Leukemia Clinical Trial
Official title:
Phase II Study in Adults With Untreated Acute Lymphoblastic Leukemia Testing Increased Doses of Daunorubicin During Induction, and Cytarabine During Consolidation, Followed by High-Dose Methotrexate and Intrathecal Methotrexate in Place of Cranial Irradiation
Verified date | July 2016 |
Source | Alliance for Clinical Trials in Oncology |
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 who have untreated acute lymphoblastic leukemia.
Status | Completed |
Enrollment | 163 |
Est. completion date | January 2010 |
Est. primary completion date | February 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years and older |
Eligibility |
1. Any other serious illnesses which would limit survival to <2 years, or psychiatric
condition which would prevent compliance with treatment or informed consent. 2. Uncontrolled or severe cardiovascular disease. 3. History of pancreatitis or overt coagulopathy (prior cerebrovascular accident or hemorrhage, transient ischemic attack or deep venous thrombosis). 4. Elevations in bilirubin, creatinine, or amylase that may suggest impaired hepatic, renal, or pancreatic function must be considered as potentially serious obstacles for safe tolerance of the therapy prescribed in this protocol. 5. Prior use of the agents administered in this protocol for other non-malignant disease may reduce the likelihood of beneficial outcome, and should also be considered prior to enrolling patients. 6. Treatment under this protocol would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective means of birth control. 7. Unequivocal histologic diagnosis of Acute Lymphoblastic leukemia (ALL), FAB L1-or L2 or Acute Undifferentiated Leukemia (AUL). 8. Age = 15 years 9. Prior Treatment: No prior treatment for leukemia, with three permissible exceptions: i. emergency leukapheresis; ii. emergency treatment for hyperleukocytosis with hydroxyurea; iii. cranial RT for CNS leukostasis (one dose only). |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland |
United States | Veterans Affairs Medical Center - Birmingham | Birmingham | Alabama |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Veterans Affairs Medical Center - Buffalo | Buffalo | New York |
United States | Vermont Cancer Center | Burlington | Vermont |
United States | Cooper Cancer Institute | Camden | New Jersey |
United States | Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | University of Chicago Cancer Research Center | Chicago | Illinois |
United States | University of Illinois at Chicago Health Sciences Center | Chicago | Illinois |
United States | Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago | Illinois |
United States | Ellis Fischel Cancer Center - Columbia | Columbia | Missouri |
United States | Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia | Missouri |
United States | Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio |
United States | Duke Comprehensive Cancer Center | Durham | North Carolina |
United States | Veterans Affairs Medical Center - Durham | Durham | North Carolina |
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
United States | University of California San Diego Cancer Center | La Jolla | California |
United States | CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada |
United States | Norris Cotton Cancer Center | Lebanon | New Hampshire |
United States | St. Barnabas Medical Center | Livingston | New Jersey |
United States | CCOP - North Shore University Hospital | Manhasset | New York |
United States | North Shore University Hospital | Manhasset | New York |
United States | University of Tennessee, Memphis Cancer Center | Memphis | Tennessee |
United States | Veterans Affairs Medical Center - Memphis | Memphis | Tennessee |
United States | CCOP - Mount Sinai Medical Center | Miami Beach | Florida |
United States | Veterans Affairs Medical Center - Minneapolis | Minneapolis | Minnesota |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | Mount Sinai Medical Center, NY | New York | New York |
United States | New York Presbyterian Hospital - Cornell Campus | New York | New York |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | St. Joseph's Hospital and Medical Center | Paterson | New Jersey |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | MBCCOP - Massey Cancer Center | Richmond | Virginia |
United States | Veterans Affairs Medical Center - Richmond | Richmond | Virginia |
United States | Barnes-Jewish Hospital | Saint Louis | Missouri |
United States | UCSF Cancer Center and Cancer Research Institute | San Francisco | California |
United States | Veterans Affairs Medical Center - San Francisco | San Francisco | California |
United States | CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse | New York |
United States | State University of New York - Upstate Medical University | Syracuse | New York |
United States | Veterans Affairs Medical Center - Syracuse | Syracuse | New York |
United States | Veterans Affairs Medical Center - Togus | Togus | Maine |
United States | Lombardi Cancer Center, Georgetown University | Washington | District of Columbia |
United States | Walter Reed Army Medical Center | Washington | District of Columbia |
United States | Veterans Affairs Medical Center - White River Junction | White River Junction | Vermont |
United States | CCOP - Christiana Care Health Services | Wilmington | Delaware |
United States | CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina |
United States | Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina |
United States | University of Massachusetts Memorial Medical Center | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States,
Stock W, Dodge RK, Vardiman JW, et al.: Treatment of adult acute lymphoblastic leukemia (ALL): phase II trial of dose intensification of Daunorubicin and Cytarabine followed by high-dose Methotrexate and intrathecal Methotrexate in place of cranial irradi
Stock W, Yu D, Johnson J, et al.: Intensified Daunorubicin during induction and post-remission therapy of adult acute lymphoblastic leukemia (ALL): results of CALGB 19802. [Abstract] Blood 102 (11 Pt 1): A-1375, 2003.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete Response | 6 months post treatment | No | |
Secondary | Toxicity | prior to ea tx and ea maintenance course | Yes | |
Secondary | CNS relapse rate | before ea tx, q 3 mon for 1 yr, q 6 mon for 2 yrs, then yrly up to 10 yrs | No |
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