Health TrialsbyHealthPanel

Demethylating Agents Combined With Venetoclax for High-risk T-cell Lymphoblastic Lymphoma/Leukemia Post-Transplant Relapse Prevention

ConditionsT-cell Acute Lymphoblastic LeukemiaALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATIONRelapse
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14-55
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

This study is a prospective, phase II clinical trial with the primary objective of assessing the effectiveness of demethylating agents combined with venetoclax in the prevention of recurrence after allogeneic hematopoietic stem cell transplantation (allo-HSCT) of high risk T-lymphoblastic lymphoma/leukemia (T-LBL/ALL) patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1.14-55 years old, male,or female.

2.Patients with allo-HSCT due to T-LBL/ALL, the donor type is not limited.

3.ECOG score is 0-2 points.

4.Blood routine: ANC ≥ 1.0 × 109/L, PLT ≥ 50 × 109/L.

Disqualifiers

1.Central involvement during any course of the disease.

2.Patients who have not achieved complete remission before transplantation.

3.Identify those with available targeted drugs.

4.For those who are resistant to BCL-2 inhibitors before transplantation, if the disease progresses during the application process, or if 3-4 courses of induction therapy containing BCL2 inhibitors do not improve.

Trial design

Design model

Single group

Treatments tested in this trial

  • Azacitidine (AZA) Days 1 - 5

    Drug

    Azacitidine, ih, 32mg/m2/d, days 1-5 of each 28-day cycle

  • Decitabine (DAC)

    Drug

    decitabine, 5mg/m2/d, days 1-5 of each 28-day cycle.

  • Venetoclax

    Drug

    venetoclax, 400mg/d, days 1-7 of each 28-day cycle

Treatment groups

59 Participants
are divided into 1 treatment group
Group A: combination therapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

RFS

1-year relapse-free survival

Time frame
1 year
2

RFS

2-year relapse-free survival

Time frame
2 year

Secondary outcomes

1

CIR

1-year cumulative incidence of relapse

Time frame
1 year
2

CIR

2-year cumulative incidence of relapse

Time frame
2 year
3

OS

1-year overall survival

Time frame
1 year
4

OS

2-year overall survival

Time frame
2 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Lead sponsor

Source ClinicalTrials.gov
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