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A study for combined with chidamide miantenance therapy after chidamide and azacitidine+CHOP sequential autologous hematopoietic stem cell transplantation in the first diagnosised III / IV stage peripheral T cell lymphoma

A study for combined with chidamide miantenance therapy after chidamide and azacitidine+CHOP sequential autologous hematopoietic stem cell transplantation in the first diagnosised III / IV stage peripheral T cell lymphoma

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043966
Enrollment
Unknown
Registered
2021-03-06
Start date
2021-02-21
Completion date
Unknown
Last updated
2021-07-12

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

Conditions

peripheral T cell lymphoma

Interventions

experimental group:combined with chidamide miantenance therapy after chidamide and azacitidine+CHOP sequential autologous hematopoietic stem cell transplantation

Sponsors

Chongqing University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 treated first III / IV peripheral t-cell lymphoma (with the exception of NK/T lymphoma and ALK positive anaplastic large cell lymphoma), gender not limited; 2. Informed consent has been signed prior to carrying out any particular research operation; 3. The patient has adequate organ function, including: Absolute neutrophil count >= 1.5 x 10^9/L;Hemoglobin >= 80g/L, platelet count >= 75 x 10^9/L; Total bilirubin level <= 1.5 x upper limit of normal (ULN), aspartate aminotransferase (AST), alanine aminotransferase (ALT) <= 2.5 x ULN; Serum creatinine level <= 1.5 x ULN; Prothrombin time (PT) or activated partial thromboplastin time (APTT) or international standardized ratio (INR) <= 1.5 x ULN without anticoagulant therapy; 4. For men or women of reproductive age who have not undergone sterilization, consent to effective contraception during the treatment period and for 12 months after the last study drug is administered; 5. Expected survival time is at least 3 months, as determined by the investigator.

Exclusion criteria

Exclusion criteria: 1. Patients with severe cardiac insufficiency with cardiac ejection fraction EF below 60%;Or severe arrhythmias that the researchers evaluated as intolerable to preconditioning; 2. Patients with severe pulmonary insufficiency (obstructive and/or restrictive ventilation disorders) who were not able to tolerate the preconditioning regimen as assessed by the investigator; 3. With severe liver function impairment, liver function indexes (ALT, TBIL) were more than 3 times higher than the upper limit of normal value (ULN);Those who were not able to tolerate the pretreatment regimen as assessed by the investigator; 4. Patients with severe renal insufficiency, with renal function index (CR) more than twice the upper limit of normal (ULN);Or those with a 24-hour urinary creatinine clearance rate of less than 50ml/min, who were not able to tolerate the pretreatment regimen as assessed by the investigator; 5. Severe active infection before transplantation and unable to tolerate preconditioning as evaluated; 6. Can't understand or follow this program with clinical symptoms of brain dysfunction or serious mental illness; 7. Women who are pregnant, preparing to become pregnant or lactating; 8. Complicated with other malignant tumors requiring treatment; 9. Those deemed unsuitable for inclusion by the researcher.

Design outcomes

Primary

MeasureTime frame
objective remission rate;

Secondary

MeasureTime frame
side effects;Patient tolerance;progress free survial;Duration of remission;

Countries

China

Contacts

Public ContactYao Liu

Chongqing University Cancer Hospital

648283926@qq.com+86 13228684685

Outcome results

None listed

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