A Phase 2 interventional study of Venetoclax and homoharringtonine in Acute T Lymphpblastic Leukemia/Lymphoma, sponsored by First Affiliated Hospital of Zhejiang University. Recruiting at 1 site in China. Open to participants aged 14 Years to 74 Years. Per ClinicalTrials.gov, last updated 2024-12-19.
Sponsored by First Affiliated Hospital of Zhejiang University · Phase 2, Interventional, and Treatment
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 recurrence of ALL patients. In addition, most relapsed T-ALL/LBL patients relapse during first-line treatment. Once the disease relapses, it is difficult to cure for most young and adult patients, and the overall survival rate of patients is less than 10%.
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 patients.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 50 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →First Affiliated Hospital of Zhejiang University is the lead sponsor of 255 studies on the registry; 139 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Venetoclax for 4weeks(adjust according to BM on Day15), oral; Homoharringtonine for 1 week,iv; Cytarabine for 10-14 dsys, sc; G-CSF.
Drug: Venetoclax · Drug: homoharringtonine · Drug: Cytarabine (Ara-C) · Drug: G-CSF
BCL-2 inhibitor
alkaloid
Metabolic antagonist.
Granulocyte colony-stimulating factor
Complete remission with or without incomplete PB cell recovery(CR/CRi) rate
Blast rate lower than 5% with or without peripheral blood cell recovery
Time frame: at the end of Cycle 1 and 2（each cycle is 28days）
Overall survival (OS)
Defined for all patients in a trial; measured from day 1 of treatment to the date of death from any cause;
Time frame: 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;
Time frame: up to 2 years
Minimal residual disease (MRD)
MRD level detected by flow cytometry which value \<0.1% is defined as negtive
Time frame: At the end of Cycle 1 and 2（each cycle is 28 days）
Adverse event
Safety of induction therapy
Time frame: At the end of Cycle 1 and 2
Plan to share: No
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First Affiliated Hospital of Zhejiang University