- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01310010
Study of Dasatinib to Treat Philadelphia Positive Acute Lymphoblastic Leukemia (DASA-TRAS)
Multicenter, Non-randomized Phase II Pilot Study to Assess the Efficacy and Safety of Dasatinib After Allogeneic Stem Cell Transplantation in Patients With de Novo Philadelphia Positive (Bcr-abl +) Acute Lymphoblastic Leukemia
Study hypothesis:
Treatment with dasatinib 100 mg QD is safe and efficacious when given to patients with Ph+ ALL in the post SCT setting.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Participants - inclusion criteria
- Adult patients ≥ 18 years.
- Diagnostic confirmation of de novo Ph+ ALL.
- Patients in first/second CR (assessed by cytology, karyotyping and/or FISH) at transplantation.
- Patients with sustained hematologic and cytogenetic CR at the time of study entry.
- Any modality of allogeneic SCT.
- Patients are in days between 120 until 180 after allogeneic SCT with stable graft.
- Ability to understand and voluntarily sign the informed consent form.
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy and have a negative pregnancy test, a maximum of 48 hours prior to study drug start.
Participants - exclusion criteria:
- Patients with ECOG 3-4 at study entry
Any of the following laboratory abnormalities:
- Absolute neutrophil count < 1.5 x 109/l or platelets < 75 x 109/l
- Serum creatinine > 2.0 mg/dl (177 mmol/l).
- Serum glutamic oxalacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) > 5,0 x upper limit of normal (ULN).
- Total bilirubin > 3 mg/dl.
- Known HIV infection or any other uncontrolled infection at study entry
- Known pleural effusion of any grade at study entry.
- Morphologic or cytogenetic or molecular relapse at study entry
- Evidence of digestive dysfunction that could prevent administration of study therapy
- Prior therapy with dasatinib during >21 days
- Other concurrent malignancy at study entry
- Uncontrolled or significant cardiovascular disease, including myocardial infarction within 6 months, uncontrolled angina within 3 months, prolonged QT interval, congestive heart failure within 3 months and clinically significant ventricular arrhythmias
- Any psychiatric condition that could prevent patient from signing the informed consent o could put the patient at an unacceptable risk in case of participating in the trial
- Subjects enrolled in another clinical trial at study entry. If patients have received other investigational agent, a minimum of 30 days wash-out period must have elapsed.
Primary Outcome measures
The primary objective of this study is to assess the efficacy of dasatinib maintenance in terms of Disease Free Survival at 2 years in patients with Ph+ ALL who receive maintenance with dasatinib after allogeneic SCT.
Secondary Outcome measures
.To assess the efficacy of maintenance with dasatinib in terms of duration of hematologic, cytogenetic and molecular remission, Relapse rate at 2 years, survival at 2 years, overall DFS, and Overall Survival (OS).
·To assess the safety and tolerability of dasatinib maintenance regimen after allogeneic SCT
Regarding the secondary objective "To assess the safety and tolerability of dasatinib maintenance regimen after allogeneic SCT", such safety analysis includes the frequency of all adverse events and laboratory abnormalities as well as frequency of dose interruptions, dose reductions and treatment discontinuation for drug-related toxicity. Frequency tables will be reported using the "All treated subjects" dataset. Safety will be reported for all treated patients and assessed by baseline findings, AEs and SAEs (definition, pattern, seriousness and intensity according to NCI CTCAE v3.0, relationship with dasatinib and outcome). Hematologic toxicity will be analyzed separately.
Studietype
Registrering (Forventet)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
-
Valencia, Spania, 46009
- Hospital la Fe
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Adult patients ≥ 18 years
- Diagnostic confirmation of de novo Ph+ ALL
- Patients in first/second CR (assessed by cytology, karyotyping and/or FISH) at transplantation
- Patients with sustained hematologic and cytogenetic CR at the time of study entry
- Any modality of allogeneic SCT
- Patients are in days between 120 until 180 after allogeneic SCT with stable graft.
- Ability to understand and voluntarily sign the informed consent form
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy and have a negative pregnancy test, a maximum of 48 hours prior to study drug start
Exclusion Criteria:
- Patients with ECOG 3-4 at study entry
Any of the following laboratory abnormalities:
- Absolute neutrophil count < 1.5 x 109/l or platelets < 75 x 109/l
- Serum creatinine > 2.0 mg/dl (177 mmol/l).
- Serum glutamic oxalacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) > 5,0 x upper limit of normal (ULN).
- Total bilirubin > 3 mg/dl.
- Known HIV infection or any other uncontrolled infection at study entry
- Known pleural effusion of any grade at study entry.
- Morphologic or cytogenetic or molecular relapse at study entry
- Evidence of digestive dysfunction that could prevent administration of study therapy
- Prior therapy with dasatinib during >21 days
- Other concurrent malignancy at study entry
- Uncontrolled or significant cardiovascular disease, including myocardial infarction within 6 months, uncontrolled angina within 3 months, prolonged QT interval, congestive heart failure within 3 months and clinically significant ventricular arrhythmias
- Any psychiatric condition that could prevent patient from signing the informed consent o could put the patient at an unacceptable risk in case of participating in the trial
- Subjects enrolled in another clinical trial at study entry. If patients have received other investigational agent, a minimum of 30 days wash-out period must have elapsed.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Dasatinib
|
Treatment with 100 mg QD of dasatinib (Sprycel®) administered orally as continuous daily dosing (CDD).
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
The efficacy of dasatinib
Tidsramme: at 2 years
|
The primary objective of this study is to assess the efficacy of dasatinib maintenance in terms of Disease Free Survival at 2 years in patients with Ph+ ALL who receive maintenance with dasatinib after allogeneic SCT.
|
at 2 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
To assess the efficacy of maintenance with dasatinib in terms of duration of hematologic, cytogenetic and molecular remission
Tidsramme: at 2 years
|
To assess the efficacy of maintenance with dasatinib in terms of duration of hematologic, cytogenetic and molecular remission, Relapse rate at 2 years, survival at 2 years, overall DFS, and Overall Survival (OS).
|
at 2 years
|
To assess the safety and tolerability of dasatinib maintenance regimen after allogeneic SCT
Tidsramme: at 2 years
|
To assess the safety and tolerability of dasatinib maintenance regimen after allogeneic SCT
|
at 2 years
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Guillermo Sanz, Doctor, Hospital La Fe de Valencia
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesykdommer
- Immunproliferative lidelser
- Leukemi
- Forløpercelle lymfoblastisk leukemi-lymfom
- Leukemi, lymfoid
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Proteinkinasehemmere
- Dasatinib
Andre studie-ID-numre
- DASA-TRAS
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Leukemi, lymfoblastisk, akutt, Philadelphia-positiv
-
Gruppo Italiano Malattie EMatologiche dell'AdultoAktiv, ikke rekrutterendeKronisk fase Philadelphia positiv | BCR-ABL Positiv | Kronisk myeloid leukemiItalia
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI); PfizerAvsluttetKronisk fase Kronisk myelogen leukemi, BCR-ABL1 positiv | Blasts Under 15 Percent of Bone Marrow Nucleated Cells | Blasts Under 15 Percent of Peripheral Blood White Cells | Blasts Under 30 Percent of Bone Marrow Nucleated Cells | Blasts Under 30 Percent of Peripheral Blood White CellsForente stater
-
Emory UniversityAvsluttetTilbakevendende kronisk myelogen leukemi, BCR-ABL1 positiv | Kronisk myelogen leukemi, BCR-ABL1 positivForente stater
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RekrutteringTilbakevendende kronisk myelogen leukemi, BCR-ABL1 positiv | Kronisk fase Kronisk myelogen leukemi, BCR-ABL1 positiv | Philadelphia kromosompositiv, BCR-ABL1 positiv kronisk myelogen leukemiForente stater
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeBlastfase kronisk myelogen leukemi, BCR-ABL1 positiv | Philadelphia kromosom positiv | Tilbakevendende akutt lymfatisk leukemi | Tilbakevendende kronisk myelogen leukemi, BCR-ABL1 positiv | Refraktær akutt lymfatisk leukemi | Refraktær kronisk myelogen leukemi, BCR-ABL1 positiv | t(9;22)Forente stater
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)FullførtPrimær myelofibrose | Trombocytopeni | Blastfase kronisk myelogen leukemi, BCR-ABL1 positiv | Kronisk fase Kronisk myelogen leukemi, BCR-ABL1 positiv | Akselerert fase kronisk myelogen leukemi, BCR-ABL1 positivForente stater
-
M.D. Anderson Cancer CenterAktiv, ikke rekrutterendeAkutt myeloid leukemi | Tilbakevendende akutt myeloid leukemi | Refraktær Akutt Myeloid Leukemi | Blastfase kronisk myelogen leukemi, BCR-ABL1 positiv | Tilbakevendende kronisk myelogen leukemi, BCR-ABL1 positiv | Refraktær kronisk myelogen leukemi, BCR-ABL1 positiv | Akselerert fase kronisk myelogen...Forente stater
-
M.D. Anderson Cancer CenterSchering-PloughAvsluttetLeukemi, Myeloid, Philadelphia-positivForente stater
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)FullførtBlastfase kronisk myelogen leukemi, BCR-ABL1 positiv | Tilbakevendende kronisk myelogen leukemi, BCR-ABL1 positiv | Refraktær kronisk myelogen leukemi, BCR-ABL1 positiv | Sprenger mer enn 5 prosent av benmargskjernede celler | B Akutt lymfatisk leukemi med t(9;22)(q34.1;q11.2); BCR-ABL1 | CD22... og andre forholdForente stater
-
Novartis PharmaceuticalsAvsluttet
Kliniske studier på dasatinib
-
Bristol-Myers SquibbFullførtFarmakokinetisk studie hos friske deltakereForente stater
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Fullført
-
Hyoung Jin KangHar ikke rekruttert ennåAkutt lymfatisk leukemi, pediatrisk
-
National Cancer Institute (NCI)NRG OncologyAvsluttetTilbakevendende egglederkarsinom | Tilbakevendende ovariekarsinom | Tilbakevendende primært peritonealt karsinom | Klarcellet ovariecystadenokarsinom | Endometrie klarcellet adenokarsinom | Tilbakevendende livmorkreftForente stater
-
Xspray Pharma ABQPS Bioserve India Pvt LimitedFullført
-
National Cancer Institute (NCI)TilbaketrukketHematopoetisk og lymfoid celle-neoplasma | Avansert lymfom | Avansert malignt solid neoplasma | Refraktær lymfom | Ildfast malignt fast neoplasma | Refraktært plasmacellemyelomForente stater
-
Jonsson Comprehensive Cancer CenterBristol-Myers SquibbFullført
-
Peking University Cancer Hospital & InstituteUkjentGastrointestinal stromal svulstKina
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)Fullført
-
Kanto CML Study GroupUkjentMyelogen leukemi, kronisk, kronisk faseJapan