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Prevention study for T-cell Acute Lymphoblastic Leukemia
Official title Demethylating Agents Combined With Venetoclax for High-risk T-cell Lymphoblastic Lymphoma/Leukemia Post-Transplant Relapse Prevention
ClinicalTrials.gov ID: NCT06686108
What this study is testing
What is Azacitidine (AZA) Days 1 - 5?
Azacitidine (AZA) Days 1 - 5 is an investigational medicine, being studied as a potential treatment for t-cell acute lymphoblastic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 55
You may be able to join if
- 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:
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- 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.
- 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...
- 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...
- 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.
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.