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Die klinische Studie NCT06742463 für Acute T Lymphpblastic Leukemia/Lymphoma ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.
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VHAG in Treating R/R T-ALL/LBL Phase 2 50 Gesamtüberleben

Offene Rekrutierung
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Die klinische Studie NCT06742463 untersucht Behandlung im Zusammenhang mit Acute T Lymphpblastic Leukemia/Lymphoma. Diese interventionsstudie der Phase 2 hat den Status offene rekrutierung und startete am 1. Dezember 2024. Es ist geplant, 50 Teilnehmer aufzunehmen. Durchgeführt von First Affiliated Hospital of Zhejiang University wird der Abschluss für 30. Juni 2028 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 19. Dezember 2024 aktualisiert.
Kurzbeschreibung
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...Mehr anzeigen
Ausführliche Beschreibung
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...Mehr anzeigen
Offizieller Titel

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

Erkrankungen
Acute T Lymphpblastic Leukemia/Lymphoma
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • IIT20240113C
NCT-Nummer
NCT06742463
Studienbeginn (tatsächlich)
2024-12
Zuletzt aktualisiert
2024-12-19
Studienende (vorauss.)
2028-06-30
Geplante Rekrutierung
50
Studientyp
Interventionsstudie
PHASE
Phase 2
Status
Offene Rekrutierung
Stichwörter
acute lymphoblastic leukemia
chemotherapy
relapse
refractory
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellTreatment 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
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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）
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Kind, Erwachsene, Ältere Erwachsene
Mindestalter
14 Years
Zugelassene Geschlechter
Alle
  • 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
Zentrale Studienkontakte
Kontakt: Jie Jin, M.D., +8657187236896, [email protected]
Kontakt: Chenying Li, Ph.D., +8657187236896, [email protected]
1 Studienstandorte in 1 Ländern

Zhejiang

The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310003, China
Jie Jin, M.D., Kontakt, +86571-87236896, [email protected]
Jie Jin, M.D., Hauptprüfer
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