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The combined regimen of Chidamide with Prednisone, Cyclophosphamide, Etoposide, and Methotrexate for Relapsed/ Refractory Peripheral T Cell Lymphoma (PTCL), a multicenter, single arm, open-label phase II clinical trial

The combined regimen of Chidamide with Prednisone, Cyclophosphamide, Etoposide, and Methotrexate for Relapsed/ Refractory Peripheral T Cell Lymphoma (PTCL), a multicenter, single arm, open-label phase II clinical trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIC-15006786
Enrollment
Unknown
Registered
2016-06-18
Start date
2016-06-01
Completion date
Unknown
Last updated
2017-04-18

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

1: Chidamide with Prednisone, Cyclophosphamide, Etoposide, and Methotrexate

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Pathologically diagnosed peripheral T cell lymphoma (PTCL), exclude NK/T cell lymphoma; 2. Patients with non-remission or relapse following remission after at least one session of systemic treatment (including chemotherapy, stem cell transplantation, ect); 3. Patients unavailable for hemapoietic stem cell transplantation for various reasons; 4. Aged 18 to 75 years old, male or female; 5. ECOG value 0-1; 6. The absolute value of neutriphils >=1.5×10^9/L, platelet >=90×10^9/L, Hb >=90g/L; 7. Expected survival >=3 months; 8. Did not have radiotherapy, chemotherapy, targeted therapy, or hemapoietic stem cell transplantation within the past 4 weeks prior to inclusion; 9. Willing to sign the written consent.

Exclusion criteria

Exclusion criteria: Patients with any of the folling should be excluded: 1. Women during pregnancy, lactation or fertile women who are not willing to take contraceptive measures; 2. Patients with >=10mm end-diastolic pericardial dark zone on cardiac ultrasonography; 3. Patients with transplanted organ/organs; 4. Patients that have received symptomatic treatment for bone-marrow toxicity within 7 days prior to inclusion; 5. Patients with active hemorrhage; 6. Patients with impaired liver function (Total bilirubin >=1.5 times of the normal maximum, ALT/AST >=2.5 times of the normal maximum. or ALT/AST>=5 times of the normal maximum for patients with infiltrative liver disease), impaired renal function (serum creatinin >=1.5 times of the normal maximum), abnormal electrolyte metabolism; 7. Patients with mental disorders or those who could not agree to consent; 8. Patients with drug use or long-time alcoholism that would impact the result of the trial; 9. Patients that the researchers find not suitable for the trial.

Design outcomes

Primary

MeasureTime frame
objective remission rate;

Secondary

MeasureTime frame
duration of remission;progression free survival;overall survival;

Countries

China

Contacts

Public ContactZhiming Li

Sun Yat-sen University Cancer Center

drlizhiming@163.com+86 15821531560

Outcome results

None listed

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