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Clinical Trial NCT06742463 for Acute T Lymphpblastic Leukemia/Lymphoma is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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VHAG in Treating R/R T-ALL/LBL Phase 2 50 Overall Survival
Clinical Trial NCT06742463 is designed to study Treatment for Acute T Lymphpblastic Leukemia/Lymphoma. It is a Phase 2 interventional study that is recruiting, having started on December 1, 2024, with plans to enroll 50 participants. Led by First Affiliated Hospital of Zhejiang University, it is expected to complete by June 30, 2028. The latest data from ClinicalTrials.gov was last updated on December 19, 2024.
Brief Summary
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...Show More
Detailed Description
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...Show More
Official Title
Venetoclax Combined With HAG Regimen in Treating Adult Relapse/Refractory Acute T Cell Lymphoblastic Leukemia/Lymphoma: A Phase II, Single Arm and Multicenter Study
Conditions
Acute T Lymphpblastic Leukemia/LymphomaPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- IIT20240113C
NCT ID Number
Start Date (Actual)
2024-12
Last Update Posted
2024-12-19
Completion Date (Estimated)
2028-06-30
Enrollment (Estimated)
50
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
acute lymphoblastic leukemia
chemotherapy
relapse
refractory
chemotherapy
relapse
refractory
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalTreatment 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 |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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） |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Minimum Age
14 Years
Eligible Sexes
All
- 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 UniversityStudy Central Contact
Contact: Jie Jin, M.D., +8657187236896, [email protected]
Contact: Chenying Li, Ph.D., +8657187236896, [email protected]
1 Study Locations in 1 Countries
Zhejiang
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310003, China
Jie Jin, M.D., Contact, +86571-87236896, [email protected]
Jie Jin, M.D., Principal Investigator
Recruiting