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Die klinische Studie NCT06361329 für ETP-ALL ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in Newly Diagnosed ETP-ALL Phase 3 81
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Die klinische Studie NCT06361329 untersucht Behandlung im Zusammenhang mit ETP-ALL. Diese interventionsstudie der Phase 3 hat den Status offene rekrutierung und startete am 3. April 2024. Es ist geplant, 81 Teilnehmer aufzunehmen. Durchgeführt von First Affiliated Hospital of Zhejiang University wird der Abschluss für 31. März 2027 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 17. Februar 2025 aktualisiert.
Kurzbeschreibung
ETP-ALL is a subtype of T-cell acute lymphoblastic leukemia (T-ALL) with poor outcomes and prognosis. Effective induction therapy is crucial in improving the treatment effect. Based on our laboratory research and clinical practice, the venetoclax plus HAG regimen shows promising efficacy in treating ETP-ALL. Therefore, we plan to conduct a prospective, multicenter Phase III clinical study to evaluate the efficacy of ...Mehr anzeigen
Offizieller Titel
A Multicenter, Prospective, Randomized Controlled Clinical Study Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in the Treatment of Adult Newly Diagnosed Early Precursor T-cell Acute Lymphoblastic Leukemia (ETP-ALL)
Erkrankungen
ETP-ALLWeitere Studien-IDs
- 20240030C
NCT-Nummer
Studienbeginn (tatsächlich)
2024-04-03
Zuletzt aktualisiert
2025-02-17
Studienende (vorauss.)
2027-03-31
Geplante Rekrutierung
81
Studientyp
Interventionsstudie
PHASE
Phase 3
Status
Offene Rekrutierung
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellVHAG group Venetoclax: 100mg on day 1, 200mg on day 2, and 400mg on days 3-14, if the blast cells in bone marrow were more than 5% on day 14, the patient continued to receive venetoclax 400mg until day 28.
HHT:1.4 mg/m2,2mg maximum daily, intravenously daily from on d1-7 Cytarabine :10 mg/m2 subcutaneously every 12h on d1-14（d10-d14） G-CSF: 100ug/m2 daily on d1-14 if WBC count \<10\*10E9/L | Homoharringtonine Intravenous infusion venetoclax Orally by mouth Cytarabine subcutaneous injection or Intravenous infusion G-CSF subcutaneous injection |
Aktives VergleichspräparatTraditional Chemotherapy Regimen group * VDCLP regimen
* VD(/I) CP regimen
* Hyper CVAD-A regimen
* VDLP regimen | Cytarabine subcutaneous injection or Intravenous infusion Vindesine Intravenous infusion Daunorubicin Intravenous infusion cyclophosphamide Intravenous infusion Dexamethasone Intravenous infusion or orally L-ASP subcutaneous injection |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
1-year EFS | 1-year event free survival rate | 1 year |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
CR/CRi | Complete remission/complete remission with incomplete count recovery | At the end of Cycle 1 (up to 42 days) |
OS | Overall survival | through study completion, up to 3 years |
MRD | Percentage of participants who converted to MRD \< 10\^-3 after the first cycle of treatment. | At the end of Cycle 1 (up to 42 days) |
Safety of induction therapy | Adverse events | At the end of Cycle 1 (up to 42 days) |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind, Erwachsene, Ältere Erwachsene
Mindestalter
14 Years
Zugelassene Geschlechter
Alle
- Age ≥14 and <75 years old.
- Diagnosed with ETP-ALL (including near-ETP ALL) before enrollment.
- Newly diagnosed patients.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Expected survival of ≥3 months.
- Able to undergo oral treatment with venetoclax.
- No organ dysfunction that would restrict the treatment administered
- Understanding of the study and signing of the informed consent form.
- Men, women of childbearing potential (postmenopausal women must have been amenorrheic for at least 12 months to be considered infertile), and their partners must voluntarily use effective contraception methods as deemed appropriate by the investigator during the treatment period and for at least 12 months after the last dose of the study drug.
- Patients who are unable to take venetoclax by mouth;
- Patients with severe heart, lung, liver, kidney, or other organ dysfunction that may restrict their participation in this trial due to diseases;
- Evidence of other clinically significant uncontrolled condition(s) such as uncontrolled and/or active systemic infection (viral, bacterial or fungal)
- A history of other malignant tumors within the past 5 years, excluding localized thyroid cancer and in situ skin cancer;
- Serum total bilirubin >1.5 ULN (upper limit of normal) (excluding leukemia infiltration); ALT or AST or ALP >5 ULN; serum creatinine >1.5 ULN and creatinine clearance rate <40 mL/min; LVEF <50%;
- Known HIV infection;
- Known central nervous system leukemia infiltration;
- Gastrointestinal diseases known to affect venetoclax absorption as judged by the investigator;
- Inability to understand or comply with the study protocol.
First Affiliated Hospital of Zhejiang UniversityKeine Kontaktdaten vorhanden
1 Studienstandorte in 1 Ländern
Zhejiang
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310003, China
Jie Jin, PhD&MD, Kontakt, 13705716779, [email protected]
Offene Rekrutierung