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Trial record 8 of 18 for:    "Acute Promyelocytic Leukemia" | "Methotrexate"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00866918
Recruitment Status : Completed
First Posted : March 23, 2009
Results First Posted : April 4, 2017
Last Update Posted : September 17, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:
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 or disease Intervention/treatment 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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2009
Actual Primary Completion Date : June 2015


Arm Intervention/treatment
Experimental: Standard Risk (WBC < 10000/uL)
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

Active Comparator: High Risk (WBC > 10000/uL)
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




Primary Outcome Measures :
  1. Event-free Survival (EFS) [ Time Frame: At 3 years from study entry ]
    EFS - time from study entry until failure to achieve complete remission during consolidation, relapse, or death. For further clarification see definitions provided in the protocol.


Secondary Outcome Measures :
  1. Hematologic Remission Rate [ Time Frame: End of consolidation, course 1: up to 5 months ]
    Proportion of patients in hematologic remission at end of consolidation, course 1 are reported.

  2. Hematologic, Molecular, and Cytogenetic Remission Rate [ Time Frame: End of consolidation, course 3; up to 7 months (for Standard Risk) or end of consolidation, course 4; up to 9 months (for High Risk) ]
    Proportion of patients in hematologic, molecular, and cytogenetic remission at end of consolidation, course 3 and 4 are reported. Patients were determined to be in remission by all three criteria.

  3. Overall Survival (OS) [ Time Frame: At 3 years from study entry ]
    OS - time from study entry to death.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00866918


  Hide Study Locations
Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Children's Oncology Group
Arcadia, California, United States, 91006-3776
Southern California Permanente Medical Group
Downey, California, United States, 90242
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Miller Children's Hospital
Long Beach, California, United States, 90806
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
Children's Hospital Central California
Madera, California, United States, 93636-8762
Children's Hospital and Research Center at Oakland
Oakland, California, United States, 94609-1809
Childrens Hospital of Orange County
Orange, California, United States, 92868-3874
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States, 94304
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
University of California San Francisco Medical Center-Parnassus
San Francisco, California, United States, 94143
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
United States, Delaware
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
Lombardi Comprehensive Cancer Center at Georgetown University
Washington, District of Columbia, United States, 20057
United States, Florida
Lee Memorial Health System
Fort Myers, Florida, United States, 33901
Nemours Children's Clinic - Jacksonville
Jacksonville, Florida, United States, 32207-8426
Florida Hospital
Orlando, Florida, United States, 32803
Nemours Childrens Clinic - Orlando
Orlando, Florida, United States, 32806
UF Cancer Center at Orlando Health
Orlando, Florida, United States, 32806
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States, 32504
All Children's Hospital
Saint Petersburg, Florida, United States, 33701
Saint Joseph Children's Hospital of Tampa
Tampa, Florida, United States, 33607
Saint Mary's Hospital
West Palm Beach, Florida, United States, 33407
United States, Georgia
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, United States, 30322
Memorial Health University Medical Center
Savannah, Georgia, United States, 31403
United States, Hawaii
University of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60614
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, United States, 60453
Saint Jude Midwest Affiliate
Peoria, Illinois, United States, 61602
Southern Illinois University
Springfield, Illinois, United States, 62702
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Saint Vincent Hospital and Health Services
Indianapolis, Indiana, United States, 46260
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
United States, Michigan
C S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Wayne State University-Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
Michigan State University - Breslin Cancer Center
Lansing, Michigan, United States, 48910
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
The Childrens Mercy Hospital
Kansas City, Missouri, United States, 64108
Cardinal Glennon Children's Medical Center
Saint Louis, Missouri, United States, 63104
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nevada
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
UMDNJ - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
Saint Joseph's Regional Medical Center
Paterson, New Jersey, United States, 07503
Overlook Hospital
Summit, New Jersey, United States, 07902
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467-2490
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Columbia University Medical Center
New York, New York, United States, 10032
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Presbyterian Hospital
Charlotte, North Carolina, United States, 28204
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Sanford Medical Center-Fargo
Fargo, North Dakota, United States, 58122
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
The Children's Medical Center of Dayton
Dayton, Ohio, United States, 45404
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States, 43606
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, United States, 17033
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
Palmetto Health Richland
Columbia, South Carolina, United States, 29203
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States, 29605
Greenville Cancer Treatment Center
Greenville, South Carolina, United States, 29605
United States, Tennessee
T C Thompson Children's Hospital
Chattanooga, Tennessee, United States, 37403
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229
United States, Utah
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
United States, Wisconsin
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States, 53226
Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3J 3G9
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Centre Hospitalier Universitaire de Quebec
Ste-Foy, Quebec, Canada, G1V 4G2
Puerto Rico
San Jorge Children's Hospital
Santurce, Puerto Rico, 00912
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: John Gregory, MD Children's Oncology Group

Additional Information:
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00866918     History of Changes
Other Study ID Numbers: AAML0631
NCI-2011-01904 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000637184 ( Other Identifier: ClinicalTrials.gov )
AAML0631 ( Other Identifier: Children's Oncology Group )
AAML0631 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
First Posted: March 23, 2009    Key Record Dates
Results First Posted: April 4, 2017
Last Update Posted: September 17, 2019
Last Verified: February 2017
Additional relevant MeSH terms:
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Methotrexate
Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Cytarabine
Mercaptopurine
Mitoxantrone
Idarubicin
Arsenic Trioxide
Tretinoin
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antiviral Agents
Anti-Infective Agents