Skip to content

Open-ended prospective clinical trial of skeleton scheme based on epigenetics in combination with DEL chemotherapy in relapsed/refractory children with acute T-lymphocyte leukemia (T-ALL) or T cell lymphoblastic lymphoma (T-NHL)

Open-ended prospective clinical trial of skeleton scheme based on epigenetics in combination with DEL chemotherapy in relapsed/refractory children with acute T-lymphocyte leukemia (T-ALL) or T cell lymphoblastic lymphoma (T-NHL)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058721
Enrollment
Unknown
Registered
2022-04-15
Start date
2022-04-30
Completion date
Unknown
Last updated
2024-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute T-lymphocyte leukemia or T cell lymphoblastic lymphoma

Interventions

treatment group 1:Chidamide + HMAs + Venetoclax+Dex+VP16+Peg-Asp

Sponsors

Children's Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. The age of first visit is 0-18 years, male and female; 2. Children with acute T-lymphocyte leukemia (T-ALL) or T cell lymphoblastic lymphoma (T-NHL) confirmed by pathology (2008 WHO classification of hematopoiesis and lymphoid tissue tumors); . 3. Patients who had relapsed after at least one previous systemic therapy failure (refractory) or remission (including extramedullary relapse); 4. ECOG status scores were 0-3; 5. Life expectancy =3 months; 6. No serious heart, lung, liver or Kidney Diseases; 7. Capable of understanding and willing to sign this informed consent form. And has a full understanding of the purpose and significance of this test, and is willing to comply with the test program.

Exclusion criteria

Exclusion criteria: 1. Children with other tumors; 2. Children with severe concomitant disease, children with Severe Resistance to chemotherapy regimens (multiple malformations, heart disease, metabolic disorders, etc.); 3. Children with a history of mental illness that may prevent them from completing treatment; 4. Children with allergies to drugs or the same compounds in the combination regimens; 5. Children judged unfit to participate in the trial.

Design outcomes

Primary

MeasureTime frame
complete remission;partial remission;Minimal residual disease;

Secondary

MeasureTime frame
event-free-survival;relapse-free-survival;overall survival;complete remission with incomplete bloodcount recovery;

Countries

China

Contacts

Public ContactHu Shaoyan

Children's Hospital of Soochow University

hushaoyan@suda.edu.cn+86 512 80692929

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026