- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00002805
Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
Acute Myeloid Leukemia Salvage Therapy for Patients in First Relapse or Who Fail to Achieve an Initial Remission or Who Develop AML as a Second Malignant Neoplasm
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 with acute myeloid leukemia or myelodysplastic syndrome in first relapse or who did not achieve first remission.
Studieöversikt
Status
Betingelser
Intervention / Behandling
- Läkemedel: mitoxantronhydroklorid
- Läkemedel: kladribin
- Läkemedel: cytarabin
- Läkemedel: etoposid
- Läkemedel: metotrexat
- Läkemedel: terapeutiskt hydrokortison
- Procedur: allogen benmärgstransplantation
- Procedur: stamcellstransplantation av perifert blod
- Biologisk: filgrastim
- Procedur: autolog benmärgstransplantation
- Strålning: låg-LET elektronterapi
- Strålning: low-LET fotonterapi
- Strålning: low-LET kobolt-60 gammastrålningsterapi
Detaljerad beskrivning
OBJECTIVES: I. Determine the toxicity, remission rate, event-free survival, and overall survival following induction with cytarabine/mitoxantrone (ARA-C/DHAD), intensification with ARA-C and etoposide (VP-16), and consolidation with cladribine (2-CdA) and VP-16 in patients with acute myeloid leukemia (AML) that is secondary, in first relapse, or has failed initial remission induction therapy. II. Compare the remission induction rate and event-free survival on this trial with prior second-line studies (i.e., protocols CCG-243, CCG-201, and CCG-261P). III. Compare survival of patients on this trial with the survival of patients relapsing or failing to achieve an initial complete remission (CR) on previous front-line AML trials (i.e., protocols CCG-251, CCG-213, CCG-2861, and CCG-2891). IV. Determine the frequency and prognostic significance of mdr1 gene expression and p53, topoisomerase II, and deoxycytidine kinase gene mutations in these patients. V. Determine the disease-free and overall survival of patients achieving a CR on this study in relation to the post-intensification therapy received (i.e., bone marrow transplantation, chemotherapy, or no further therapy). VI. Determine the frequency and degree of abnormal cardiac function on echocardiogram or MUGA at 1 and 5 years in patients treated with mitoxantrone following anthracycline therapy during initial treatment. VII. Provide a control arm evaluating the safety of using phase I or II agents in an "upfront window" approach planned for future CCG studies. VIII. Determine the toxicity, remission rate, event-free survival, and overall survival in patients who fail to achieve a CR with ARA-C/DHAD induction and are then treated with 2-CdA/VP-16. IX. Determine the biologic characteristics, toxicity, remission rate, event-free survival, and overall survival following this treatment regimen in patients who develop AML as a second malignancy.
OUTLINE: Patients who do not achieve M1/M2a marrow following Induction proceed to Salvage Induction; all others proceed to Intensification. Patients receive Consolidation therapy on Regimen A, B, or C according to the investigator's choice. The following acronyms are used: ARA-C Cytarabine, NSC-63878 2-CdA Cladribine (2-Chlorodeoxyadenosine), NSC-105014 DHAD Mitoxantrone, NSC-301739 G-CSF Filgrastim, NSC-614629 HC Hydrocortisone, NSC-10483 HD High Dose MTX Methotrexate, NSC-740 PBSC Peripheral Blood Stem Cells TBI Total-Body Irradiation TIT Triple Intrathecal Therapy (IT ARA-C/IT HC/IT MTX) VP-16 Etoposide, NSC-141540 INDUCTION: 2-Drug Combination Chemotherapy plus CNS Prophylaxis/Therapy. ARA-C/DHAD; G-CSF; plus IT ARA-C and, if CNS disease at entry, TIT. SALVAGE INDUCTION: 2-Drug Combination Chemotherapy. 2-CdA/VP-16. INTENSIFICATION: 2-Drug Combination Chemotherapy followed, as indicated, by Radiotherapy. HD ARA-C/VP-16; followed, in patients with persistent CNS disease, CNS relapse, or chloromas, by irradiation using megavoltage equipment (minimum Co60 and maximum 6 MV x-rays or electrons). CONSOLIDATION: Regimen A: 2-Drug Combination Chemotherapy. 2-CdA/VP-16. Regimen B: Myeloablative Chemoradiotherapy followed by Hematopoietic Rescue. TBI (equipment unspecified) with electron boosts to the testes, chest, extramedullary sites, and, if indicated, craniospinal region; VP-16; followed by allogeneic or autologous bone marrow or PBSC. Regimen C: No further therapy.
PROJECTED ACCRUAL: A total of 90 patients will be entered. The study may be closed if there are 7 or more deaths in the first 45 patients who complete Intensification.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Western Australia
-
Perth, Western Australia, Australien, 6001
- Princess Margaret Hospital for Children
-
-
-
-
California
-
Long Beach, California, Förenta staterna, 90806
- Long Beach Memorial Medical Center
-
Los Angeles, California, Förenta staterna, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
-
Los Angeles, California, Förenta staterna, 90027-0700
- Children's Hospital Los Angeles
-
Orange, California, Förenta staterna, 92668
- Children's Hospital of Orange County
-
San Francisco, California, Förenta staterna, 94115-0128
- UCSF Cancer Center and Cancer Research Institute
-
-
Colorado
-
Denver, Colorado, Förenta staterna, 80218
- Children's Hospital of Denver
-
-
District of Columbia
-
Washington, District of Columbia, Förenta staterna, 20010-2970
- Children's National Medical Center
-
-
Illinois
-
Chicago, Illinois, Förenta staterna, 60637
- University of Chicago Cancer Research Center
-
-
Indiana
-
Indianapolis, Indiana, Förenta staterna, 46202-5265
- Indiana University Cancer Center
-
-
Iowa
-
Iowa City, Iowa, Förenta staterna, 52242
- University of Iowa Hospitals and Clinics
-
-
Michigan
-
Ann Arbor, Michigan, Förenta staterna, 48109-0752
- University of Michigan Comprehensive Cancer Center
-
Kalamazoo, Michigan, Förenta staterna, 49007-3731
- CCOP - Kalamazoo
-
-
Minnesota
-
Minneapolis, Minnesota, Förenta staterna, 55455
- University of Minnesota Cancer Center
-
Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic Cancer Center
-
-
Missouri
-
Kansas City, Missouri, Förenta staterna, 64108
- Children's Mercy Hospital - Kansas City
-
-
Nebraska
-
Omaha, Nebraska, Förenta staterna, 68198-3330
- University of Nebraska Medical Center
-
-
New Jersey
-
New Brunswick, New Jersey, Förenta staterna, 08901
- Cancer Institute of New Jersey
-
-
New York
-
New York, New York, Förenta staterna, 10021
- Memorial Sloan-Kettering Cancer Center
-
New York, New York, Förenta staterna, 10016
- Kaplan Cancer Center
-
New York, New York, Förenta staterna, 10032
- Herbert Irving Comprehensive Cancer Center
-
-
North Carolina
-
Chapel Hill, North Carolina, Förenta staterna, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
-
-
North Dakota
-
Fargo, North Dakota, Förenta staterna, 58102
- Veterans Affairs Medical Center - Fargo
-
Fargo, North Dakota, Förenta staterna, 58122
- CCOP - Merit Care Hospital
-
-
Ohio
-
Cincinnati, Ohio, Förenta staterna, 45229-3039
- Children's Hospital Medical Center - Cincinnati
-
Cleveland, Ohio, Förenta staterna, 44106-5065
- Ireland Cancer Center
-
Columbus, Ohio, Förenta staterna, 43205-2696
- Children's Hospital of Columbus
-
-
Oregon
-
Portland, Oregon, Förenta staterna, 97201-3098
- Doernbecher Children's Hospital
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Förenta staterna, 19104
- Children's Hospital of Philadelphia
-
Pittsburgh, Pennsylvania, Förenta staterna, 15213
- Children's Hospital of Pittsburgh
-
-
Tennessee
-
Nashville, Tennessee, Förenta staterna, 37232-6838
- Vanderbilt Cancer Center
-
-
Texas
-
Houston, Texas, Förenta staterna, 77030
- University of Texas - MD Anderson Cancer Center
-
-
Utah
-
Salt Lake City, Utah, Förenta staterna, 84132
- Huntsman Cancer Institute
-
-
Washington
-
Seattle, Washington, Förenta staterna, 98109
- Fred Hutchinson Cancer Research Center
-
Seattle, Washington, Förenta staterna, 98105
- Children's Hospital and Medical Center - Seattle
-
-
Wisconsin
-
Madison, Wisconsin, Förenta staterna, 53792
- University of Wisconsin Comprehensive Cancer Center
-
-
-
-
British Columbia
-
Vancouver, British Columbia, Kanada, V6H 3V4
- British Columbia Children's Hospital
-
-
Nova Scotia
-
Halifax, Nova Scotia, Kanada, B3J 3G9
- IWK Grace Health Centre
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS: Acute myeloid leukemia (AML) or myelodysplastic syndrome in one of the following categories: In first relapse Failed to achieve initial complete remission Newly diagnosed secondary AML eligible Required bone marrow status: Greater than 25% blasts (M3) OR Persistent abnormal clone on cytogenetics and 5-25% blasts (M2) No Fanconi's anemia
PATIENT CHARACTERISTICS: Age: Under 22 Performance status: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 1.5 times normal AST or ALT less than 4.0 times normal Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance or GFR greater than 70 mL/min per 1.73 square meters or GFR in equivalent institutional normal range Cardiovascular: Shortening fraction greater than 27% by echocardiogram or in institutional normal range OR Ejection fraction greater than 47% by radionuclide angiogram
PRIOR CONCURRENT THERAPY: No more than 1 prior treatment No prior salvage therapy No prior mitoxantrone
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Treatment
Induction will consist of one course of cytarabine and mitoxantrone.
Patients achieving a complete or partial response by the end of induction will start intensification.
Intensification will consist of one course of chemotherapy (Cytarabine (Ara-C), Etoposide (VP-16), Filgrastim (G-CSF)).
Patients who do not attain a CNS remission following the completion of intensification therapy, or who develop recurrence of CNS disease and have not previously received radiation therapy involving the central nervous system should receive craniospinal radiotherapy.
Continuation Therapy: cladribine (2CdA), Etoposide.
|
Andra namn:
Andra namn:
Andra namn:
Andra namn:
Andra namn:
Andra namn:
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Estimate second remission rate and survival rate
Tidsram: 3 years
|
3 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Evaluate the mortality of the start of VP-16/Ara-C intensification
Tidsram: 45 days
|
45 days
|
|
Compare outcomes by the ethnicity and gender
|
Compare outcomes by the ethnicity (and gender) in study CCG-2951, and will control for ethnicity in multivariate models comparing the treatment arms
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studiestol: Robert J. Wells, MD, Children's Hospital Medical Center, Cincinnati
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 (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter histologisk typ
- Neoplasmer
- Benmärgssjukdomar
- Hematologiska sjukdomar
- Myelodysplastiska syndrom
- Leukemi
- Leukemi, myeloid
- Leukemi, Myeloid, Akut
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Agenter från det perifera nervsystemet
- Antivirala medel
- Nukleinsyrasynteshämmare
- Enzyminhibitorer
- Analgetika
- Sensoriska systemagenter
- Antiinflammatoriska medel
- Antireumatiska medel
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Antineoplastiska medel, fytogena
- Topoisomeras II-hämmare
- Topoisomerasinhibitorer
- Dermatologiska medel
- Spårelement
- Mikronäringsämnen
- Reproduktionskontrollmedel
- Abortframkallande medel, icke-steroida
- Abortmedel
- Folsyraantagonister
- Etoposid
- Cytarabin
- Metotrexat
- Mitoxantron
- Kladribin
- Hydrokortison
- Hydrokortison 17-butyrat 21-propionat
- Hydrokortisonacetat
- Hydrokortison hemisuccinat
- Kobolt
Andra studie-ID-nummer
- 2951
- CCG-2951
- CDR0000064907 (Annan identifierare: Clinical Trials.gov)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Leukemi
-
Massachusetts General HospitalCelgene CorporationAvslutadAkut myelogen leukemi | Akut myeloid leukemi (AML) | Akut myelocytisk leukemi | Akut granulocytisk leukemi | Akut icke-lymfocytisk leukemiFörenta staterna
-
Institute of Hematology & Blood Diseases HospitalBejing Institute for Stem Cell and Regenerative Medicine; Institute for...RekryteringRefraktär leukemi | Återfallande leukemi | Akut myeloid leukemi, barndomKina
-
Betta Pharmaceuticals Co., Ltd.Har inte rekryterat ännuAkut Myeloid Leukemi LeukemiKina
-
GlaxoSmithKlineAvslutadLeukemi, Myelocytisk, AkutFörenta staterna, Australien, Kanada
-
Hybrigenics CorporationOkändAkut myelogen leukemiFörenta staterna, Frankrike
-
Center for International Blood and Marrow Transplant...National Marrow Donor Program; St. Baldrick's FoundationAktiv, inte rekryterandeAkut myelogen leukemiFörenta staterna
-
Massachusetts General HospitalAvslutad
-
Beijing Boren HospitalRekryteringAkut myeloid leukemi | Refraktär Akut Myeloid Leukemi | Återfall leukemiKina
-
Sidney Kimmel Comprehensive Cancer Center at Johns...AvslutadAkut lymfoblastisk leukemi | Akut myelogen leukemi (AML) | Akut lymfatisk leukemi (ALL) | Akut promyelocytisk leukemi (APL)Förenta staterna
-
Kinex Pharmaceuticals Inc.AvslutadAkut myelogen leukemiFörenta staterna
Kliniska prövningar på mitoxantronhydroklorid
-
M.D. Anderson Cancer CenterIndragenMetastaserande icke-småcelligt lungkarcinom | Steg IVA lungcancer AJCC v8 | Steg IVB lungcancer AJCC v8 | Steg IV lungcancer AJCC v8
-
PD Dr. Andrew ChanOkänd
-
Huijing WuBeijing Xisike Clinical Oncology Research Foundation; CSPC Pharmaceutical...RekryteringAngioimmunoblastiskt T-cellslymfomKina
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.AvslutadAvancerade solida tumörerKina
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.AvslutadAvancerat magkarcinomKina
-
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co....Har inte rekryterat ännuNeuromyelit Optica Spectrum Disorder
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Har inte rekryterat ännuAvancerad bukspottkörtelcancer
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.AvslutadRelapsed Cutaneous T Cell LymphomKina
-
INSYS Therapeutics IncAvslutadTumörerFörenta staterna
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.RekryteringDiffust stort B-cellslymfomKina