Cytarabine With or Without VNP40101M in Treating Patients With Relapsed Acute Myeloid Leukemia
NCT ID: NCT00112554
Last Updated: 2013-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
420 participants
INTERVENTIONAL
2005-03-31
2008-03-31
Brief Summary
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PURPOSE: This randomized phase III trial is studying cytarabine and VNP40101M to see how well they work compared to cytarabine alone in treating patients with relapsed acute myeloid leukemia.
Detailed Description
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Primary
* Compare the complete response (CR) and CR (with platelet count \< 100,000/mm\^3 but ≥ 20,000/mm\^3 \[transfusion independent for ≥ 7 consecutive days\]) (CRp) rates in patients with acute myeloid leukemia in first relapse treated with cytarabine with vs without VNP40101M.
Secondary
* Compare time to progression in patients treated with these regimens.
* Compare duration of response in patients treated with these regimens.
* Compare the survival of patients treated with these regimens.
* Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel group, multicenter study. Patients are stratified according to age (\< 60 years vs ≥ 60 years) and duration of first complete response (CR) or CR (with platelet count \< 100,000/mm³ but ≥ 20,000/mm³ \[transfusion independent for ≥ 7 consecutive days\]) (CRp) (\< 12 months vs ≥ 12 months).
* Induction therapy: Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive cytarabine IV continuously on days 1-3 and VNP40101M IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine).
* Arm II: Patients receive cytarabine as in arm I and placebo IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine).
In both arms, patients demonstrating at least 20% reduction of blasts in bone marrow (based on total cellularity and percent blasts) after course 1 may receive 1 additional course of induction therapy between days 35-60 in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp after 1 or 2 courses of induction therapy proceed to consolidation therapy.
* Consolidation therapy: Beginning 6 weeks after initial documentation of CR or CRp, patients receive 1 course of consolidation therapy, as per induction therapy, according to their randomized treatment arm. These patients may then proceed to other consolidation, maintenance, and/or intensification therapy (including stem cell transplantation) off study at the discretion of the physician.
After completion of study treatment, patients are followed monthly for 6 months, every 2 months for 6 months, and then every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 420 patients (280 in arm I and 140 in arm II) will be accrued for this study within 24-30 months.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
DOUBLE
Study Groups
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Induction therapy arm I
Patients receive cytarabine IV continuously on days 1-3 and VNP40101M IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine).
cytarabine
Given IV
laromustine
Given IV
Induction therapy arm II
Patients receive cytarabine as in arm I and placebo IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine).
cytarabine
Given IV
placebo
Given IV
Interventions
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cytarabine
Given IV
laromustine
Given IV
placebo
Given IV
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed acute myeloid leukemia (AML)
* Any WHO classification, excluding acute promyelocytic leukemia
* At least 10% blasts by bone marrow aspirate and/or biopsy
* In first relapse after achieving a first complete response (CR) OR CR (with platelet count \< 100,000/mm³ but ≥ 20,000/mm³ \[transfusion independent for ≥ 7 consecutive days\]) (CRp) that lasted ≥ 3 months but ≤ 24 months after completion of the initial induction regimen
* Relapse confirmed by recurrence of blasts in peripheral blood, bone marrow histopathology, and/or histologically confirmed CNS or extramedullary disease
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* See Disease Characteristics
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST ≤ 3 times ULN
* Chronic hepatitis allowed
Renal
* Creatinine ≤ 2.0 mg/dL
Cardiovascular
* No myocardial infarction within the past 3 months
* No uncontrolled arrhythmias
* No uncontrolled congestive heart failure
Pulmonary
* No severe chronic obstructive pulmonary disease
* No requirement for supplemental oxygen at rest
Immunologic
* No uncontrolled active infection
* Infections that are controlled and under active treatment with antibiotics allowed
* No evidence of invasive fungal infection by blood or tissue cultures
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
* No clinical evidence of another active malignancy by tumor marker, pathology, or radiologic studies
* No other severe medical condition that would preclude study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* At least 12 hours since prior hydroxyurea
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* No prior treatment while in first relapse except hydroxyurea
* No other concurrent standard or investigational treatment for AML
* No concurrent disulfiram (Antabuse®)
18 Years
ALL
No
Sponsors
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Vion Pharmaceuticals
INDUSTRY
Principal Investigators
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Bonny L. Johnson, RN, MSN
Role:
Vion Pharmaceuticals
Locations
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USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
American Health Network - North Meridian
Indianapolis, Indiana, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
Nevada Cancer Institute
Las Vegas, Nevada, United States
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
New York Medical College
Valhalla, New York, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Brody School of Medicine at East Carolina University
Greenville, North Carolina, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
CHU Charleroi - Site Vesale
Montigny-le-Tilleul, , Belgium
Vancouver Hospital and Health Science Center
Vancouver, British Columbia, Canada
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, Canada
Capital District Health Authority Center for Clinical Research
Halifax, Nova Scotia, Canada
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, , France
Hopital Edouard Herriot
Lyon, , France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, , France
CHR Hotel Dieu
Nantes, , France
Hopital Haut Leveque
Pessac, , France
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, , Germany
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, , Germany
Universitaetsfrauenklinik Frankfurt
Frankfurt, , Germany
Universitatsklinikum Heidelberg
Heidelberg, , Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, , Germany
Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
Münster, , Germany
University Wurzburg
Würzburg, , Germany
Evaggelismos Hospital
Athens, , Greece
University of Patras Medical School
Rio Patras, , Greece
University Medical Center Groningen
Groningen, , Netherlands
Medical University of Gdansk
Gdansk, , Poland
Medical University of Lodz
Lodz, , Poland
Centrum Onkologii Ziemi Lubelskiez
Lublin, , Poland
Wojskowy Instytut Medyczny
Warsaw, , Poland
Institute of Haematology and Blood Transfusion
Warsaw, , Poland
Clinical Centre of Serbia
Belgrade, , Serbia
Clinical Centre Nis
Niš, , Serbia
Clinic Centre Novi Sad
Novi Sad, , Serbia
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
King's College Hospital
London, England, United Kingdom
Manchester Royal Infirmary
Manchester, England, United Kingdom
University Hospital of Wales
Cardiff, Wales, United Kingdom
Countries
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References
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Giles F, Vey N, DeAngelo D, Seiter K, Stock W, Stuart R, Boskovic D, Pigneux A, Tallman M, Brandwein J, Kell J, Robak T, Staib P, Thomas X, Cahill A, Albitar M, O'Brien S. Phase 3 randomized, placebo-controlled, double-blind study of high-dose continuous infusion cytarabine alone or with laromustine (VNP40101M) in patients with acute myeloid leukemia in first relapse. Blood. 2009 Nov 5;114(19):4027-33. doi: 10.1182/blood-2009-06-229351. Epub 2009 Aug 26.
Giles FJ, Stock W, Vey N, et al.: A double blind placebo-controlled randomized phase III study of high dose continuous infusion cytosine arabinoside (araC) with or without cloretazine in patients with first relapse of acute myeloid leukemia (AML). [Abstract] Blood 108 (11): A-1970, 2006.
Other Identifiers
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VION-CLI-037
Identifier Type: -
Identifier Source: secondary_id
CDR0000430677
Identifier Type: -
Identifier Source: org_study_id