Leukemia Clinical Trial
Official title:
Acute Myeloid Leukemia Salvage Therapy for Patients in First Relapse or Who Fail to Achieve an Initial Remission or Who Develop AML as a Second Malignant Neoplasm
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 |
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 combination chemotherapy in treating
patients with acute myeloid leukemia or myelodysplastic syndrome in first relapse or who did
not achieve first remission.
Status | Completed |
Enrollment | 115 |
Est. completion date | June 2008 |
Est. primary completion date | May 2001 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 21 Years |
Eligibility |
DISEASE CHARACTERISTICS: Acute myeloid leukemia (AML) or myelodysplastic syndrome in one
of the following categories: In first relapse Failed to achieve initial complete remission
Newly diagnosed secondary AML eligible Required bone marrow status: Greater than 25%
blasts (M3) OR Persistent abnormal clone on cytogenetics and 5-25% blasts (M2) No
Fanconi's anemia PATIENT CHARACTERISTICS: Age: Under 22 Performance status: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 1.5 times normal AST or ALT less than 4.0 times normal Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance or GFR greater than 70 mL/min per 1.73 square meters or GFR in equivalent institutional normal range Cardiovascular: Shortening fraction greater than 27% by echocardiogram or in institutional normal range OR Ejection fraction greater than 47% by radionuclide angiogram PRIOR CONCURRENT THERAPY: No more than 1 prior treatment No prior salvage therapy No prior mitoxantrone |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Princess Margaret Hospital for Children | Perth | Western Australia |
Canada | IWK Grace Health Centre | Halifax | Nova Scotia |
Canada | British Columbia Children's Hospital | Vancouver | British Columbia |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina |
United States | University of Chicago Cancer Research Center | Chicago | Illinois |
United States | Children's Hospital Medical Center - Cincinnati | Cincinnati | Ohio |
United States | Ireland Cancer Center | Cleveland | Ohio |
United States | Children's Hospital of Columbus | Columbus | Ohio |
United States | Children's Hospital of Denver | Denver | Colorado |
United States | CCOP - Merit Care Hospital | Fargo | North Dakota |
United States | Veterans Affairs Medical Center - Fargo | Fargo | North Dakota |
United States | University of Texas - MD Anderson Cancer Center | Houston | Texas |
United States | Indiana University Cancer Center | Indianapolis | Indiana |
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
United States | CCOP - Kalamazoo | Kalamazoo | Michigan |
United States | Children's Mercy Hospital - Kansas City | Kansas City | Missouri |
United States | Long Beach Memorial Medical Center | Long Beach | California |
United States | Children's Hospital Los Angeles | Los Angeles | California |
United States | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California |
United States | University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin |
United States | University of Minnesota Cancer Center | Minneapolis | Minnesota |
United States | Vanderbilt Cancer Center | Nashville | Tennessee |
United States | Cancer Institute of New Jersey | New Brunswick | New Jersey |
United States | Herbert Irving Comprehensive Cancer Center | New York | New York |
United States | Kaplan Cancer Center | New York | New York |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Children's Hospital of Orange County | Orange | California |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Doernbecher Children's Hospital | Portland | Oregon |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Huntsman Cancer Institute | Salt Lake City | Utah |
United States | UCSF Cancer Center and Cancer Research Institute | San Francisco | California |
United States | Children's Hospital and Medical Center - Seattle | Seattle | Washington |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
United States | Children's National Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | National Cancer Institute (NCI) |
United States, Australia, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Estimate second remission rate and survival rate | 3 years | No | |
Secondary | Evaluate the mortality of the start of VP-16/Ara-C intensification | 45 days | No | |
Secondary | Compare outcomes by the ethnicity and gender | Compare outcomes by the ethnicity (and gender) in study CCG-2951, and will control for ethnicity in multivariate models comparing the treatment arms | No |
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