The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
Location status: Recruiting
NCT Number: NCT06742463
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%.
Interested in participating?
Request Info14 year–74 year
All sexes
Interventional
Phase 2
Hangzhou, Zhejiang, 310003, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
BCL-2 inhibitor
alkaloid
Metabolic antagonist.
Granulocyte colony-stimulating factor
Time frame: at the end of Cycle 1 and 2(each cycle is 28days)
Blast rate lower than 5% with or without peripheral blood cell recovery
Time frame: up to 5 years
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 2 years
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: At the end of Cycle 1 and 2(each cycle is 28 days)
MRD level detected by flow cytometry which value <0.1% is defined as negtive
Time frame: At the end of Cycle 1 and 2
Safety of induction therapy
Contact information is provided by the study sponsor or research team.
Chenying Li, Ph.D.
CONTACT
Jie Jin, M.D.
CONTACT
First Affiliated Hospital of Zhejiang University
Other
Venetoclax Combined With HAG Regimen in Treating Adult Relapse/Refractory Acute T Cell Lymphoblastic Leukemia/Lymphoma: A Phase II, Single Arm and Multicenter Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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