Clinical trial NCT04040491: PD-1 Antibody, Chidamide, Lenalidomide and Gemcitabine for Peripheral T-cell Lymphoma
Official title: Single-arm, Multi-center Clinical Study of PD-1 Antibody, Chidamide, Lenalidomide and Gemcitabine for Peripheral T-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Peripheral T-cell Lymphoma
Keywords: PD-1
chidamide
lenalidomide
gemcitabine
Peripheral T-cell Lymphoma
Lead sponsor: Zhengzhou University
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Intervention model description: 50 patients for newly diagnosed group and 50 patients for relapse/refractory group.
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Response Rate
timeFrame: From date of randomization until the date tumor volume has reduced, assessed up to 36 months
measure: Progression-free Survival
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
measure: Overall Survival
timeFrame: From date of randomization until date of death from any cause, assessed up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Oncology Department of The First Affilliated Hospital of Zhengzhou University
state: Henan
Study officials:
References: