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PD-1 Antibody, Chidamide, Lenalidomide and Gemcitabine for Peripheral T-cell Lymphoma

M

Mingzhi Zhang

Status and phase

Unknown
Phase 4

Conditions

Peripheral T-cell Lymphoma

Treatments

Drug: PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT04040491
hnslblzlzx20190702

Details and patient eligibility

About

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.

Full description

Patients with peripheral T-cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional CHOP regimen. The investigators have been proceeding this trial to evaluate the efficacy and safety of the PD-1, chidamide, lenalidomide and gemcitabine in the treatment of newly diagnosed and relapse/refractory peripheral T-cell lymphoma.

Enrollment

100 estimated patients

Sex

All

Ages

14 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Newly diagnosed PTCL
Experimental group
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.
Treatment:
Drug: PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine
Relapse/refractory PTCL
Other group
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.
Treatment:
Drug: PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine

Trial contacts and locations

1

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Central trial contact

Mingzhi D Zhang

Data sourced from clinicaltrials.gov

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