- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00798213
SCH 727965 in Patients With Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia (P04717AM2)(TERMINATED)
3. februar 2015 opdateret af: Merck Sharp & Dohme LLC
A Phase 2 Study of SCH 727965 in Subjects With Relapsed and Refractory Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia
Participants with acute myelogenous leukemia (AML) will be randomized to SCH 727965 or gemtuzumab ozogamicin.
All participants with acute lymphoblastic leukemia (ALL) will receive SCH 727965.
Part 1 of the study will determine the activity of SCH 727965 treatment in participants with AML and participants with ALL.
Part 2 of the study will determine the activity of SCH 727965 treatment in participants with AML who experienced disease progression after standard treatment with gemtuzumab ozogamicin during Part 1.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
29
Fase
- Fase 2
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
For participants with AML:
- Age >=60 years, either sex, any race.
- Diagnosis of CD33-positive AML by World Health Organization criteria.
- Must be in first or second relapse, or have primary refractory or refractory disease at first salvage, and not be considered a candidate for transplant.
- Acute promyelocytic leukemia who has relapsed following treatment with both all trans retinoic acid (tretinoin) and arsenic trioxide-based therapy is eligible.
For participants with ALL:
- Age >=18 years, either sex, any race.
- Diagnosis of ALL by World Health Organization criteria.
- Must be in first or second relapse, or have primary refractory or refractory disease at first salvage, and not be considered a candidate for potentially curative therapy.
- Eastern Cooperative Oncology group performance status of 0 or 1.
- Adequate hematologic, renal, and hepatic organ function and laboratory parameters.
- Receiving treatment with hydroxyurea or leukapheresis to reduce elevated white blood cell count to <=30 x 10^9 is eligible, provided hydroxyurea and leukapheresis are discontinued at least 24 hours before initiation of study drug.
Exclusion Criteria:
- Known central nervous system leukemia.
- Previous hematopoietic stem cell transplantation.
- Previous treatment with SCH 727965 or other cyclin-dependent kinase inhibitors.
- For AML, previous treatment with gemtuzumab ozogamicin.
- Known HIV infection.
- Known active hepatitis B or C.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Participants with AML randomized to SCH 727965
|
SCH 727965 50 mg/m2 IV on Day 1 of each 21 day cycle until disease progression.
|
Aktiv komparator: Participants with AML randomized to gemtuzumab ozogamicin
|
Gemtuzumab ozogamicin 9 mg/m2 IV on Day 1 and Day 15.
Andre navne:
|
Eksperimentel: AML treated w/ SCH 727965 after prog. on gemtuzumab ozogamicin
|
SCH 727965 50 mg/m2 IV on Day 1 of each 21 day cycle until disease progression.
|
Eksperimentel: Participants with ALL treated with SCH 727965
|
SCH 727965 50 mg/m2 IV on Day 1 of each 21 day cycle until disease progression.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Overall response rate of initial treatment with SCH 727965 in subjects with AML or ALL.
Tidsramme: Time to identified response or disease progression on SCH 727965 in Part 1 (approx. 5 months).
|
Time to identified response or disease progression on SCH 727965 in Part 1 (approx. 5 months).
|
Overall response rate in participants with AML treated with SCH 727965 after disease progression on comparator.
Tidsramme: Time to identified response or disease progression on SCH 727965 in Part 2 (approx. 5 months).
|
Time to identified response or disease progression on SCH 727965 in Part 2 (approx. 5 months).
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Time to disease progression for initial treatment with SCH 727965 in subjects with AML or ALL.
Tidsramme: Time to identified disease progression on SCH 727965 in Part 1 (approx. 5 months).
|
Time to identified disease progression on SCH 727965 in Part 1 (approx. 5 months).
|
Overall response rate and time to progression of treatment with gemtuzumab ozogamicin in subjects with AML.
Tidsramme: Time to identified response or disease progression on gemtuzumab ozogamicin (approx. 5 months).
|
Time to identified response or disease progression on gemtuzumab ozogamicin (approx. 5 months).
|
Time to disease progression for treatment with gemtuzumab ozogamicin in participants with AML.
Tidsramme: Time to identified disease progression on gemtuzumab ozogamicin (approx. 5 months).
|
Time to identified disease progression on gemtuzumab ozogamicin (approx. 5 months).
|
Time to disease progression in participants with AML treated with SCH 727965 after disease progression on gemtuzumab ozogamicin
Tidsramme: Time to identified disease progression on SCH 727965 in Part 2 (approx. 5 months).
|
Time to identified disease progression on SCH 727965 in Part 2 (approx. 5 months).
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2009
Primær færdiggørelse (Faktiske)
1. april 2010
Studieafslutning (Faktiske)
1. april 2010
Datoer for studieregistrering
Først indsendt
25. november 2008
Først indsendt, der opfyldte QC-kriterier
25. november 2008
Først opslået (Skøn)
26. november 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
4. februar 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. februar 2015
Sidst verificeret
1. februar 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesygdomme
- Immunproliferative lidelser
- Leukæmi
- Leukæmi, myeloid
- Leukæmi, Myeloid, Akut
- Precursorcelle lymfoblastisk leukæmi-lymfom
- Leukæmi, lymfoid
- Antineoplastiske midler
- Antineoplastiske midler, immunologiske
- Gemtuzumab
Andre undersøgelses-id-numre
- P04717
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Leukæmi, Myeloid, Akut
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Ascentage Pharma Group Inc.Suzhou Yasheng Pharmaceutical Co., Ltd.RekrutteringMyeloid malignitet | Recidiverende/Refraktær Akut Myeloid LeukæmiKina
-
University of PennsylvaniaAktiv, ikke rekrutterendeAkut myeloid leukæmi, i tilbagefald | Akut myeloid leukæmi, refraktær | Akut myeloid leukæmi, pædiatriskForenede Stater
-
University of WashingtonAfsluttetTilbagevendende akut myeloid leukæmi | Refraktær akut myeloid leukæmi | Myeloid neoplasmaForenede Stater
-
Washington University School of MedicineTrukket tilbageRefraktær akut myeloid leukæmi | Recidiverende akut myeloid leukæmiForenede Stater
-
C. Babis AndreadisGateway for Cancer Research; AVEO Pharmaceuticals, Inc.AfsluttetAkut myeloid leukæmi | Refraktær akut myeloid leukæmi | Recidiverende akut myeloid leukæmiForenede Stater
-
Children's Oncology GroupNational Cancer Institute (NCI)AfsluttetAkut myeloid leukæmi i barndommen/andre myeloid malignitetForenede Stater
-
Xuzhou Medical UniversityRekrutteringAkut myeloid leukæmi, i tilbagefald | Akut myeloid leukæmi refraktærKina
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.RekrutteringNydiagnosticeret akut myeloid leukæmi (AML)Kina
-
Peking University People's HospitalBeijing JD Biotech Co. LTD.RekrutteringAkut myeloid leukæmi, i tilbagefald | Akut myeloid leukæmi refraktærKina
-
Xuzhou Medical UniversityRekrutteringAkut myeloid leukæmi, i tilbagefald | Akut myeloid leukæmi refraktærKina
Kliniske forsøg med SCH 727965
-
Merck Sharp & Dohme LLCAfsluttetLymfom, Non-Hodgkin | Myelomatose | Faste tumorer | Leukæmi, lymfatisk, kronisk. B-celle
-
National Cancer Institute (NCI)Aktiv, ikke rekrutterendeFase IV kutan melanom AJCC v6 og v7 | Tilbagevendende melanom | Lentigo Maligna melanom | Slimhinde melanom | Akralt lentiginøst melanom | Kutant nodulært melanom | Lav-CSD melanomForenede Stater
-
National Cancer Institute (NCI)AfsluttetStadie IV melanom | Stadie IIIB melanom | Stadie IIIC melanomForenede Stater
-
National Cancer Institute (NCI)AfsluttetRefraktær MyelomForenede Stater, Singapore
-
National Cancer Institute (NCI)Aktiv, ikke rekrutterendeAvanceret malignt fast neoplasmaForenede Stater
-
National Cancer Institute (NCI)AfsluttetKronisk lymfatisk leukæmi | Tilbagevendende lille lymfocytisk lymfom | Prolymfocytisk leukæmi | Refraktær kronisk lymfatisk leukæmiForenede Stater
-
Merck Sharp & Dohme LLCAfsluttetKronisk lymfatisk leukæmi (CLL)
-
AbbVieMerck Sharp & Dohme LLCAfsluttetKræft - Akut myeloid leukæmiForenede Stater, Australien, Spanien
-
Merck Sharp & Dohme LLCAfsluttetLymfom, kappecelle | Leukæmi, lymfatisk, kronisk, B-celle
-
National Cancer Institute (NCI)AfsluttetTilbagevendende brystkarcinom | Østrogenreceptor negativ | HER2/Neu negativ | Progesteronreceptor negativ | Triple-negativt brystkarcinom | Mandligt brystkarcinom | Stage IV brystkræft AJCC v6 og v7Forenede Stater