Chemotherapy in Treating Children With Recurrent Acute Myeloid Leukemia

Leukemia Clinical Trial

Official title:

Idarubicin and Cladribine in Recurrent and Refractory Acute Myeloid Leukemia: A POG Phase II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003178
• Other study ID #: 9720
• Secondary ID: COG-P9720POG-972
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2000
• Last updated: July 24, 2014
• Start date: March 1998
• Est. completion date: March 2007

Study information

• Verified date: July 2014
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of idarubicin and cladribine in treating children who have recurrent acute myeloid leukemia.

Description:

OBJECTIVES:

• Determine the complete response rate in children with primary refractory or recurrent acute myeloid leukemia (AML) or secondary AML treated with idarubicin and cladribine. (Refractory AML stratum closed as of 4/3/01) (Secondary AML stratum closed as of 04/02/02)

• Compare the remission reinduction rates in children who relapse at 1 year or earlier vs more than 1 year from time of initial remission.

• Determine the toxic effects of this regimen in this patient population.

OUTLINE: Patients are stratified according to disease characteristics (primary or secondary acute myeloid leukemia (AML) with first untreated relapse vs primary refractory AML). (Refractory AML stratum closed as of 4/3/01) (Secondary AML stratum closed as of 04/02/02)

Patients receive idarubicin IV over 15 minutes on days 1-3, cladribine IV over 2 hours on days 1-5, and filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing until blood counts have recovered for 2 days. Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response after completion of course 1 may proceed to other chemotherapy or bone marrow transplantation at the discretion of the protocol investigator. Patients with extramedullary disease may receive intrathecal chemotherapy or radiotherapy to symptomatic sites.

Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 51-102 patients will be accrued for this study within 3 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2007
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

DISEASE CHARACTERISTICS:

• One of the following diagnoses:

• Acute myeloid leukemia (AML) (FAB M0-M7)

• Secondary AML in first relapse (Secondary AML stratum closed as of 04/02/02)

• AML in primary induction failure (Refractory AML stratum closed as of 04/03/01)

• Myelodysplastic syndromes (MDS) (not related to Down syndrome) (MDS stratum closed as of 04/03/01)

• Extramedullary disease allowed

• Relapse more than 6 months after allogeneic or autologous bone marrow transplantation allowed

PATIENT CHARACTERISTICS:

Age:

• Under 21 at diagnosis

Performance status:

• Karnofsky 50-100% (over 10 years)

• Lansky 50-100% (10 years and under)

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin less than 1.5 mg/dL

• ALT less than 3 times normal

Renal:

• Creatinine less than 2 times normal

Cardiovascular:

• Shortening fraction greater than 29%

• Ejection fraction greater than 55% with normal wall motion

Other:

• No uncontrolled infection

• Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

Chemotherapy:

• At least 12 weeks since prior idarubicin and recovered

• At least 2 weeks since other prior chemotherapy and recovered

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Biological:
• filgrastim

Drug:
• cladribine

• idarubicin

Locations

Country	Name	City	State
Australia	Royal Children's Hospital	Brisbane	Queensland
Australia	Women's and Children's Hospital	North Adelaide	South Australia
Australia	Royal Children's Hospital	Parkville	Victoria
Australia	Princess Margaret Hospital for Children	Perth	Western Australia
Australia	Sydney Children's Hospital	Randwick	New South Wales
Australia	Children's Hospital at Westmead	Westmead	New South Wales
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	Children's Hospital	Hamilton	Ontario
Canada	Children's Hospital of Western Ontario	London	Ontario
Canada	Hopital Sainte Justine	Montreal	Quebec
Canada	McGill University Health Center - Montreal Children's Hospital	Montreal	Quebec
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	Centre Hospitalier de L'Universite Laval	Sainte Foy	Quebec
Canada	Laval University Medical Center	Sainte-Foy	Quebec
Canada	Saskatoon Cancer Centre	Saskatoon	Saskatchewan
Canada	Janeway Children's Health and Rehabilitation Centre	St. John's	Newfoundland and Labrador
Canada	Hospital for Sick Children	Toronto	Ontario
Canada	British Columbia Children's Hospital	Vancouver	British Columbia
Canada	CancerCare Manitoba	Winnipeg	Manitoba
Netherlands	Academisch Ziekenhuis Groningen	Groningen
New Zealand	Starship Children's Hospital	Auckland
Puerto Rico	University of Puerto Rico School of Medicine Medical Sciences Campus	San Juan
Puerto Rico	San Jorge Childrens Hospital	Santurce
Switzerland	Swiss Pediatric Oncology Group Bern	Bern
Switzerland	Swiss Pediatric Oncology Group Geneva	Geneva
Switzerland	Swiss Pediatric Oncology Group Lausanne	Lausanne
United States	Children's Hospital Medical Center of Akron	Akron	Ohio
United States	Cancer Center of Albany Medical Center	Albany	New York
United States	University of New Mexico Cancer Research and Treatment Center	Albuquerque	New Mexico
United States	Texas Tech University Health Sciences Center School of Medicine	Amarillo	Texas
United States	Mott Children's Hospital	Ann Arbor	Michigan
United States	Mission Saint Joseph's Health System	Asheville	North Carolina
United States	Children's Healthcare of Atlanta - Scottish Rite	Atlanta	Georgia
United States	Emory University Hospital - Atlanta	Atlanta	Georgia
United States	Medical College of Georgia Comprehensive Cancer Center	Augusta	Georgia
United States	Children's Hospital of Austin	Austin	Texas
United States	Marlene and Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Eastern Maine Medical Center	Bangor	Maine
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Mountain States Tumor Institute	Boise	Idaho
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Floating Hospital for Children	Boston	Massachusetts
United States	Albert Einstein Clinical Cancer Center	Bronx	New York
United States	Brookdale University Hospital and Medical Center	Brooklyn	New York
United States	Brooklyn Hospital Center	Brooklyn	New York
United States	Maimonides Medical Center	Brooklyn	New York
United States	State University of New York Health Science Center at Brooklyn College of Medicine	Brooklyn	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Vermont Cancer Center	Burlington	Vermont
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	West Virginia University - Charleston	Charleston	West Virginia
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Presbyterian Healthcare	Charlotte	North Carolina
United States	Cancer Center at the University of Virginia	Charlottesville	Virginia
United States	Children's Memorial Hospital - Chicago	Chicago	Illinois
United States	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Children's Hospital Medical Center - Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Palmetto Health South Carolina Cancer Center	Columbia	South Carolina
United States	Children's Hospital of Columbus	Columbus	Ohio
United States	Medical City Dallas Hospital	Dallas	Texas
United States	Simmons Cancer Center - Dallas	Dallas	Texas
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Children's Medical Center - Dayton	Dayton	Ohio
United States	Childhood Hematology/Oncology Associates	Denver	Colorado
United States	Children's Hospital of Denver	Denver	Colorado
United States	Presbyterian-St Luke's Medical Center	Denver	Colorado
United States	John Stoddard Cancer Center	Des Moines	Iowa
United States	Raymond Blank Memorial Hospital for Children	Des Moines	Iowa
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	Henry Ford Hospital	Detroit	Michigan
United States	St. John Hospital and Medical Center	Detroit	Michigan
United States	Southern California Permanente Medical Group	Downey	California
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	St. Mary's/Duluth Clinic Cancer Center	Duluth	Minnesota
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Michigan State University	East Lansing	Michigan
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Dakota Cancer Institute	Fargo	North Dakota
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	Hurley Medical Center	Flint	Michigan
United States	Broward General Medical Center	Fort Lauderdale	Florida
United States	Children's Hospital of Southwest Florida	Fort Myers	Florida
United States	Cook Children's Medical Center - Fort Worth	Fort Worth	Texas
United States	Shands Hospital and Clinics, University of Florida	Gainesville	Florida
United States	University of Texas Medical Branch	Galveston	Texas
United States	Spectrum Health and DeVos Children's Hospital	Grand Rapids	Michigan
United States	Bellin Memorial Hospital	Green Bay	Wisconsin
United States	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin
United States	St. Vincent Hospital	Green Bay	Wisconsin
United States	Children's Hospital of Greenville Hospital System	Greenville	South Carolina
United States	East Carolina University School of Medicine	Greenville	North Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Joe DiMaggio Children's Hospital at Memorial	Hollywood	Florida
United States	Cancer Research Center of Hawaii	Honolulu	Hawaii
United States	MBCCOP - Hawaii	Honolulu	Hawaii
United States	Tripler Army Medical Center	Honolulu	Hawaii
United States	Baylor College of Medicine	Houston	Texas
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Cabell-Huntington Hospital, Inc	Huntington	West Virginia
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	St. Vincent Hospital and Health Care Center	Indianapolis	Indiana
United States	Holden Comprehensive Cancer Center	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Nemours Children's Clinic	Jacksonville	Florida
United States	East Tennessee State University Cancer Center at JCMC	Johnson City	Tennessee
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	East Tennessee Children's Hospital	Knoxville	Tennessee
United States	Gundersen Lutheran Medical Center	La Crosse	Wisconsin
United States	Rebecca and John Moores UCSD Cancer Center	La Jolla	California
United States	San Antonio Military Pediatric Cancer and Blood Disorders Center	Lackland Air Force Base	Texas
United States	Sunrise Hospital and Medical Center	Las Vegas	Nevada
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Loma Linda University Medical Center	Loma Linda	California
United States	Jonathan Jaques Children's Cancer Center	Long Beach	California
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	Kosair Children's Hospital	Louisville	Kentucky
United States	Covenant Children's Hospital	Lubbock	Texas
United States	Medical Center of Central Georgia	Macon	Georgia
United States	Children's Hospital Central California	Madera	California
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	North Shore University Hospital	Manhasset	New York
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	Saint Jude Children's Research Hospital	Memphis	Tennessee
United States	Baptist Hospital of Miami	Miami	Florida
United States	Miami Children's Hospital	Miami	Florida
United States	University of Miami-Jackson Memorial Hospital	Miami	Florida
United States	Midwest Children's Cancer Center	Milwaukee	Wisconsin
United States	Children's Hospitals and Clinics - Minneapolis	Minneapolis	Minnesota
United States	University of South Alabama Medical Center	Mobile	Alabama
United States	West Virginia University Hospitals	Morgantown	West Virginia
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Yale Comprehensive Cancer Center	New Haven	Connecticut
United States	Schneider Children's Hospital	New Hyde Park	New York
United States	Children's Hospital of New Orleans	New Orleans	Louisiana
United States	Ochsner Clinic	New Orleans	Louisiana
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	Columbia Presbyterian Hospital	New York	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	New York Presbyterian Hospital - Cornell Campus	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Children's Hospital of the King's Daughters	Norfolk	Virginia
United States	Hope Children's Hospital	Oak Lawn	Illinois
United States	Children's Hospital of Oakland	Oakland	California
United States	Children's Hospital of Oklahoma	Oklahoma City	Oklahoma
United States	Children's Hospital of Omaha	Omaha	Nebraska
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Chao Family Comprehensive Cancer Center	Orange	California
United States	Children's Hospital of Orange County	Orange	California
United States	Florida Hospital Cancer Institute	Orlando	Florida
United States	Nemours Children's Clinic-Orlando	Orlando	Florida
United States	Lucile Packard Children's Hospital at Stanford	Palo Alto	California
United States	Lutheran General Hospital	Park Ridge	Illinois
United States	St. Joseph's Hospital and Medical Center	Paterson	New Jersey
United States	Sacred Heart Children's Hospital	Pensacola	Florida
United States	Saint Jude Midwest Affiliate	Peoria	Illinois
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	St. Christopher's Hospital for Children	Philadelphia	Pennsylvania
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Doernbecher Children's Hospital	Portland	Oregon
United States	Legacy Emanuel Hospital and Health Center	Portland	Oregon
United States	Naval Medical Center, Portsmouth	Portsmouth	Virginia
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Massey Cancer Center	Richmond	Virginia
United States	Carilion Medical Center for Children	Roanoke	Virginia
United States	James P. Wilmot Cancer Center	Rochester	New York
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	CCOP - Beaumont	Royal Oak	Michigan
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Sutter Cancer Center	Sacramento	California
United States	University of California Davis Medical Center	Sacramento	California
United States	Cardinal Glennon Children's Hospital	Saint Louis	Missouri
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	Children's Hospitals and Clinics of Minnesota	Saint Paul	Minnesota
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Methodist Health Care System	San Antonio	Texas
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Children's Hospital San Diego	San Diego	California
United States	Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego	San Diego	California
United States	Kaiser Permanente Medical Center - San Francisco Geary Campus	San Francisco	California
United States	UCSF Comprehensive Cancer Center	San Francisco	California
United States	Santa Barbara Cottage Hospital	Santa Barbara	California
United States	Kaiser Permanente Medical Center - Santa Clara	Santa Clara	California
United States	Memorial Health University Medical Center, Inc.	Savannah	Georgia
United States	Maine Children's Cancer Program	Scarborough	Maine
United States	Children's Hospital and Regional Medical Center - Seattle	Seattle	Washington
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Group Health Cooperative	Seattle	Washington
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Sioux Valley Hospital	Sioux Falls	South Dakota
United States	Deaconess Medical Center	Spokane	Washington
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	All Children's Hospital	St. Petersburg	Florida
United States	State University of New York Health Sciences Center - Stony Brook	Stony Brook	New York
United States	Atlantic Health System	Summit	New Jersey
United States	State University of New York - Upstate Medical University	Syracuse	New York
United States	Madigan Army Medical Center	Tacoma	Washington
United States	Mary Bridge Children's Health Center	Tacoma	Washington
United States	Tampa Children's Hospital	Tampa	Florida
United States	Scott and White Memorial Hospital	Temple	Texas
United States	St. Vincent Mercy Medical Center	Toledo	Ohio
United States	Toledo Children's Hospital	Toledo	Ohio
United States	David Grant Medical Center	Travis Air Force Base	California
United States	Arizona Cancer Center	Tucson	Arizona
United States	CCOP - Oklahoma	Tulsa	Oklahoma
United States	Natalie Warren Bryant Cancer Center	Tulsa	Oklahoma
United States	New York Medical College	Valhalla	New York
United States	Children's National Medical Center	Washington	District of Columbia
United States	Lombardi Cancer Center	Washington	District of Columbia
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	St. Mary's Hospital	West Palm Beach	Florida
United States	Wesley Medical Center	Wichita	Kansas
United States	Alfred I. Dupont Institute	Wilmington	Delaware
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina
United States	University of Massachusetts Memorial Medical Center - University Campus	Worcester	Massachusetts
United States	Forum Health-Tod Childrens Hospital	Youngstown	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Netherlands,  New Zealand,  Puerto Rico,  Switzerland, 

References & Publications (1)

Chaleff S, Hurwitz CA, Chang M, Dahl G, Alonzo TA, Weinstein H. Phase II study of 2-chlorodeoxyadenosine plus idarubicin for children with acute myeloid leukaemia in first relapse: a paediatric oncology group study. Br J Haematol. 2012 Mar;156(5):649-55. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event Free Survival	EFS will be estimated by Kaplan-Meier31 method. Prognostic factor analyses will be performed descriptively due to the limited sample size.		No