- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00822094
Trial of CPX-351 in Adult Patients With First Relapse Acute Myeloid Leukemia (AML)
Phase IIB, Multicenter, Randomized, Open-Label Trial Of CPX-351 (Cytarabine : Daunorubicin) Liposome Injection Versus Intensive Salvage Therapy In Adult Patients ≤ 65 Years Old With AML In First Relapse Following An Initial CR > 1 Month Duration
The study investigates if CPX-351 will be a) more effective than the standard intensive salvage AML treatment and b) more tolerable than the standard intensive salvage treatment regimens.
The study compares the investigational product CPX-351 vs the standard intensive salvage treatment for first relapse AML patients.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This study is a randomized, open-label, parallel-arm, fixed-dose, standard therapy controlled Phase IIB trial. Study enrollment duration is expected to be approximately 12-18 months. On entry, patients are randomized to receive either CPX-351 or intensive first salvage treatment.
Patients are stratified to balance the likelihood of obtaining a CR and the duration of CR between the two arms.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
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Lille Cedex, Frankrike, 59037
- Service des Maladies du Sang CHU de Lille, Hopital Claude Huriez
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Pessac, Frankrike, 33604
- Service des Maladies du Sang Hopital Haut-Leveque
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Toulouse Cedex 09, Frankrike, 31059
- Service d'Hématologie CHU Toulouse-Hôpital Purpan
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Vandoeuvre les Nancy Cedex, Frankrike, 54511
- Service d'Hématologie et Médecine Interne CHU de Nancy-Hôpital de Brabois
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Arizona
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Tucson, Arizona, Förenta staterna, 85724
- Arizona Cancer Center
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California
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Los Angeles, California, Förenta staterna, 90048
- Cedars Sinai Medical Center
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Los Angeles, California, Förenta staterna, 90024
- UCLA
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Sacramento, California, Förenta staterna, 95817
- UC Davis Cancer Center
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Colorado
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Aurora, Colorado, Förenta staterna, 80045
- University of Colorado Cancer Center
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Illinois
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Chicago, Illinois, Förenta staterna, 60612
- Rush University Medical Center
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Chicago, Illinois, Förenta staterna, 60611
- Northwestern University Robert H. Lurie Comprehensive Cancer Center
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Chicago, Illinois, Förenta staterna, 60637
- University of Chicago Medical Center Section of Hematology/Oncology
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Indiana
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Beech Grove, Indiana, Förenta staterna, 46107
- St. Francis Cancer Center
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Kentucky
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Louisville, Kentucky, Förenta staterna, 40202
- University of Louisville Brown Cancer Center
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Maine
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Waterville, Maine, Förenta staterna, 04901
- Maine General Medical Center Harold Alfond Center for Cancer Care
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Maryland
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Baltimore, Maryland, Förenta staterna, 21231
- Johns Hopkins University
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Missouri
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Saint Louis, Missouri, Förenta staterna, 63101
- St. Louis University Medical Center
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New Jersey
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Hackensack, New Jersey, Förenta staterna, 07601
- The Cancer Center, Hackensack University Medical Center
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New York
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Lake Success, New York, Förenta staterna, 11042
- North Shore LIJ Center for Advanced Medicine Monter Cancer Center
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New York, New York, Förenta staterna, 10021
- Weil Cornell Medical Center
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New York, New York, Förenta staterna, 10595
- New York Medical College
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The Bronx, New York, Förenta staterna, 10467
- Montefiore Medical Center
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North Carolina
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Charlotte, North Carolina, Förenta staterna, 28204
- Blumenthal Cancer Center/Mecklenburg Medical Group
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Durham, North Carolina, Förenta staterna, 27710
- Duke Comprehensive Cancer Center
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Ohio
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Cincinnati, Ohio, Förenta staterna
- Jewish Hospital of Cincinatti
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Oregon
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Portland, Oregon, Förenta staterna, 97239
- Oregon Health and Science University
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Pennsylvania
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Bethlehem, Pennsylvania, Förenta staterna, 18105
- Oncology and Hematology at Lehigh Valley
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Pittsburgh, Pennsylvania, Förenta staterna, 15224
- Western Pennsylvania Hospital
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Texas
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Galveston, Texas, Förenta staterna, 77555
- UTMB Comprehensive Cancer Center
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Houston, Texas, Förenta staterna, 77030
- M.D. Anderson Cancer Center
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Lubbock, Texas, Förenta staterna, 79410
- Joe Arrington Cancer Center
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Lubbock, Texas, Förenta staterna, 79415
- Texas Tech University Health Sciences Center
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San Antonio, Texas, Förenta staterna, 78229
- Cancer Therapy and Research Center at The University of TX Health Science Center
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Utah
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Salt Lake City, Utah, Förenta staterna, 84143
- Intermountain LDS Hospital
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Wisconsin
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Milwaukee, Wisconsin, Förenta staterna, 53226
- Medical College of Wisconsin
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British Columbia
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Vancouver, British Columbia, Kanada, V5Z 1M9
- Vancouver General Hospital/ British Columbia Cancer Agency
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Manitoba
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Winnipeg, Manitoba, Kanada, R3E 049
- Cancer Care Manitoba
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Gdansk, Polen, 80-952
- Klinika Hematologii i Transplantologii
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Lodz, Polen, 93-510
- Wojewodzki Szpital Specjalistyczny im. M. Kopernika
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Opole, Polen, 45-372
- Oddział Hematologii
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Warszawa, Polen, 02-776
- Instytut Hematologii i Transfuzjologii
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Wroclaw, Polen, 50-367
- Akademia Medyczna we Wroclawlu
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Ability to understand and voluntarily sign an informed consent form
- Age ≥18 and ≤65 years at the time of relapse
- Pathological confirmation of relapsed AML after initial CR of >1 month duration
- Eastern Cooperative Oncology Group (ECOG) performance status 0- 2
- Able to adhere to the study visit schedule and other protocol requirements
Laboratory values fulfilling the following:
- Serum creatinine < 2.0 mg/dL
- Serum total bilirubin < 2.0 mg/dL
- Serum alanine aminotransferase or aspartate aminotransferase <3xULN Note: If elevated liver enzymes are related to disease; contact medical monitor to discuss.
- Cardiac ejection fraction > 50% by echocardiography or MUGA scan
- All men and women must agree to practice effective contraception during the study period and for 3 months afterward if not otherwise documented to be infertile.
Exclusion Criteria:
- Patients with active second malignancies are excluded. Patients with second malignancies in remission may be eligible if there is no clinical evidence of active disease, documented by imaging, with tumor marker studies, etc., at screening. Patients maintained on long-term non-chemotherapy treatment, e.g., hormonal therapy, are eligible. In all cases, the second malignancy and its non-chemotherapy treatment must not interfere with the investigators ability to assess the safety or efficacy of the study treatment
- Patients with acute promyelocytic leukemia [t(15;17)]
- Total lifetime anthracycline exposure exceeding the equivalent of 368 mg/m2 of daunorubicin (or equivalent) prior to start of study therapy
- Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent
- Administration of any antineoplastic therapy within 4 weeks of therapy; intended to treat first relapse. In the event of rapidly proliferative disease use of hydroxyurea is permitted until 24 hours before the start of study treatment
- Clinical evidence of active CNS leukemia
- Patients with history of and/or current evidence of myocardial impairment (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in New York Heart Association Class III or IV staging
- Active and uncontrolled infection. Patients with a bacterial infection receiving treatment with antibiotics may be entered into the study if they are afebrile and hemodynamically stable for >72 hrs.
- Current evidence of invasive fungal infection (blood or tissue culture); active hepatitis C infection or known HIV infection
- Hypersensitivity to cytarabine, daunorubicin or liposomal products
- History of Wilson's disease or other copper-related disorder
- Patients with a history of severe toxicity related to receiving conventional dose cytarabine in first line treatment (approximately 100mg/m2/d for <7 days) are excluded. Patients who experienced unacceptable toxicities while receiving high dose cytarabine (approximately 3000mg/m2 for 6 doses) will not be treated again with the same regimen, but could be randomized to treatment with conventional dose cytarabine regimens where the risk of major toxicity is less.
- Woman who are pregnant or breast feeding
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: CPX-351 (Arm A)
First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion
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Aktiv komparator: Salvage Therapy (Arm B)
First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Proportion of Subjects Surviving at 1 Year
Tidsram: Up to 1 year from randomization
|
The proportion of subjects surviving at 1 year was evaluated separately for each arm by the number of subjects alive at 1 year divided by the total number of subjects.
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Up to 1 year from randomization
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Complete Remission Rate
Tidsram: Following 1st induction, following 2nd induction if applicable
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Following 1st induction, following 2nd induction if applicable
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Event Free Survival
Tidsram: Up to 1 year from randomization
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Progression EFS median
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Up to 1 year from randomization
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Remission Duration
Tidsram: Following achievement of CR and up to 1 year from randomization
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Remission duration was measured from the time the criteria for CR were first met until the first date that disease relapse was objectively documented or until subject death.
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Following achievement of CR and up to 1 year from randomization
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Rate of Aplasia
Tidsram: Up to 1 year from randomization
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Patients with Aplasia During Study
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Up to 1 year from randomization
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Rate of Stem Cell Transplant
Tidsram: Up to 1 year from randomization
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Number of patients transferred for stem cell transplant
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Up to 1 year from randomization
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Jonathan Kolitz, MD, North Shore University Hospital
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CLTR0308-205
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