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Spots Global Cancer Trial Database for Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia

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Trial Identification

Brief Title: Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia

Official Title: Phase III, Randomized, Multicenter Study to Assess the Efficacy and Safety of HuM195 (Recombinant Humanized Anti-CD33 Monoclonal Antibody) in Combination With Standardized Chemotherapy Compared to Standardized Chemotherapy Alone in the Treatment of Patients With Refractory or First-Relapsed Acute Myelogenous Leukemia (AML)

Study ID: NCT00006045

Conditions

Leukemia

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known if chemotherapy is more effective with or without monoclonal antibody therapy for acute myelogenous leukemia. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without monoclonal antibody therapy in treating patients who have refractory or relapsed acute myelogenous leukemia.

Detailed Description: OBJECTIVES: I. Compare the efficacy, safety, pharmacokinetics, and immunogenicity of mitoxantrone, etoposide, and cytarabine (MEC) with or without monoclonal antibody HuG1-M195 in patients with refractory or relapsed acute myelogenous leukemia. OUTLINE: This is a randomized, multicenter study. Patients are stratified by age (under 50 vs 50 and over) and duration of previous complete remission (CR) (0-6 vs 7-12 months). All patients receive induction chemotherapy comprised of cytarabine IV over 2 hours, mitoxantrone IV over a maximum of 20 minutes, and etoposide IV over 1-2 hours on days 1-6. On day 5 of induction, patients are randomized to one of two treatment arms: Arm I: Patients receive day 6 of induction chemotherapy. Patients then receive monoclonal antibody HuG1-M195 (MOAB HuM195) IV over 4 hours on days 6-9 or 7-10. Treatment with MOAB HuM195 repeats every 2 weeks for 2 courses (courses 1 and 2) in the absence of disease progression or unacceptable toxicity. During course 1, MOAB HuM195 begins 30 minutes to 24 hours postchemotherapy. Patients who do not achieve CR by day 70 of induction and show evidence of bone marrow progression (regimen failure (RF)) are taken off study. Patients without RF are assigned to one of two consolidation groups based on response: Group A (CR): Patients receive consolidation chemotherapy comprised of mitoxantrone IV over a maximum of 20 minutes on days 1 and 2, and cytarabine IV over 2 hours and etoposide IV over 1-2 hours on days 1-4. Patients with New York Heart Association class II heart disease preconsolidation receive no mitoxantrone during consolidation. Patients receive MOAB HuM195 IV over 4 hours on days 4-7 or 5-8. Treatment with MOAB HuM195 repeats every 2 weeks for 2 additional courses (courses 3 and 4). During course 3, MOAB HuM195 begins 30 minutes to 24 hours postchemotherapy. Group B (partial remission (PR), hematologic improvement (HI), or stable disease (SD)): Patients receive MOAB HuM195 as in group A but no consolidation chemotherapy. Patients without RF after treatment on group A or B receive maintenance MOAB HuM195 IV over 4 hours on days 1-4. Treatment repeats every month for 8 additional courses (courses 5-12). Arm II: Patients receive day 6 of induction chemotherapy. Patients receive no MOAB HuM195 during the entire study. Patients without RF at day 70 of induction are assigned to one of two consolidation groups based on response: Group C (CR): Patients receive consolidation chemotherapy as in group A. Group D (PR, HI, or SD): Patients receive no further treatment. Patients may be eligible to receive MOAB HuM195 on PDL Study 195-302. Patients are followed every 3 months for 1 year, and then every 6 months thereafter. PROJECTED ACCRUAL: A maximum of 200 patients (100 per arm) will be accrued for this study.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States

Beckman Research Institute, City of Hope, Los Angeles, California, United States

St. Joseph Hospital - Orange, Orange, California, United States

Sutter Cancer Center, Sacramento, California, United States

University of California Davis Cancer Center, Sacramento, California, United States

Sidney Kimmel Cancer Center, San Diego, California, United States

Washington Cancer Institute, Washington, District of Columbia, United States

Emory Clinic, Atlanta, Georgia, United States

University of Illinois at Chicago, Chicago, Illinois, United States

Loyola University Medical Center, Maywood, Illinois, United States

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States

Louisiana State University School of Medicine, Shreveport, Louisiana, United States

Johns Hopkins Oncology Center, Baltimore, Maryland, United States

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

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

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

West Michigan Cancer Center, Kalamazoo, Michigan, United States

North Mississippi Hematology and Oncology Associates, Ltd., Tupelo, Mississippi, United States

Washington University Barnard Cancer Center, Saint Louis, Missouri, United States

Nevada Cancer Center, Las Vegas, Nevada, United States

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

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

Roswell Park Cancer Institute, Buffalo, New York, United States

North Shore University Hospital, Manhasset, New York, United States

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

New York Presbyterian Hospital - Cornell Campus, New York, New York, United States

New York Medical College, Valhalla, New York, United States

Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States

Duke Comprehensive Cancer Center, Durham, North Carolina, United States

Akron General Medical Center, Akron, Ohio, United States

Ireland Cancer Center, Cleveland, Ohio, United States

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

Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States

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

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States

West Clinic, P.C., Memphis, Tennessee, United States

Vanderbilt University Medical Center, Nashville, Tennessee, United States

Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Algemeen Ziekenhuis Middelheim, Antwerp, , Belgium

Institut Jules Bordet, Brussels, , Belgium

U.Z. Gasthuisberg, Leuven, , Belgium

Cross Cancer Institute, Edmonton, Alberta, Canada

Health Sciences Centre, Winnipeg, Manitoba, Canada

Queen Elizabeth II Health Science Center, Halifax, Nova Scotia, Canada

Princess Margaret Hospital, Toronto, Ontario, Canada

Centre Hospitalier Regional et Universitaire d'Angers, Angers, , France

CHRU de Nancy - Hopitaux de Brabois, Vandoeuvre-Les-Nancy, , France

Universitaetsklinikum Benjamin Franklin, Berlin, , Germany

Klinikum der J.W. Goethe Universitaet, Frankfurt, , Germany

Klinikum Rechts Der Isar/Technische Universitaet Muenchen, Munich, , Germany

Westfaelische Wilhelms-Universitaet, Munster, , Germany

University of Rostock, Rostock, , Germany

Academisch Medisch Centrum, Amsterdam, , Netherlands

Addenbrooke's NHS Trust, Cambridge, England, United Kingdom

Royal Free Hospital, Hampstead, London, England, United Kingdom

Leeds Teaching Hospital Trust, Leeds, England, United Kingdom

Christie Hospital N.H.S. Trust, Manchester, England, United Kingdom

Contact Details

Name: Daniel Levitt, MD, PhD

Affiliation: Facet Biotech

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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