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

This study has suspended participant recruitment.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00866918
First received: March 20, 2009
Last updated: November 7, 2012
Last verified: November 2012
  Purpose

RATIONALE: 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.

PURPOSE: This phase III trial is studying combination chemotherapy to see how well it works in treating young patients with newly diagnosed acute promyelocytic leukemia.


Condition Intervention Phase
Leukemia
Drug: arsenic trioxide
Drug: cytarabine
Drug: idarubicin
Drug: mercaptopurine
Drug: methotrexate
Drug: mitoxantrone hydrochloride
Drug: tretinoin
Genetic: cytogenetic analysis
Genetic: polymerase chain reaction
Other: laboratory biomarker analysis
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Risk Adapted Treatment of Newly Diagnosed Childhood Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide (Trisenox® IND #103331) During Consolidation

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Event-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hematologic, molecular, and cytogenetic remission rates after each phase of therapy [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Percentage of patients experiencing grade 3 or 4 toxicity, or cardiac toxicity of any grade [ Designated as safety issue: Yes ]
  • Time to blood count recovery [ Designated as safety issue: No ]
  • Duration of hospitalization [ Designated as safety issue: No ]

Estimated Enrollment: 132
Study Start Date: March 2009
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

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

DISEASE CHARACTERISTICS:

  • New clinically and morphologically confirmed diagnosis of acute promyelocytic leukemia (APL) (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
  • If the real-time quantitative (RQ)-PCR results are known, the patient must demonstrate PML-RARA and/or RARA-PML transcripts by RQ-PCR
  • 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)

PATIENT CHARACTERISTICS:

  • No minimal performance status criteria
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No pre-existing prolonged QT syndrome

PRIOR CONCURRENT THERAPY:

  • Prior intrathecal cytarabine prior to the diagnosis of acute promyelocytic leukemia (APL) allowed
  • Prior corticosteroids, hydroxyurea, and leukapheresis allowed
  • No prior systemic definitive treatment for APL or other suspected leukemia, including cytotoxic chemotherapy, retinoids, or arsenic
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00866918

  Hide Study Locations
Locations
United States, Alabama
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016-7710
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, California, United States, 90801
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
Southern California Permanente Medical Group
Los Angeles, California, United States, 90027
Children's Hospital Central California
Madera, California, United States, 93638-8762
Children's Hospital and Research Center Oakland
Oakland, California, United States, 94609
Children's Hospital of Orange County
Orange, California, United States, 92868
Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto, California, United States, 95798
Sutter Cancer Center
Sacramento, California, United States, 95816
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123-4282
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Colorado
Children's Hospital Colorado Center for Cancer and Blood Disorders
Aurora, Colorado, United States, 80045
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
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, 20010-2970
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Florida
Lee Cancer Care of Lee Memorial Health System
Fort Myers, Florida, United States, 33901
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States, 32803-1273
M.D. Anderson Cancer Center at Orlando
Orlando, Florida, United States, 32806
Nemours Children's Clinic - Orlando
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
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, United States, 33607
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach, Florida, United States, 33407
United States, Georgia
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
Atlanta, Georgia, United States, 30322
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States, 60611
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Keyser Family Cancer Center at Advocate Hope Children's Hospital
Oak Lawn, Illinois, United States, 60453
Saint Jude Midwest Affiliate
Peoria, Illinois, United States, 61603
Simmons Cooper Cancer Institute
Springfield, Illinois, United States, 62794-9677
United States, Indiana
Riley's Children Cancer Center at Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States, 40536-0093
Kosair Children's Hospital
Louisville, Kentucky, United States, 40232
United States, Louisiana
Tulane Cancer Center Office of Clinical Research
Alexandria, Louisiana, United States, 71315-3198
United States, Maine
CancerCare of Maine at Eastern Maine Medical Center
Bangor, Maine, United States, 04401
United States, Maryland
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States, 21215
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 2115
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield, Massachusetts, United States, 01199-0001
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Michigan
C.S. Mott Children's Hospital at University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109-0286
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, United States, 48910
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Cardinal Glennon Children's Hospital
St. Louis, Missouri, United States, 63104
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St. Louis, Missouri, United States, 63110
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89109-2306
United States, New Jersey
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States, 07601
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States, 07503
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Summit, New Jersey, United States, 07901
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States, 10032
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
United States, North Carolina
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
Duke Cancer Institute
Durham, North Carolina, United States, 27710
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, North Dakota
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44308-1062
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106-5000
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205-2696
Dayton Children's - Dayton
Dayton, Ohio, United States, 45404-1815
Toledo Hospital
Toledo, Ohio, United States, 43606
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
Penn State Children's Hospital
Hershey, Pennsylvania, United States, 17033-0850
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Palmetto Health South Carolina Cancer Center
Columbia, South Carolina, United States, 29203
BI-LO Charities Children's Cancer 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
Fort Worth, Texas, United States, 76104
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229-3993
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78207
United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113-1100
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105
United States, Wisconsin
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Midwest Children's Cancer Center at Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, British Columbia
Children's and Women's Hospital of British Columbia
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
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Canada
Centre Hospitalier Universitaire de Quebec
Quebec, Canada, G1V 4G2
Puerto Rico
San Jorge Children's Hospital
Santurce, Puerto Rico, 00912
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: John J. Gregory, MD Goryeb Children's Hospital at Morristown Memorial Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Gregory H. Reaman, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT00866918     History of Changes
Other Study ID Numbers: CDR0000637184, COG-AAML0631
Study First Received: March 20, 2009
Last Updated: November 7, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood acute promyelocytic leukemia (M3)

Additional relevant MeSH terms:
Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid
6-Mercaptopurine
Cytarabine
Methotrexate
Arsenic trioxide
Idarubicin
Mitoxantrone
Tretinoin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Antiviral Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 23, 2013