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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • BCL-2 inhibitors combined with the HyperCVAD regimen

    Drug

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

  • Propensity score matching historical data

    Other intervention

    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.

Treatment groups

206 Participants
are divided into 2 treatment groups
Group A: BCL-2 inhibitors combined with the HyperCVAD regimen for newly diagnosed T-ALL/LBLExperimental treatment 1 intervention
Group B: propensity score matching with historical dataOther 1 intervention

Trial outcomes

Primary outcomes

1

AE

adverse events during research

Time frame
at the end of cycle 2(each cycle is 28 days)
2

The best overall response rate

complete remission and partial remission

Time frame
at the end of cycle 2(each cycle is 28 days)
3

Evaluate the best complete remission rate (CR)

Time frame
at the end of cycle 4 of chemotherapy(each cycle is 28 days)

Secondary outcomes

1

Duration of remission

Duration of remission

Time frame
1 year
2

OS

1 year overall survival

Time frame
1 year
3

OS

2 year overall survival

Time frame
2 year
4

PFS

1 year progression free survival

Time frame
1 year

Other outcomes

Sponsors and contacts

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