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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 Phase 2 31

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Die klinische Studie NCT07105579 untersucht Prävention im Zusammenhang mit Leukämie, Rückfall. Diese interventionsstudie der Phase 2 hat den Status offene rekrutierung und startete am 1. August 2025. Es ist geplant, 31 Teilnehmer aufzunehmen. Durchgeführt von First Affiliated Hospital of Zhejiang University wird der Abschluss für 31. Dezember 2027 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 6. August 2025 aktualisiert.
Kurzbeschreibung
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
Ausführliche Beschreibung
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...Mehr anzeigen
Offizieller Titel

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

Erkrankungen
LeukämieRückfall
Weitere Studien-IDs
  • ZJU-HSCT-BITEDLI
NCT-Nummer
NCT07105579
Studienbeginn (tatsächlich)
2025-08
Zuletzt aktualisiert
2025-08-06
Studienende (vorauss.)
2027-12-31
Geplante Rekrutierung
31
Studientyp
Interventionsstudie
PHASE
Phase 2
Status
Offene Rekrutierung
Stichwörter
hematopoietic stem cell transplantation
Blinatumomab
Donor Lymphocyte Infusion
Ph negative B cell Acute Lymphoblastic Leukemia
Primäres Ziel
Prävention
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellBlinatumomab 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...Mehr anzeigen
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
The 2-year leukemia-free survival (LFS) after allo-HSCT.
2 years
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Kind, Erwachsene, Ältere Erwachsene
Mindestalter
14 Years
Zugelassene Geschlechter
Alle
  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
Zentrale Studienkontakte
Kontakt: Yi Luo, MD, 86-13666609126, [email protected]
Kontakt: Luxin Yang, MD, 86-13588756650, [email protected]
1 Studienstandorte in 1 Ländern
First Affiliated Hospital of Zhejiang University, Hangzhou, China
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