⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Comparison of Three Treatment Regimens in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Comparison of Three Treatment Regimens in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia

Official Title: A Phase II Randomized Trial of Immunologic and Chemotherapeutic Agents for Treatment of Patients With Relapsed or Refractory Acute Myelogenous Leukemia

Study ID: NCT00005962

Conditions

Leukemia

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining more than one drug or combining monoclonal antibody with chemotherapy may kill more cancer cells. It is not yet known which treatment regimen is more effective for acute myelogenous leukemia. PURPOSE: Randomized phase II trial to compare the effectiveness of three treatment regimens in treating patients who have relapsed or refractory acute myelogenous leukemia.

Detailed Description: OBJECTIVES: * Compare the rates of complete response (CR) and CR without full platelet recovery in patients with relapsed or refractory acute myelogenous leukemia treated with gemtuzumab ozogamicin and cytarabine vs daunorubicin liposomal and cytarabine vs cyclophosphamide, cytarabine, and topotecan. * Compare the toxicities of these 3 regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified by disease status (relapse less than 6 months after first complete response (CR) vs relapse 6-12 months after first CR vs refractory to conventional initial induction chemotherapy (no more than 2 courses) or first reinduction (no more than 1 course) vs second or greater relapse). * Induction: Patients are randomized to 1 of 3 treatment arms: * Arm I: Patients receive cytarabine IV over 2 hours on days 1-4 and gemtuzumab ozogamicin IV over 2 hours on day 5. * Arm II: Patients receive daunorubicin liposomal IV over a minimum of 2 hours on days 1-3 and cytarabine IV over 2 hours (beginning immediately after completion of daunorubicin liposomal infusion) on days 1-4. * Arm III: Patients receive cyclophosphamide IV over 1 hour every 12 hours on days 1-3, cytarabine IV over 2 hours (beginning immediately after completion of cyclophosphamide infusion) on days 2-6, and topotecan IV continuously on days 2-6. * Consolidation: Patients who achieve complete remission (CR) receive 1 additional course of induction therapy on the same arm to which they were originally randomized beginning within 4-6 weeks after initial documentation of CR. Patients on arm II receive no additional daunorubicin liposomal if resting ejection fraction is less than 50% preconsolidation. All patients receive sargramostim (GM-CSF) IV over 4 hours or SQ daily beginning 24 hours after completion of consolidation therapy and continuing until blood counts recover. Patients are followed every 3 months through year 2, every 6 months through year 5, and then annually thereafter until death. PROJECTED ACCRUAL: A maximum of 150-165 patients (50-55 per arm) will be accrued for this study within 2 years.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

CCOP - Scottsdale Oncology Program, Scottsdale, Arizona, United States

Cancer Center and Beckman Research Institute, City of Hope, Duarte, California, United States

Veterans Affairs Medical Center - Palo Alto, Palo Alto, California, United States

Stanford University Medical Center, Stanford, California, United States

CCOP - Colorado Cancer Research Program, Inc., Denver, Colorado, United States

CCOP - Christiana Care Health Services, Wilmington, Delaware, United States

Veterans Affairs Medical Center - Gainsville, Gainesville, Florida, United States

Veterans Affairs Medical Center - Miami, Miami, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida, United States

Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States

Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois, United States

CCOP - Central Illinois, Decatur, Illinois, United States

CCOP - Evanston, Evanston, Illinois, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States

CCOP - Carle Cancer Center, Urbana, Illinois, United States

Indiana University Cancer Center, Indianapolis, Indiana, United States

Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis, Indiana, United States

CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States

Holden Comprehensive Cancer Center at The University of Iowa, Iowa City, Iowa, United States

MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States

CCOP - Ochsner, New Orleans, Louisiana, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

New England Medical Center Hospital, Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

CCOP - Ann Arbor Regional, Ann Arbor, Michigan, United States

CCOP - Kalamazoo, Kalamazoo, Michigan, United States

CCOP - Duluth, Duluth, Minnesota, United States

Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, United States

University of Minnesota Cancer Center, Minneapolis, Minnesota, United States

Mayo Clinic Cancer Center, Rochester, Minnesota, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States

Veterans Affairs Medical Center - Omaha, Omaha, Nebraska, United States

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States

Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, United States

CCOP - Northern New Jersey, Hackensack, New Jersey, United States

Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

Albert Einstein Comprehensive Cancer Center, Bronx, New York, United States

MBCCOP-Our Lady of Mercy Cancer Center, Bronx, New York, United States

Veterans Affairs Medical Center - Brooklyn, Brooklyn, New York, United States

Veterans Affairs Medical Center - New York, New York, New York, United States

NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, United States

University of Rochester Cancer Center, Rochester, New York, United States

CCOP - Merit Care Hospital, Fargo, North Dakota, United States

Ireland Cancer Center, Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States

CCOP - Columbus, Columbus, Ohio, United States

CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio, United States

CCOP - Oklahoma, Tulsa, Oklahoma, United States

Hahnemann University Hospital, Philadelphia, Pennsylvania, United States

University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States

Veterans Affairs Medical Center - Pittsburgh, Pittsburgh, Pennsylvania, United States

CCOP - MainLine Health, Wynnewood, Pennsylvania, United States

CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, United States

Veterans Affairs Medical Center - Madison, Madison, Wisconsin, United States

University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States

CCOP - Marshfield Medical Research and Education Foundation, Marshfield, Wisconsin, United States

MBCCOP - San Juan, San Juan, , Puerto Rico

Veterans Affairs Medical Center - San Juan, San Juan, , Puerto Rico

Pretoria Academic Hospitals, Pretoria, , South Africa

Contact Details

Name: Mark R. Litzow, MD

Affiliation: Mayo Clinic

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: