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NCT Number: NCT06742463

VHAG in Treating R/R T-ALL/LBL

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%.

Recruiting

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Key information

Age range

14 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location status: Recruiting

Location contact

Jie Jin, M.D.

CONTACT

[email protected]

+86571-87236896

Jie Jin, M.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

Venetoclax

Drug

BCL-2 inhibitor

Homoharringtonine

Drug

alkaloid

Cytarabine (ARA-C)

Drug

Metabolic antagonist.

G-CSF

Drug

Granulocyte colony-stimulating factor

Primary outcomes

  1. Complete remission with or without incomplete PB cell recovery(CR/CRi) rate

    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

Secondary outcomes

  1. Overall survival (OS)

    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;

  2. Event free survival(EFS)

    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;

  3. Minimal residual disease (MRD)

    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

  4. Adverse event

    Time frame: At the end of Cycle 1 and 2

    Safety of induction therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Chenying Li, Ph.D.

CONTACT

[email protected]

+8657187236896

Jie Jin, M.D.

CONTACT

[email protected]

+8657187236896

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Dec 19, 2024
Registry last updated
Dec 19, 2024

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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