Clinical trial · Interventional
PD-1 Antibody, Chidamide, Lenalidomide and Gemcitabine for Peripheral T-cell Lymphoma
Single-arm, Multi-center Clinical Study of PD-1 Antibody, Chidamide, Lenalidomide and Gemcitabine for Peripheral T-cell Lymphoma
NCT04040491CI-TRIAL-00045053unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To observe the safety, tolerability and clinical effects of PD-1, chidamide, lenalidomide and gemcitabine in the treatment of newly diagnosed and relapse/refractory peripheral T-cell lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral T-cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Newly diagnosed PTCL
- description
- PD-1 Antibody: 200mg, d1, Chidamide: 30mg, twice a week, Lenalidomide: 10mg, d1-10 gemcitabine:600mg/m2, d1 and 21 days made one treatment cycle.
- interventionNames
- Drug: PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine
- type
- OTHER
- label
- Relapse/refractory PTCL
- description
- PD-1 Antibody: 200mg, d1, Chidamide: 30mg, twice a week, Lenalidomide: 10mg, d1-10 gemcitabine:600mg/m2, d1 and 21 days made one treatment cycle.
- interventionNames
- Drug: PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine
Primary outcomes (3)
- measure
- Overall Response Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * age:14-65 years;Eastern Cooperative Oncology Group (ECOG)score≤3;expected survival≥3 months * patients with Peripheral T-cell Lymphoma diagnosed by immuno-histochemistry (IHC); * acceptable hematological indicators, no chemotherapy contraindications; * total bilirubin ≤ 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 2.5 x upper age limit (ULN), if the abnormal laboratory parameters are considered to be caused by lymphoma, patients Eligible conditions should be adjusted to be incorporated into the group; * At least one measurable lesion by CT or PET-CT(Positron Emission Tomography-Computed Tomography); * exclude other major diseases, normal heart and lung function; * Female patients of childbearing age are negative for pregnancy test; * Cooperate with follow-up; * There are no other related treatments including traditional Chinese medicine, immunotherapy, and biologic therapy (except for the treatment of anti-bone metastases and other symptoms); * Signing informed consent \*: Pathological histology must be consulted by a pathologist at a provincial hospital. Exclusion Criteria: * Patients with ALK-positive Anaplastic Large Cell Lymphoma or angioimmunoblastic T-cell lymphoma * rejecting providing blood preparation; * allergic to drug in this study and with metabolic block; * rejecting adopting reliable contraceptive method in pregnancy or lactation period; * uncontrolled internal medicine disease(including uncontrolled diabetes,severe incompetence cardiac, lung, liver and pancreas); * with severe infection; * with primary or secondary central nervous system tumor invasion; * with immunotherapy or radiotherapy contraindication; * ever suffered with malignant tumor; * having peripheral nervous system disorder or dysphrenia; * with no legal capacity,medical or ethical reasons affecting research proceeding; * participating other clinical trials simultaneously; * adopting other anti-tumor medicine excluding this research; * Patients with immunodeficiency, such as primary immunodeficiency syndrome or organ transplant recipients * Human immunodeficiency virus (HIV)-positive patients * the researchers considering it inappropriate to participate in the study. * Patients with immune system diseases
References
Publications (0)
Data not yet available
No reference posted for this study.