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Trial Radar IA
Lo studio clinico NCT06742463 per Acute T Lymphpblastic Leukemia/Lymphoma è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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VHAG in Treating R/R T-ALL/LBL Fase II 50 Sopravvivenza globale

In arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT06742463 è uno studio interventistico di Fase II volto a esaminare il trattamento per Acute T Lymphpblastic Leukemia/Lymphoma, attualmente in arruolamento. Avviato il 1 dicembre 2024, prevede di arruolare 50 partecipanti. Sotto la guida di First Affiliated Hospital of Zhejiang University, dovrebbe concludersi entro il 30 giugno 2028. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 19 dicembre 2024.
Sommario breve
Acute T cell lymphoblastic leukemia/lymphoma (T-ALL/LBL) is an aggressive type of leukemia that results from the malignant evolution of T-lineage progenitor cells at different differentiation stages. After induction chemotherapy and consolidation chemotherapy, there are still about 30% of patients who cannot achieve complete remission of clinical symptoms or negative MRD. This is also an important factor for the recu...Mostra di più
Descrizione dettagliata
This is a prospective, single-arm, phase II and open-label study. A total of 50 R/R T-ALL/LBL participants will be enrolled. The primary endpoint is complete remission with or without peripheral blood cell recovery. The induction therapy is a combination of Venetoclax(Ven), Homoharringtonine(HHT) , Cytarabine and G-CSF. The purpose of this study is to explore efficacy of the VHAG in the treatment of R/R T-ALL/LBL pat...Mostra di più
Titolo ufficiale

Venetoclax Combined With HAG Regimen in Treating Adult Relapse/Refractory Acute T Cell Lymphoblastic Leukemia/Lymphoma: A Phase II, Single Arm and Multicenter Study

Patologie
Acute T Lymphpblastic Leukemia/Lymphoma
Pubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:
Altri ID dello studio
  • IIT20240113C
Numero NCT
NCT06742463
Data di inizio (effettiva)
2024-12
Ultimo aggiornamento pubblicato
2024-12-19
Data di completamento (stimata)
2028-06-30
Arruolamento (previsto)
50
Tipo di studio
Interventistico
FASE
Fase II
Stato
In arruolamento
Parole chiave
acute lymphoblastic leukemia
chemotherapy
relapse
refractory
Scopo principale
Trattamento
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleTreatment arm
Venetoclax for 4weeks(adjust according to BM on Day15), oral; Homoharringtonine for 1 week,iv; Cytarabine for 10-14 dsys, sc; G-CSF.
Venetoclax
BCL-2 inhibitor
homoharringtonine
alkaloid
Cytarabine (Ara-C)
Metabolic antagonist.
G-CSF
Granulocyte colony-stimulating factor
Esito primario
Misure di esitoDescrizione della misuraArco temporale
Complete remission with or without incomplete PB cell recovery(CR/CRi) rate
Blast rate lower than 5% with or without peripheral blood cell recovery
at the end of Cycle 1 and 2（each cycle is 28days）
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
Overall survival (OS)
Defined for all patients in a trial; measured from day 1 of treatment to the date of death from any cause;
up to 5 years
Event free survival(EFS)
Defined for all patients in a trial; measured from day 1 of treatment to the date of treatment failure, hematologic relapse from CR/CRi or death from any cause, whichever occurs first;
up to 2 years
Minimal residual disease (MRD)
MRD level detected by flow cytometry which value \<0.1% is defined as negtive
At the end of Cycle 1 and 2（each cycle is 28 days）
Adverse event
Safety of induction therapy
At the end of Cycle 1 and 2
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Bambino, Adulto, Adulto anziano
Età minima
14 Years
Sessi idonei
Tutti
  • 1. Before enrollment, a diagnosis of newly diagnosed T-cell acute leukemia/lymphoma.The diagnostic criteria refer to the 2022 WHO classification; 2. Age ≥ 14 years,<75 years; 3. Clincally diagnosed as relapsed or refractory T-ALL/LBL; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 5. Expected survival time ≥ 2 months; 6. No organ dysfunction that would restrict the use of this protocol during the screening period; 7. Understand the study and sign the informed consent form.

  • 1. Patients with known central nervous system (CNS) involvement of T-ALL/LBL; 2. Diseases with abnormal heart, lung, liver, kidney, or other organ functions that may limit the patient's participation in this trial (including but not limited to severe infections, uncontrolled diabetes, severe heart failure or angina, active pulmonary tuberculosis, asthma, COPD, bronchiectasis, etc.) 3. Cardiac ultrasound LVEF < 45%; 4. History of other malignancies within the past 5 years, excluding localized thyroid cancer and in situ skin cancer; 5. Serum total bilirubin > 1.5 ULN (upper limit of normal); ALT or AST > 2.5 ULN; serum creatinine > 1.5 ULN; 6. Known HIV infection; 7. Conditions affecting the use of the study drug as assessed by the investigator; 8. Inability to understand or comply with the study protocol.
First Affiliated Hospital of Zhejiang University logoFirst Affiliated Hospital of Zhejiang University
Contatti principali dello studio
Contatto: Jie Jin, M.D., +8657187236896, [email protected]
Contatto: Chenying Li, Ph.D., +8657187236896, [email protected]
1 Centri dello studio in 1 paesi

Zhejiang

The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310003, China
Jie Jin, M.D., Contatto, +86571-87236896, [email protected]
Jie Jin, M.D., Investigatore principale
In arruolamento