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AzTrials

T-cell Acute Lymphoblastic LeukemiaPhase 2NCT06686108

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

A Phase 2 study testing Azacitidine (AZA) Days 1 - 5, Decitabine (DAC) and Venetoclax in people with T-cell Acute Lymphoblastic Leukemia and ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION, 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

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)… Read more about this study

Who is it for?
Ages 14 to 55 years
What is being tested?
Azacitidine (AZA) Days 1 - 5, Decitabine (DAC) and Venetoclax
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteChina
Study dates
30 Oct 2024to 30 Oct 2028
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 14 to 55 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.
  • 5.One of the following high-risk factors:
  • a. Age of initial diagnosis ≥ 35 years old.
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  • b. Initial diagnosis of WBC ≥ 100 × 109/L.
  • c. Initial diagnosis of LDH exceeding the upper limit of normal values.
  • d. Initial diagnosis of bone marrow involvement (blast cells ≥ 5%).
  • e. Initial diagnosis of a bulky in the mediastinum (longest diameter ≥ 10cm).
  • f. ETP immunophenotype.
  • g. During the induction chemotherapy process, 2 courses did not achieve partial remission and/or 4 courses did not achieve complete remission.
  • h. Residual lesions before transplantation: Flow cytometry analysis showed that the proportion of abnormal lymphoid cells in the bone marrow was greater than 0.01%; Positive detection of minimal residual lesions in molecular biology; PET-CT scan shows that residual lesions are still active.
  • i. Based on the ELN recommendation based on adult T-ALL: gene mutations involving myeloid related genes, RAS/PI3K/AKT, JAK/STAT signaling pathway, and epigenetics, such as FLT3, NRAS/KRAS, PTEN, IL7R, JAK1, JAK3, DNMT3A, IDH1, IDH2; TP53, BCL2 mutations; t (8; 14) (q24; q11)/MYC rearrangement; t (7; 19) (q34; p13)/TCR-LYL1，TCR-MEF2C; del(5q) (q14).
  • j. High risk subgroups based on NGS definition: PI3K signaling pathway/NRAS, KRAS/TP53/IKZF1/DNTM3A/IDH1, IDH2 gene mutation with or without NOTCH1, FBXW7/PHF6/EP300 gene mutation.

Who cannot join

  • 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.
  • 5.Individuals who are known to be allergic to demethylating drugs or venetoclax.
  • 6.Individuals with grade 2 or more degrees of active acute GVHD.
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  • 7.Individuals with moderate to severe chronic GVHD.
  • 8.T-LBL/ALL relapse (flow cytometry abnormal lymphocyte cell proportion>0.01%, WT1 positive, fusion gene positive, or extramedullary recurrence), or transplant rejection, bone marrow donor cell chimerism<95%.
  • 9.Blood routine: ANC<1.0 × 109/L or PLT<50 × 109/L.
  • 10.Combined with severe organ dysfunction; The ratio of aspartate aminotransferase (AST)/alanine aminotransferase (ALT) is more than 3 times the normal value or the normal value of direct bilirubin is more than 3 times; The endogenous creatinine clearance rate (Ccr) is less than 50mL/min or 1.5 times the normal value of blood creatinine, regardless of whether hemodialysis treatment is used.
  • 11.Merge severe active infections.
  • 12.Pregnant or lactating women.
  • 13. Accepting other investigational drugs.
  • 14.According to the researchers' assessment, the patient may have complications that could lead to other dangers.

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 contact

+8613501672508

shongxm@139.com

China1 site, 1 recruiting

  • Shanghai General Hospital

    Shanghai

    Xianmin Song, +8613501672508, shongxm@139.com

    Recruiting

Other trials in China

About this study

Official title: Safety and Efficacy Study of Demethylating Agents With Venetoclax in Preventing Recurrence of High-risk T-cell Lymphoblastic Lymphoma/Leukemia After Transplantation

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.

Read the detailed description

The experimental group included high risk T-ALL/LBL patients after allo-HSCT, who received relapse prevention treatment with demethylating agents such as azacitidine or decitabine, combined with venetoclax.

The historical control consisted of high-risk T-ALL/LBL patients who received allo-HSCT but did not receive any prophylactic treatment from multiple centers, and their basic information, disease information, treatment details, and efficacy data were collected. Propensity score matching was conducted with historical data to compare the advantages and disadvantages of the experimental regimen with the control group.

The primary endpoint was the relapse-free survival(RFS) rate after prophylaxis, while secondary endpoints included cumulative incidence of relapse (CIR), overall survival (OS), and the GVHD-relapse-free survival (GRFS). This study aims to provide a effective and safer prophylaxis treatment for high-risk T-LBL/ALL patients after all-HSCT.

Being tested
Azacitidine (AZA) Days 1 - 5, Decitabine (DAC), Venetoclax
Keywords
T-cell lymphoblastic lymphoma/leukemia, relapse, allogeneic hematopoietic stem cell transplantation
Medical subject headings
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Recurrence, Leukemia

What participants receive

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

  • Azacitidine (AZA) Days 1 - 5Drug

    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.

  • VenetoclaxDrug

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

Study groups in NCT06686108
Study groupRoleWhat they receive
combination therapyExperimentalThere is only 1 arm. Combination therapy arm included venetoclax combined with hypomethylating agents such as azacitidine or decitabine. 1. venetoclax: 400mg/d, po, days 1-7 of each 28-day cycle. 2.For patients without TP53 mutation, azacitidine was administered: 32mg/m2/d, ih, days 1-5 of each 28-day cycle; for patients with TP53 mutation, decitabine was administered: 5mg/m2/d, iv, days 1-5 of each 28-day cycle.
Receives: Drug: Azacitidine (AZA) Days 1 - 5; Drug: Decitabine (DAC); Drug: Venetoclax

What is being measured

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

  1. RFS

    1-year relapse-free survival

    Measured: 1 year

  2. RFS

    2-year relapse-free survival

    Measured: 2 year

Secondary outcomes (9)

  1. CIR

    1-year cumulative incidence of relapse

    Measured: 1 year

  2. CIR

    2-year cumulative incidence of relapse

    Measured: 2 year

  3. OS

    1-year overall survival

    Measured: 1 year

  4. OS

    2-year overall survival

    Measured: 2 year

  5. GRFS

    1-year graft-versus-host disease (GVHD)-free/relapse-free survival (GRFS) rates

    Measured: 1 year

  6. GRFS

    2-year graft-versus-host disease (GVHD)-free/relapse-free survival (GRFS) rates

    Measured: 2 year

  7. cGVHD

    1-year cumulative incidence of cGVHD

    Measured: 1 year

  8. cGVHD

    2-year cumulative incidence of cGVHD

    Measured: 2 year

  9. adverse events

    adverse events during research

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

Timeline

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

  1. First posted13 Nov 2024
  2. Study start30 Oct 2024
  3. Primary completion30 Oct 2027 (estimated)
  4. Study completion30 Oct 2028 (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
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
59 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06686108
Sponsor's protocol ID
SHSYXY-T-LBL-AZA/VEN-Rel-2024
Status last verified
Oct 2024
First submitted
11 Nov 2024
Last updated
7 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Azacitidine (AZA) Days 1 - 5, Decitabine (DAC) and Venetoclax in people with T-cell Acute Lymphoblastic Leukemia and ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION, 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?

The sponsor lists 15 inclusion and 14 exclusion criteria. 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 7 May 2025. 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 (+8613501672508, shongxm@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RFS (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06686108.

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 7 May 2025.

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