beta
Trial Radar IA
Lo studio clinico NCT07105579 per Leucemia, Recidiva 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.
Un studio corrisponde ai criteri del filtro
Vista a schede
Torna alla ricerca

Effectiveness and Safety of Blinatumomab and Donor Lymphocyte Infusion in Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for High-risk Ph Negative B Cell Acute Lymphoblastic Leukemia Fase II 31

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 NCT07105579 è uno studio interventistico di Fase II volto a esaminare la prevenzione per Leucemia, Recidiva, attualmente in arruolamento. Avviato il 1 agosto 2025, prevede di arruolare 31 partecipanti. Sotto la guida di First Affiliated Hospital of Zhejiang University, dovrebbe concludersi entro il 31 dicembre 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 6 agosto 2025.
Sommario breve
A single-arm trial to evaluate the effectiveness and safety of Blinatumomab and Donor Lymphocyte Infusion in maintenance therapy after allogeneic hematopoietic stem cell transplantation for high-risk Ph negative B cell acute lymphoblastic leukemia
Descrizione dettagliata
Currently, the treatment for Philadelphia chromosome (Ph)-negative adult B-cell acute lymphoblastic leukemia (B-ALL) primarily relies on traditional multi-agent combination chemotherapy. Clinical efficacy is closely associated with patient age, genetic characteristics, chemotherapy sensitivity, and minimal residual disease (MRD) status post-remission. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) rem...Mostra di più
Titolo ufficiale

Effectiveness and Safety of Blinatumomab and Donor Lymphocyte Infusion in Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for High-risk Ph Negative B Cell Acute Lymphoblastic Leukemia：Phrase II, Exploratory Study

Patologie
LeucemiaRecidiva
Altri ID dello studio
  • ZJU-HSCT-BITEDLI
Numero NCT
NCT07105579
Data di inizio (effettiva)
2025-08
Ultimo aggiornamento pubblicato
2025-08-06
Data di completamento (stimata)
2027-12-31
Arruolamento (previsto)
31
Tipo di studio
Interventistico
FASE
Fase II
Stato
In arruolamento
Parole chiave
hematopoietic stem cell transplantation
Blinatumomab
Donor Lymphocyte Infusion
Ph negative B cell Acute Lymphoblastic Leukemia
Scopo principale
Prevenzione
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleBlinatumomab and Donor Lymphocyte Infusion
BITE and DLI
Blinatumomab dosage: Cycle 1 (starting at day 60 post-transplant):Days 1-3: 9 μg/day，Days 4-14: 28 μg/day Cycles 2-4:Days 1-14: 28 μg/day Administration method: Continuous 24-hour intravenous infusion, one cycle every 3 months. DLI eligibility criteria:No history of grade III-IV acute GVHD (aGVHD).No active aGVHD or chronic GVHD (cGVHD) at the time of infusion DLI dosage:Administered at day 120 post-HSCT, CD3+ cel...Mostra di più
Esito primario
Misure di esitoDescrizione della misuraArco temporale
The 2-year leukemia-free survival (LFS) after allo-HSCT.
2 years
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
The 2-year overall survival（OS）
2-year overall survival from transplant
2 years
The 2-year cumulative incidence of relapse
2-years
The 2-year cumulative incidence of non-relapse mortality(NRM)
2-years
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Bambino, Adulto, Adulto anziano
Età minima
14 Years
Sessi idonei
Tutti
  1. Age 14-65 years (inclusive), regardless of gender.
  2. Newly diagnosed B-ALL with CD19 expression on leukemic cells (regardless of CD19 positivity rate).
  3. Ph-negative B-ALL with high-risk features post-allo-HSCT .
  4. ≥2 months post-transplant with hematopoietic reconstitution.
  5. Bone marrow morphology in remission and MRD-negative before enrollment.
  6. ECOG performance status <3 and Karnofsky score ≥70.
  7. No history of grade III/IV graft-versus-host disease (GVHD) and no active GVHD at enrollment.
  8. Adequate organ function:AST and ALT ≤3× upper limit of normal (ULN), total bilirubin ≤2×ULN.Serum creatinine ≤2×ULN or creatinine clearance ≥50 mL/min (calculated by Cockcroft-Gault formula).Left ventricular ejection fraction (LVEF) ≥50% by echocardiography (ECHO).
  9. Expected survival >3 months.
  10. Voluntary provision of written informed consent, with ability to understand and comply with study requirements.

  1. History of hypersensitivity or severe adverse reactions to the study drug or structurally similar compounds, as assessed by the investigator to preclude participation.
  2. Pregnant or lactating women, or women of childbearing potential unwilling to use effective contraception.
  3. Severe cardiac dysfunction, including:Left ventricular ejection fraction (EF) <60%.Clinically significant arrhythmias (e.g., ventricular tachycardia, atrial fibrillation, second-degree heart block).Prolonged QTc interval (men >450 ms; women >470 ms).Myocardial infarction within the past year.Symptomatic coronary artery disease requiring medication.
  4. Severe pulmonary dysfunction (obstructive and/or restrictive ventilatory impairment).
  5. Severe hepatic impairment:ALT or total bilirubin (TBIL) >3× upper limit of normal (ULN).
  6. Severe renal impairment:Serum creatinine (Cr) >2× ULN.24-hour creatinine clearance (Ccr) <50 mL/min.
  7. Active infection or uncontrolled bleeding, as assessed by the investigator to preclude safe administration of the study drug.
  8. History of thrombosis, embolism, cerebral hemorrhage, or other significant vascular events within the past year.
  9. Psychiatric disorders or other conditions that impair the ability to provide informed consent or comply with study procedures.
  10. Major organ surgery within the past six weeks.
  11. Drug abuse or chronic alcoholism that may interfere with study assessments.
  12. Prior organ transplantation (excluding hematopoietic stem cell transplantation).
  13. Other conditions deemed by the investigator to make the patient unsuitable for participation.
First Affiliated Hospital of Zhejiang University logoFirst Affiliated Hospital of Zhejiang University
Contatti principali dello studio
Contatto: Yi Luo, MD, 86-13666609126, [email protected]
Contatto: Luxin Yang, MD, 86-13588756650, [email protected]
1 Centri dello studio in 1 paesi
First Affiliated Hospital of Zhejiang University, Hangzhou, China
In arruolamento