Status:
UNKNOWN
PD-1 Antibody, Chidamide, Lenalidomide and Gemcitabine for Peripheral T-cell Lymphoma
Lead Sponsor:
Mingzhi Zhang
Conditions:
Peripheral T-cell Lymphoma
Eligibility:
All Genders
14-65 years
Phase:
PHASE4
Brief Summary
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.
Detailed 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 tri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04040491
Start Date
September 1 2019
End Date
September 1 2021
Last Update
May 12 2020
Active Locations (1)
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1
Oncology Department of The First Affilliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052