligible; patients without evidence of APL by bone marrow or peripheral blood morphology but with isolated myeloid sarcoma (myeloblastoma; chloroma, including leukemia cutis) are eligible provided that the t(15;17) translocation is documented on either marrow or tumor tissue by cytogenetics, FISH, or PCR prior to study enrollment; in this situation, touch preps from the tumor site can be evaluated by FISH with PML-RARA probes; NOTE: A lumbar puncture is not required to be enrolled on study; if the diagnosis of APL is known or suspected, extreme caution must be exercised in performing a lumbar puncture during active coagulopathy; in addition a computed tomography (CT) or magnetic resonance imaging (MRI) should be considered to rule out the possibility of an associated chloroma if central nervous system (CNS) disease is suspected or proven; if CNS disease is documented, patients are still eligible
  • No minimal performance status criteria
  • The patient must not have received systemic definitive treatment for APL or other suspected leukemia, including cytotoxic chemotherapy, retinoids, or arsenic; prior therapy with corticosteroids, hydroxyurea, or leukopheresis will not exclude the patient; if a patient received intrathecal cytarabine prior to the diagnosis of APL being known, the patient will still be eligible as long as they meet all other eligibility requirements

Exclusion Criteria:

  • Pregnant women or nursing mothers are excluded; treatment under this protocol would expose an unborn child to significant risks; patients should not be pregnant or plan to become pregnant while on treatment; women and men of reproductive potential should agree to use an effective means of birth control; there is an extremely high risk of fetal malformation if pregnancy occurs while on ATRA in any amount even for short periods
  • Patients with a pre-existing prolonged QT Syndrome will not be eligible for this protocol due to the use of arsenic trioxide which can prolong the QT interval
  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 identifier: NCT00866918

  Show 111 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Principal Investigator: John Gregory, MD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group Identifier: NCT00866918     History of Changes
Other Study ID Numbers: AAML0631, NCI-2011-01904, CDR0000637184, AAML0631, AAML0631, U10CA098543
Study First Received: March 20, 2009
Last Updated: March 3, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Promyelocytic, Acute
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Arsenic trioxide
Antimetabolites, Antineoplastic
Antineoplastic Agents
Central Nervous System Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors processed this record on March 26, 2015