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Maintenance therapy with Chidamide in patients with newly developed peripheral T-cell lymphoma after sequential autologous hematopoietic stem cell transplantation with Chidamide combined with BeMit chemotherapy

Maintenance therapy with Chidamide in patients with newly developed peripheral T-cell lymphoma after sequential autologous hematopoietic stem cell transplantation with Chidamide combined with BeMit chemotherapy

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200060408
Enrollment
Unknown
Registered
2022-05-31
Start date
2022-06-10
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

newly developed peripheral T-cell lymphoma

Interventions

Experimental group:Maintenance therapy with Chidamide and BeMit regimen after sequential autologous stem cell transplantation

Sponsors

Chongqing University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged above 18 years, no gender limit; 2. PTCL confirmed by histopathology falls into one of the following subtypes according to the WHO classification standard revised in 2016: (1) Peripheral T-cell lymphoma non-specific type (PTCL-NOS); (2) Angioimmunoblastic T-cell lymphoma (AITL); (3) AlK-systemic anaplastic large T-cell lymphoma (ALK-ALCL); (4) Stage III/IV extranodal NK/T cell lymphoma (NKTCL); (5) Other subtypes of PTCL that the researchers thought could be included; 3. ECOG Physical condition grade 0-2; 4. Basically normal heart, lung, liver and kidney function (No serious heart disease; No serious lung disease; Transaminase =1.5x10^9/L, HGB>=90g/L, PLT>=100x10^9/L; 6. No other serious diseases in conflict with the programme; 7. Predicted survival >=3 months with follow-up; 8. Voluntarily participate in the clinical trial and sign a written informed consent; 9. Researchers believe that subjects can benefit.

Exclusion criteria

Exclusion criteria: 1. Patients with leukemic PTCL (such as adult T-cell leukemia/lymphoma, etc.), or lymphoma leukemia stage (bone marrow examination lymphoma cell proportion >=20%), or central nervous system (CNS) involvement, or hemophagocytic syndrome; 2. HIV-Ab positive or HbsAg positive or HCV-Ab positive; 3. Patients with the following specific medical history, such as active autoimmune disease, type I diabetes, hypothyroidism requiring hormone replacement (except Hashimoto's thyroiditis), patients with severe mental illness, and patients with a history of organ transplantation; 4. Dilated cardiomyopathy, coronary heart disease with ST-segment depression on the ECG and previous myocardial infarction within the last 6 months; 5. Clinical symptoms of brain dysfunction and serious mental illness; 6. Pregnant or lactating patients; 7. The trial investigator considered it inappropriate to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Objective remission rate;

Secondary

MeasureTime frame
Progression-free survival time;Safety;

Countries

China

Contacts

Public ContactLiang Xiping
liangxiping2006@163.com+86 13368064180

Outcome results

None listed

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