VHAG in Treating R/R T-ALL/LBL

Phase 2

Recruiting

• Conditions: Acute T Lymphpblastic Leukemia/Lymphoma
• Interventions: Drug: Venetoclax; Drug: homoharringtonine; Drug: Cytarabine (Ara-C); Drug: G-CSF

• Registration Number: NCT06742463
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

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...

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 explor...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-12
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Last Update Submitted: 2024-12-16
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-19
• Primary Completion: 2026-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment arm	Venetoclax	Venetoclax for 4weeks(adjust according to BM on Day15), oral; Homoharringtonine for 1 week,iv; Cytarabine for 10-14 dsys, sc; G-CSF.
Treatment arm	homoharringtonine	Venetoclax for 4weeks(adjust according to BM on Day15), oral; Homoharringtonine for 1 week,iv; Cytarabine for 10-14 dsys, sc; G-CSF.
Treatment arm	Cytarabine (Ara-C)	Venetoclax for 4weeks(adjust according to BM on Day15), oral; Homoharringtonine for 1 week,iv; Cytarabine for 10-14 dsys, sc; G-CSF.
Treatment arm	G-CSF	Venetoclax for 4weeks(adjust according to BM on Day15), oral; Homoharringtonine for 1 week,iv; Cytarabine for 10-14 dsys, sc; G-CSF.

Primary Outcome Measures

Name	Time	Method
Complete remission with or without incomplete PB cell recovery(CR/CRi) rate	at the end of Cycle 1 and 2（each cycle is 28days）	Blast rate lower than 5% with or without peripheral blood cell recovery

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	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;
Event free survival(EFS)	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;
Minimal residual disease (MRD)	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
Adverse event	At the end of Cycle 1 and 2	Safety of induction therapy

Trial Locations

Locations (1)

The First Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China