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Lymphoblastic Lymphoma, AdultPhase 2NCT06598722

BCL-2 Inhibitors Combined with the HyperCVAD Regimen for Newly Diagnosed T-lymphoblastic Leukemia/lymphoma.

A Phase 2 study testing BCL-2 inhibitors combined with the HyperCVAD regimen and Propensity score matching historical data in people with Lymphoblastic Lymphoma, Adult and Lymphoblastic Leukemia, Acute T-cell, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The experimental group included patients diagnosed with T-ALL/LBL (T-lymphoblastic leukemia/ lymphoma) at initial diagnosis, who received treatment with BCL-2 inhibitors combined with the Hyper CVAD regimen. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
BCL-2 inhibitors combined with the HyperCVAD regimen and Propensity score matching historical data
Could I receive a placebo?
No, everyone receives an active treatment
How many people
206 participants
Where
1 siteChina
Study dates
7 Aug 2024to 7 Aug 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Inclusion Criteria Age 18-60 years, regardless of gender; Expected survival time greater than 12 weeks; ECOG score 0-2; Pathologically or flow cytometrically confirmed as T-cell lymphoblastic lymphoma, with less than 25% tumor cell proportion in bone marrow smears;

Liver and kidney function, as well as cardiopulmonary function, meet the following requirements:

Creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 mL/min; Left ventricular ejection fraction greater than 50%, with no clinically significant ECG changes; Baseline oxygen saturation greater than 92% Total bilirubin ≤1.5×ULN; ALT and AST ≤3×ULN Able to understand the trial and has signed the informed consent form Exclusion Criteria A history of acute T-cell leukemia, T-cell lymphoma, or T-cell lymphoblastic lymphoma within the past 5 years, except for adequately treated carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, or thyroid cancer after radical surgery Active bacterial, viral, or fungal infections that require treatment and are not controlled; those who are HBsAg or HBcAb positive, with peripheral blood HBV DNA ≥ the lower limit of detection; individuals who are positive for hepatitis C virus antibodies and have positive peripheral blood HCV RNA; individuals who test positive for syphilis (TRUST test); individuals who are positive for human immunodeficiency virus (HIV) antibodies Dysfunction of important organs (cardiovascular, pulmonary) or a history of active gastrointestinal bleeding within the past 3 months; individuals with uncontrolled hypertension, hypertensive crisis, or a history of hypertensive encephalopathy, and a history or evidence of significant cardiovascular risk, including any of the following: congestive heart failure, unstable angina, clinically significant arrhythmias (e.g., ventricular fibrillation, ventricular tachycardia); a history of arterial thrombosis within the past 3 months (e.g., stroke, transient ischemic attack); a history of symptomatic deep vein thrombosis, pulmonary embolism within the past 6 months, or a history of coronary angioplasty, defibrillation, or any clinical complications or diseases that may pose a risk to the participant\'s safety or interfere with the evaluation, procedures, or completion of the study Any uncontrolled active disease that may interfere with participation in the trial; Active, uncontrolled central nervous system diseases or a history of central nervous system disease requiring treatment (e.g., epilepsy) Pregnant or breastfeeding women; and individuals planning to become pregnant within 1 year after infusion, during treatment, or after treatment ends Presence of uncontrolled active infections (except for simple urinary tract infections or upper respiratory infections Known allergies to any components of cyclophosphamide, doxorubicin, vincristine, cytarabine, methotrexate, etc.

Any situation that the investigator believes would compromise participant safety or interfere with the study objectives, or any individual deemed inappropriate for participation by the investigator Individuals with diseases affecting their ability to sign the written informed consent form or comply with study procedures; those unwilling or unable to adhere to study requirements

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xianmin Song,MD contact

+8613501672508

shongxm@139.com

China1 site, 1 recruiting
  • Shanghai General Hospital

    Shanghai

    Recruiting

Other trials in China

About this study

Official title: The Efficacy and Safety of BCL-2 Inhibitors Combined with the HyperCVAD Regimen in the Treatment of Newly Diagnosed T-lymphoblastic Leukemia/ Lymphoma

The experimental group included patients diagnosed with T-ALL/LBL (T-lymphoblastic leukemia/ lymphoma) at initial diagnosis, who received treatment with BCL-2 inhibitors combined with the Hyper CVAD regimen. The control group consisted of patients diagnosed with T-ALL/LBL from multiple centers, for whom basic information, disease information, treatment details, and efficacy data were collected. Propensity score matching was conducted with historical data (matching factors included age, gender, initial LDH levels, and the presence or absence of a large mediastinal mass at diagnosis) to compare the advantages and disadvantages of the experimental regimen with previous induction treatment protocols. The primary endpoint was the complete remission (CR) rate after induction chemotherapy, while secondary endpoints included duration of remission (DOR), progression-free survival (PFS), overall survival (OS), and the occurrence of adverse events. This study aims to provide a more effective and safer treatment option for patients with T-LBL.

Being tested
BCL-2 inhibitors combined with the HyperCVAD regimen, Propensity score matching historical data
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BCL-2 inhibitors combined with the HyperCVAD regimenDrug

    BCL-2 inhibitors combined with the HyperCVAD regimen for newly diagnosed adult T-ALL/LBL

  • Propensity score matching historical dataOther

    Propensity score matching was conducted with historical data (matching factors included age, gender, initial LDH levels, and the presence or absence of a large mediastinal mass at diagnosis) to compare the advantages and disadvantages of the experimental regimen with previous induction treatment protocols.

Study groups in NCT06598722
Study groupRoleWhat they receive
BCL-2 inhibitors combined with the HyperCVAD regimen for newly diagnosed T-ALL/LBLExperimentalNot described
Receives: Drug: BCL-2 inhibitors combined with the HyperCVAD regimen
propensity score matching with historical dataOtherNot described
Receives: Other: Propensity score matching historical data

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AE

    adverse events during research

    Measured: at the end of cycle 2(each cycle is 28 days)

  2. The best overall response rate

    complete remission and partial remission

    Measured: at the end of cycle 2(each cycle is 28 days)

  3. Evaluate the best complete remission rate (CR)

    Measured: at the end of cycle 4 of chemotherapy(each cycle is 28 days)

Secondary outcomes (6)
  1. Duration of remission

    Duration of remission

    Measured: 1 year

  2. OS

    1 year overall survival

    Measured: 1 year

  3. OS

    2 year overall survival

    Measured: 2 year

  4. PFS

    1 year progression free survival

    Measured: 1 year

  5. PFS

    2 year progression free survival

    Measured: 2 year

  6. the proportion of successful bridging to allogeneic hematopoietic stem cell transplantation

    he proportion of successful bridging to allogeneic hematopoietic stem cell transplantation

    Measured: the end of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start7 Aug 2024
  3. Primary completion7 Aug 2026 (estimated)
  4. Study completion7 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
206 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06598722
Sponsor's protocol ID
SHSYXY-T-LBL-VEN-2024
Status last verified
Sep 2024
First submitted
3 Sep 2024
Last updated
24 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BCL-2 inhibitors combined with the HyperCVAD regimen and Propensity score matching historical data in people with Lymphoblastic Lymphoma, Adult and Lymphoblastic Leukemia, Acute T-cell, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xianmin Song,MD (+8613501672508, shongxm@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AE (time frame: at the end of cycle 2(each cycle is 28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.

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