NCT07757672Toborzás még nem indult1/2. fázis
Salvage Chemotherapy With Sonrotoclax, Cladribine, and Standard-dose Cytarabine, Sequentially Followed by HSCT for R/R AML.
A Prospective Phase II Clinical Trial of Salvage Chemotherapy With Sonrotoclax, Cladribine, and Standard-dose Cytarabine, Sequentially Followed by Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed/Refractory Acute Myeloid Leukemia
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 11.
Rövid összefoglaló (regiszter, angolul)
The goal of this clinical trial is to treat adult patients with relapsed/refractory acute myeloid leukemia (AML) using a salvage chemotherapy regimen consisting of Sonrotoclax, cladribine, and standard-dose cytarabine, sequentially followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT). The main questions it aims to answer are: Does this treatment regimen improve the 2-year overall survival (OS) rate, relapse-free survival (RFS) rate, and cumulative incidence of relapse (CIR) in this patient population? What is the safety profile of this combination and sequential transplant strategy, particularly regarding treatment-related mortality (TRM) and adverse events? As this is a single-arm phase II study, there is no comparator group. Participants will: Receive salvage chemotherapy with cladribine (5 mg/m² on days 1-5), cytarabine (100 mg/m² twice daily on days 1-5), and Sonrotoclax (escalating doses from 40 mg to 320 mg on days 1-14). Undergo allogeneic hematopoietic stem cell transplantation as a bridge therapy within 1 to 4 weeks after completing chemotherapy. Potentially receive Sonrotoclax as maintenance therapy after hematopoietic reconstitution post-transplant, at the investigator's discretion. Undergo regular follow-up visits for clinical assessments, disease monitoring, and survival evaluation.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 1/2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 50 (tervezett)
- Első benyújtás
- 2026. jún. 30.
- Kezdés
- 2026. szept. 1.
- Elsődleges befejezés
- 2029. ápr. 30.
- Fő szponzor
- Institute of Hematology & Blood Diseases Hospital, China
- Betegségek
- Akut mieloid leukémia (AML)
- NCT-szám
- NCT07757672
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1/2. fázis
- Tervezett résztvevők: 50
- 2026. szept. 1. és az elsődleges befejezés (2029. ápr. 30.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- 5. Prior hematopoietic stem cell transplantation.
Más betegség
- 1. Uncontrolled active infection (bacterial, fungal, or viral).
- 2. Known positive serology for human immunodeficiency virus (HIV) or active hepatitis C virus (HCV).
- 3. Psychiatric disorders or other medical conditions that preclude compliance with the study treatment and monitoring requirements.
- 8. Any other condition that, in the investigator's opinion, makes the patient ineligible for study participation.
Laborértékek
- 6. Active cardiac disease, defined as one or more of the following: History of uncontrolled or symptomatic angina pectoris; Myocardial infarction within 6 months prior to study enrollment; History of arrhythmia requiring medication or clinically significant symptomatic arrhythmia; Uncontrolled or symptomatic congestive heart failure (> New York Heart Association [NYHA] class 2); Ejection fraction below the lower limit of normal; Previous coronary angioplasty or stent implantation.
- 7. Severe hepatic impairment, defined as liver function parameters (ALT, TBIL) > 3 × upper limit of normal (ULN); or severe renal impairment, defined as serum creatinine (Cr) > 2 × ULN, or 24-hour urine creatinine clearance < 50 mL/min; or any other condition that, in the investigator's opinion, renders the patient unsuitable for treatment with the study drug.
Egyéb
- 4. Pregnant patients, or patients who are unwilling or unable to use adequate contraceptive measures during the treatment period.
Kiket keres a vizsgálat
- 1.Patients with a confirmed diagnosis of relapsed or refractory acute myeloid leukemia (AML) based on bone marrow morphology, immunophenotyping, and cytogenetics.
- 2. Patients who are planned to undergo allogeneic hematopoietic stem cell transplantation, including HLA-matched or HLA-mismatched related allogeneic transplantation, as well as unrelated donor transplantation.
- 3. Age between 18 and 65 years, inclusive, regardless of gender.
- 4. Eastern Cooperative Oncology Group performance status (ECOG) of 0-2.
- 5. Written informed consent must be obtained prior to the initiation of any study-related procedures. For patients aged 18 years or older, the consent form may be signed by the patient or by a direct relative. Should the patient's own signature be judged to be potentially harmful to their clinical care, consent may instead be given by a legal guardian or a direct relative.
Életkor a regiszterben: 18 év – 65 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.