Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02753543
Other study ID # RJ-PTCL-2016-01
Secondary ID
Status Recruiting
Phase Phase 2
First received April 19, 2016
Last updated November 10, 2017
Start date November 2015
Est. completion date November 2019

Study information

Verified date November 2017
Source Ruijin Hospital
Contact Weili Zhao, MD, PhD
Phone 64370045
Email zhao.weili@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single arm, prospective trial to evaluate the efficacy and safety of Chidamide in combination with previous chemotherapy in peripheral T cell lymphoma patients who did not achieve complete response after 3 cycles of chemotherapy in interim evaluation.


Recruitment information / eligibility

Status Recruiting
Enrollment 33
Est. completion date November 2019
Est. primary completion date November 2018
Accepts healthy volunteers No
Gender All
Age group 16 Years to 75 Years
Eligibility Inclusion Criteria:

- Pathologically verified peripheral T-cell lymphoma, partial response or stable disease after 3 cycles of CEOP (cyclophosphamide, epirubicin or doxorubicin, vincristine and prednisone) or CEOP(cyclophosphamide,vincristin,epirubicin and prednisone)/IVE (ifosfamide, epirubicin, etoposide)/GDP(Gemcitabine, Cis-platinum, Dexamethasone)

- Age ?16 years, ?75 years

- ECOG (Eastern Cooperative Oncology Group) =0,1,2

- No previous history of malignancy

- Radiologically measurable disease

- Life expectancy>6 months

- Informed consented

Exclusion Criteria:

- Active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy

- Lab at enrollment(unless caused by lymphoma)

- Neutrophile<1.5*10^9/L

- Platelet<75*10^9/L

- Hemoglobulin<90g/L

- ALT(alanine aminotransferase) or AST (aspartate aminotransferase ) >2*ULN,AKP(alkaline phosphatase) or bilirubin >1.5*ULN (upper limit of normal )

- Creatinine>1.5*ULN

- Other uncontrollable medical condition that may that may interfere the participation of the study

- Not able to comply to the protocol for mental or other unknown reasons

- Pregnant or lactation

- HIV infection

Study Design


Intervention

Drug:
Chidamide


Locations

Country Name City State
China Ruijin Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary complete response 21 days after 3 cycles of chidamide in combination with chemotherapy (each cycle is 21 days)
Secondary Progression free survival 1 year
Secondary Overall survival 1 year
Secondary Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 Each cycle of treatment and then every 3 months for 1 year(each cycle is 21 days)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04526834 - Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma Phase 1
Recruiting NCT04390737 - Evaluate the Safety and Clinical Activity of HH2853 Phase 1/Phase 2
Recruiting NCT05559008 - A Umbrella Study in R/R PTCL Guided by Molecular Subtypes Phase 1/Phase 2
Recruiting NCT06083701 - Phase I/II Study of Linperlisib Plus Chidamide for R/R Peripheral T-cell Lymphoma: a Prospective, Multi-center Study Phase 1/Phase 2
Not yet recruiting NCT02856997 - Chidamide With ICE Regimen for Relapsed/Refractory Peripheral T Cell Lymphoma Phase 2
Recruiting NCT04083495 - CD30 CAR for Relapsed/Refractory CD30+ T Cell Lymphoma Phase 2
Not yet recruiting NCT05979792 - Clinical Study of CD7 CAR-T Cell Injection in the Treatment of Patients With Relapsed or Refractory CD7-positive Peripheral T Cell Lymphoma Early Phase 1
Recruiting NCT04984837 - Study of Lacutamab in Peripheral T-cell Lymphoma Phase 2
Recruiting NCT06072131 - To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL Phase 3
Completed NCT01716806 - A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL) Phase 2
Terminated NCT03947255 - A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma Phase 2
Recruiting NCT04028440 - γδT Cells Immunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL) Early Phase 1
Not yet recruiting NCT05923502 - (CHANT)Real World Study of Duvelisib in the Treatment of Non-Hodgkin's Lymphoma (NHL)
Recruiting NCT05377827 - Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies Phase 1
Recruiting NCT05883449 - Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL Phase 2
Active, not recruiting NCT03586999 - Nivolumab With Standard of Care Chemotherapy for Peripheral T Cell Lymphomas Phase 1/Phase 2
Recruiting NCT04489264 - The Role of Consolidative Autologous Stem Cell Transplantation After First-line Therapy in Peripheral T Cell Lymphoma
Recruiting NCT06151106 - Chidamide and Duvalisibon for the Treatment of Refractory/Relapsed Peripheral T-cell Lymphoma Phase 2
Not yet recruiting NCT06089941 - Circulating Tumor DNA Sequencing in Patients With Peripheral T-cell Lymphomas
Recruiting NCT06131801 - Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution